Purchase_and_Maintenance_of_Quality_System_Management_Software_(Addendum_#1_Revision).pdf

County of Orange, Sheriff-Coroner

Invitation for Bid for Purchase and Maintenance of Quality System Management Software

IFB # 060-2855108

For more information, please visit our online supplier portal, located at https://procurement.opengov.com/portal/ocgov

COUNTY OF ORANGE

Sheriff-Coroner

PROCUREMENT SERVICES

320 N. Flower St.

Santa Ana, CA

92703

Date: Wednesday, June 4, 2025

INVITATION FOR BIDS

FOR: PURCHASE AND MAINTENANCE OF QUALITY SYSTEM MANAGEMENT

SOFTWARE

BID MUST BE RECEIVED BEFORE:

June 23, 2025 / 4:00 pm

IFB # 060-2855108

Procurement Services Regular Office Hours:

8:00 AM to 5:00 PM

Monday through Friday

The office is closed between 12:00 PM and 1:00 PM

Table Of Contents

1. Summary & Background

2. General Information

3. General Instructions

4. Scope of Work

5. OCLSB and DVBE Preference Policies Certification Requirements

6. Electronic Fund Transfer (EFT)

7. Pricing

8. Vendor Responses

Attachments:

C - Model Contract IFB-060-2855108 Purchase and Maintenance of Quality System Management

Software

SECTION 1. Summary & Background

The County of Orange, Sheriff-Coroner, (hereinafter referred to as County) is requesting competitive bids from qualified vendors (hereinafter referred to as Bidder) for Purchase and Maintenance of Quality

System Management Software. The awarded Contract, (hereinafter referred to as Contract) will be between the County and awarded Bidder, (hereinafter referred to as Contractor) in accordance with the model contract terms, conditions and scope of work. This is a fully electronic solicitation – only electronic bids submitted through the County’s online bidding system will be allowed; no other form of bid submittals will be accepted. Prior to submitting a bid, Bidders are advised to carefully read the instructions below, including the model contract and any solicitation attachments and/or exhibits.

The Orange County Sheriff’s Crime Laboratory (OCCL) is accredited by ANSI National Accreditation Board to the International Organization for Standard (ISO) 17025. The OCCL holds two accreditations:

Testing, which includes the majority of services provided by the laboratory, and Breath Alcohol Calibration.

The OCCL procured a quality system management software in 2020 to manage the accreditation and quality assurance program for the laboratory. The tool has served the laboratory well for the past four years;

however, the laboratory requires a more robust and adaptable solution to more effectively manage the complex quality assurance activities.

SECTION 2. General Information

2.1 IMPORTANT NOTICE

The County has attempted to provide all information available. It is the responsibility of each Bidder to review, evaluate, and, where necessary, request any clarification prior to submission of a bid. If any person contemplating submitting a bid in response to this IFB is in doubt as to the true meaning of any part of the solicitation documents attached hereto or finds discrepancies in or omissions from the specifications, they must submit a written request for clarification/interpretation to the County Deputy Purchasing Agency

(DPA) via the County’s online biding system.

County of Orange IFB

Sheriff-Coroner - Purchase and Maintenance of Quality System Management Software, 060-2855108

2.2 COMMUNICATION

Bidders are not to contact other County personnel with any questions or clarifications concerning this

Invitation for Bid (IFB). County will provide all official communication concerning this IFB. Any County response relevant to this IFB other than through or approved by County is unauthorized and will be considered invalid.

All questions regarding this IFB must be submitted via the County’s eProcurement Portal at:

https://procurement.opengov.com/portal/ocgov.

2.3 CLARIFICATION/INTERPRETATION

If clarification or interpretation of this solicitation is considered necessary by County, a written addendum shall be issued and the information will be posted on County’s online bid system. Any interpretation of, or correction to, this solicitation will be made only by addendum issued by the County DPA. All addenda will be submitted and posted on the County’s online bidding system. It is the responsibility of each Bidder to periodically check the County’s online biding system to ensure that they have received and reviewed any and all addenda to this solicitation. The County will not be responsible for any other explanations, corrections to, or interpretations of the documents, including any oral information.

All questions or requests for interpretation must be received by Tuesday, June 17, 2025 before 4:00 pm.

2.4 BID VALIDITY

Bids will be valid for a period of 365 days after IFB closing date.

2.5 IMPORTANT DATES

These dates only apply to IFB # 060-2855108

IFB Post Date: June 4, 2025

Question Submission Deadline: June 17, 2025, 4:00pm

Electronic Bids & Bid Security Due Before: June 23, 2025, 4:00pm

2.6 LOBBYISTS

County of Orange does not require and neither encourages or discourages the use of lobbyists or other consultants for the purpose of securing business.

ORANGE COUNTY BOARD OF SUPERVISORS

AND COUNTY AGENCY OFFICERS

Board of Supervisors

Janet Nguyen, First District Vicente Sarmiento, Second District

Donald P. Wagner, Chairman, Third District

Doug Chaffee, Vice Chairman, Fourth District Katrina Foley, Fifth District

County Agency Officers

Claude Parrish, Assessor Hugh Nguyen, Clerk-Recorder

Todd Spitzer, District Attorney-Public Administrator Don Barnes, Sheriff-Coroner

Shari L. Freidenrich, Treasurer-Tax Collector Andrew Hamilton, Auditor-Controller

SECTION 3. General Instructions

3.1 REVIEW

Before submitting a bid, Bidders shall carefully review the General Instructions and examine the solicitation contents, including the Model Contract Terms, Conditions and Scope of Work. Bidders shall include in their bid response a monetary sum to cover the cost of all items included in the Contract. The Model

Contract contained in this solicitation is the Contract proposed for execution. Upon award, awarded Bidder will be required to sign and submit Contract for execution.

3.2 RESPONSIVENESS

Responsive bids shall include completed submittals/attachments provided in the .

3.3 BID SUBMISSION

Electronic Bids shall be submitted via the County’s online bidding system via the following link https://procurement.opengov.com/portal/ocgov. All required sections of the IFB as listed above, must be submitted via the County’s eProurement Portal. Bidder is solely responsible for “on time” submission of their electronic bid. The County will not accept late bids and no exceptions shall be made. County will only receive those bids that were transmitted successfully.

Note: Electronic Bids cannot be viewed by County until after the IFB deadline. If you encounter any problems with your registration, system, bid submission, or other system issues please contact OpenGov’s support staff via the live chat option or via email at procurement-support@opengov.com.

3.4 AWARD

Upon recommendation of Contract award, Bidder will be required to submit the following documents within seven (7) days of County notification, unless otherwise specified in the solicitation:

A. Insurance: Certificate(s) of Insurance, including additional Insured Endorsement(s); refer to Model

Contract, Article O-Insurance

B. W-9 Form: Current signed W-9 (Taxpayer ID No & Certification), which includes Contractor’s

Legal Business Name(s). Out of State Vendors may be required to submit a 587/590 Form.

3.5 PRICING

A. Bid Prices: The bid prices quoted on this solicitation shall be firm for the entire contract term of the awarded Contract.

mailto:procurement-support@opengov.com

B. Addenda: Bid prices offered shall reflect all addenda issued by County.

C. Scope of Work: Bids shall be submitted only for the items and/or services as stated in the Scope of Work, Attachment A of Model Contract; bids for other than the items and/or services listed will not be considered.

D. Firm Prices: The County will only consider firm price bids.

E. Profit: The net amount of profit will remain firm for the entire term of the Contract. Contract adjustments which increase Contractor’s profit will not be allowed.

F. Price Decreases: All price/rate decreases will automatically be extended to the County. Please reference Paragraph – Price Increase/Decrease provision for additional information.

G. Acceptance: Bids must be provided for each item separately, “all-or-none” bids will not be accepted unless in the best interest of the County.

3.6 NO SUBSTITUTIONS

The bidder is required to meet all specifications and requirements contained in this solicitation. No substitutions will be accepted, unless prior County written approval is received.

3.7 DISCREPANCIES

Bidder shall take all responsibility for any errors or omissions in their bids. Any discrepancies in numbers or calculations shall be interpreted to reflect the lowest price to the County.

If prior to contract award, a Bidder discovers a mistake in their bid which renders the Bidder unwilling to perform under any resulting contract, the Bidder must immediately notify the buyer and request to withdraw the bid. It shall be solely within the County's discretion as to whether withdrawal will be permitted. If the solicitation contemplated evaluation and award of "all or none" of the items, then any withdrawal must be for the entire bid. If the solicitation provided for evaluation and award on a line item or combination of items basis, the County may consider permitting withdrawal of specific line item(s) or combination of items.

3.8 BID EXPENSES

The County shall not be liable for any expenses incurred by potential Contractors in the preparation or submission of their bids. Pre-contractual expenses are not to be included in the Contractor’s Pricing Sheet.

Pre-contractual expenses are defined as, including but not limited to, expenses incurred by Bidder in:

A. Preparing its bid in response to this IFB.

B. Submitting that bid to the County.

C. Negotiating with the County any matter related to the bid; and, D. Any other expenses incurred by the Bidder prior to the date of the award and execution, if any, of the Contract.

3.9 PROTESTS

In the event a Bidder believes that County’s solicitation is unfairly restrictive or ambiguous or contains conflicting provisions or the Bidder believes that any resulting Contract would be commercially impractical to perform, the Bidder must file a written protest with the County DPA at elara@ocsheriff.gov.

A. Procedure All protests shall be typed under the protester’s letterhead and submitted in accordance with the provisions stated herein. All protests shall include at a minimum the following information:

1. The name, address and telephone number of the protester.

2. The signature of the protester or the protester’s representative.

3. The solicitation or contract number.

4. A detailed statement of the legal and/or factual grounds for the protest; and

5. The form of relief requested.

B. Protest of Bid Specifications:

1. All protests related to bid specifications must be submitted to the County DPA no later than five (5) business days prior to the close of the bid. Protests received after the five (5) business day deadline will not be considered by the County.

2. In the event the protest of specifications is denied, and the protester wishes to continue in the solicitation process, they must still submit a bid prior to the close of the solicitation in accordance with the bid submittal procedures provided in the bid.

C. Protest of Award of Contract:

In protests related to the award of a contract, the protest must be submitted no later than five (5) business days after the notice of the proposed contract award is provided by the County

DPA. Protests relating to a proposed contract award which are received after the five (5) business day deadline will not be considered by the County.

1. Protest Process

a. In the event of a timely protest, the County shall not proceed with the solicitation or award of the contract until the County DPA, the County Procurement Officer or the Procurement

Appeals Board renders a decision on the protest.

b. Upon receipt of a timely protest, the County DPA will within ten (10) business days of the receipt of the protest, issue a decision in writing which shall state the reasons for the actions taken.

c. The County may, after providing written justification to be included in the procurement file, make the determination that an immediate award of the contract is necessary to protect the substantial interests of the County. The award of a contract shall in no way compromise the protester’s right to the protest procedures outlined herein.

d. If the protester disagrees with the decision of the County DPA, the protestor may submit a written notice to the Office of the County Procurement Officer requesting an appeal to the

Procurement Appeals Board, in accordance with the process stated below.

B. Appeal Process

A. If the protester wishes to appeal the decision of the County DPA, the protester must submit, within three (3) business days from receipt of the County DPA’s decision, a written appeal to:

Email: CPOAppeals@ocgov.com mailto:CPOAppeals@ocgov.com

Or

County of Orange/County Procurement Office

400 West Civic Center Drive, 5th Floor

Santa Ana, CA 92701

B. Within fifteen (15) business days, the County Procurement Officer will review all materials in connection with the grievance, assess the merits of the protest and provide a written determination that shall contain his or her decision on whether the protest shall be forwarded to the Procurement Appeals Board.

C. The decision of the County Procurement Officer on whether to allow the appeal to go forward will be final and there shall be no right to any administrative appeals of this decision.

3.10 ACCEPTANCE/REJECTION/AWARD

A. Bids submitted in response to this IFB may become subject to public disclosure under the California

Public Records Act, and other applicable law. The County shall not be liable in any way for disclosure of any such records. Additionally, all bids shall become the property of the County.

B. The lowest responsive, responsible Bidder will be recommended for contract award.

C. Bids will be reviewed by the County for responsiveness to all requirements. The County has the right to reject any bid deemed unresponsive or lacking the resources or experience to adequately perform the services described herein.

D. Only those responsible, responsive bids meeting all solicitation requirements and specifications shall be further reviewed for consideration for award. Award shall be based on the lowest, responsive, responsible bid.

E. Please take notice, non-acceptance of the County of Orange terms and conditions, incorporated in model contract, may deem a bid non-responsive. County may not accept any other terms, conditions, or provisions contrary to those contained within this solicitation.

F. Final award determination shall be based upon the lowest responsive, responsible bid, and may also include a review of Bidder’s ability to meet the requirements and perform the services specified in this solicitation; Bidder’s references and past performance; and Bidder’s acceptance of County of

Orange terms and conditions. In addition, County reserves the right to verify and validate any information prior to Contract Award and during the entire term of the Contract.

G. By submitting a response to this solicitation, Bidders agree to accept the decision of the County

DPA as final.

H. Awarded Bidder will be required to sign a contract upon award. If Bidder is a corporation, signature will be provided in accordance with the corporation’s code as specified in this solicitation.

3.11 RIGHTS RESERVED TO COUNTY

The County reserves the right to:

A. Waive, at its discretion, any irregularity or informality, which County deems correctable or otherwise not warranting rejection of the bid.

B. County reserves the right, at its sole discretion, to make multiple awards to Bidders for services requested in this solicitation.

C. Accept or reject in whole or in part any or all bids received as a result of this solicitation at its sole discretion and to solicit for new bids, as the best interest of the County may require.

D. Negotiate the final Contract with the lowest, responsive and responsible Bidder or Bidders as necessary to serve the best interests of the County.

E. Withdraw or cancel in part or in its entirety this solicitation at any time without prior notice and furthermore makes no representation that any contract will be awarded to any Bidder responding to this solicitation.

F. Award its total requirements to one Bidder or to apportion those requirements among two or more

Bidders as the County may deem to be in its best interests; therefore, bids must be provided for each item separately; “all-or-none” bids will not be accepted unless in the best interest of the

County.

3.12 JOINT BIDS

Where two or more Bidders desire to submit a single bid in response to a solicitation, they must do so on a prime/subcontractor basis rather than as a joint venture. The County intends to contract with a single firm or multiple firms, but not with multiple firms doing business as a joint venture.

3.13 UNFAIR PRACTICES AND OTHER LAWS

Bidder warrants that its bid complies with the Unfair Practices Act (Business and Professions Code Section

17000 et seq.) and all applicable County, State and Federal laws and regulations.

3.14 INDEPENDENCE OF BID

By submitting a bid, Bidder swears under penalty of perjury that it did not conspire with any other supplier to set prices in violation of anti-trust laws.

3.15 AMERICANS WITH DISABILITY ACT (ADA)

To comply with the non-discrimination requirements of the ADA, it is the policy of the County to make every effort to ensure that its programs, activities and services are available to all persons, including persons with disabilities. For persons with a disability needing a reasonable modification to participate in the procurement process, or for persons having questions regarding reasonable modifications for the procurement process, you must contact the buyer listed in the solicitation.

3.16 DUNS NUMBER

The County requires a valid D-U-N-S number prior to Contract Award. If needed, your company may obtain one at no cost at www.dnb.com. If you are unable to provide/obtain a D-U-N-S number, please indicate so in your bid submission response.

3.17 UNIQUE ENTITY IDENTIFIER NUMBER (UEI)

The County requires a valid UEI number prior to Contract Award of Human Services. If needed, your company may obtain one at no cost at www.usfcr.com. If you are unable to provide/obtain a UEI number, please indicate so in your bid submission response.

SECTION 4. Scope of Work

4.1 QUALITY SYSTEM MANAGEMENT SOFTWARE

1. Introduction

The Orange County Sheriff’s Crime Laboratory (OCCL) is accredited by ANSI National Accreditation Board to the

International Organization for Standard (ISO) 17025. The OCCL holds two accreditations: Testing, which includes the majority of services provided by the laboratory, and Breath Alcohol Calibration. The OCCL procured a quality system management software in 2020 to manage the accreditation and quality assurance program for the laboratory.

The tool has served the laboratory well for the past four years; however, the laboratory requires a more robust and adaptable solution to more effectively manage the complex quality assurance activities.

2. System Software and Licenses

The Contractor shall develop, deliver, install, configure and test all the Quality System Management software to include the following minimum number of concurrent licenses: 5 primary licenses and 10 secondary licenses. The

Contractor will be responsible for installing any client software that is required other than standard browsers on all workstations at initial and subsequent phase sites. All licensing agreements associated with this contract must extend for the life of this project and be in the name of the County.

3. Data Ownership and Portability

The data provided by OCCL and generated by the Quality System Management product shall be under the sole ownership of OCCL. At the request of OCCL, contractor shall make available all data, documents, and associated information in a readable format.

4. Third Party Software

The Contractor shall provide, deliver, install, configure and test all third-party software that is required to support the operation of the Quality System Management solution on Microsoft Windows 11, with forward compatibility. All warranties associated with this software must be in the name of the County.

5. System Management and Security

The Contractor shall provide, deliver, install, configure and test all software, servers, and network infrastructure that is required to securely and effectively host, manage, and maintain the Quality System Management software solution in a cloud-based environment that meets the following criteria:

5.1 Secure encrypted hosting environment located within the United States

5.1.1 NIST SP 800-53r5 compliant

5.1.2 CJIS Security Policy v6.0 compliant

5.2 Include both a Live and Training environment to allow for the development of workflows/procedures prior to pushing into production

5.3 ISO27001 Accredited

5.4 21 Code of Federal Regulations Part 11 technical controls including but not limited to session timeout and audit log

5.5 Designed with strict access controls

5.6 Designed with audit logging

5.7 Include multi-factor authentication

5.8 Includes regular security reviews to maintain CJIS compliance

5.9 Includes regular vulnerability assessments and continuous monitoring

5.9.1 Including incident response and reporting

5.10 Includes disaster recovery

5.11 Maintains high availability and redundancy

5.12 SSO (Single sign on) capability

5.13 Accessible 24 hours/day via a web-browser, mobile application, and/or desktop application

5.14 At least 60GB of data storage

5.15 Include all upgrades and patches at no additional cost

6. Controlled Document Management Module

These requirements are to facilitate the easy creation, approval, distribution, review, revision, change control and archiving of controlled documents, such as the Laboratory’s Quality System Manual and individual Section

Manuals. The solution shall:

6.1 Allow for uploading documents

6.2 Include the ability to create new document records based on ones that are already in the system to save user input time

6.3 Be able to create links to relevant resources such as statutory or accreditation information

6.4 Include the ability to initiate and automatically notify all stakeholders using email for approval purposes in a defined sequence specific to that document or type of document

6.5 Provide a facility to review all approvals before the new document or version is placed into active service

6.6 Provide the facility to extract a copy of the document out of the database should it be stored within the database

6.7 Provide a secure mechanism to control the change of document content independent of storage method

6.8 Allow nominated individuals to be responsible for them in different roles, such as owners, authors, approvers, copyholders and reviewers

6.9 Allow users to categorize different types of documents, Work Instructions, SOPs, Policy, and / or Guidelines

6.10 Be able to define approver and workflow rules to different types of documents, rules should be given names, and it should be possible to change these or delete them

6.11 Allow users to accept comments when approving documents for accepting or rejecting, and have a mechanism to withdraw and re submit for approval

6.12 Allow new versions of documents to be created

6.13 Provide automatic version numbering

6.14 Be able to take documents out of service because the version is no longer appropriate or relevant

6.15 Allow users to confirm they have 'acknowledged' receipt of a document, for ‘Read and understood’ purposes

6.16 Be able to add, remove and print a list of ‘acknowledged’ users

6.17 Be able to schedule review dates required for documentation management and for the system to auto set the review date when a new document is uploaded or released for the first time

6.18 Allow a user to easily search for a document and once found, they should be able to see all other documents that are associated to the one they have found

6.19 Allow users to view the document and all relevant document details, both online and offline through the use of a mobile device

6.20 Allow users to retrieve and view documents controlled by the system, from the company’s intranet or other company business systems

6.21 Be able to control which users can print records held within the system. It is recognized that information rights management may be required to control printing of documents created using Microsoft applications, and that bespoke document formats may also require additional security to prevent printing from within their native application(s)

6.22 Be able to produce a report of who has ‘Acknowledged’ documents and when

6.23 Provide for reports of document status, number in place, number being reviewed, number out of review period, report of each document revision and changes associated with it

6.24 Allow documents to be associated with one or many Laboratory Sections, Standards, Procedures, and other documents

6.25 Allow documents to be linked with Non-Conformances, audits, reporting and competency

6.26 Record old document versions and record changes

6.27 Record all version approval comments

6.28 Allow for historical document viewing

6.29 Allow authorized staff to be able to enter or amend data through the use of person or role specific permissions

6.30 Maintain a log of when and who has made changes to a document

6.31 Permit automated notifications at key stages within the document control process

6.32 Permit automated notification reminders and escalations of outstanding work within the document control process

6.33 Provide the ability to define security permissions per user, per group, and per user role

6.34 Provide native PDF output

6.35 Provide hyperlink capability, both within the document and with other documents maintained in the software database

6.36 Be able to hyperlink external accreditation requirements within the documents

6.37 Index all documents to search the entire document group for specific words

6.38 Provide tracking, maintaining documents, as well as clearing obsolete documents in a safe manner that is compliant with legal hold requirements

6.39 Provide for unlimited document and workflow viewing without requiring any extra licensing

6.40 Be able to publish documents to OCCL’s intranet or other internal network system

6.41 Be able to update the header and footer of suite of documents without having to edit each individual document independently

7. Collaborative Document Review Module

These requirements are for the system to facilitate straight forward review/collaboration for proposed changes to the

OCCL’s Quality Systems. The solution shall:

7.1 Allow multiple users to edit documents/work products simultaneously

7.2 Incorporate into or be compatible with the Quality Management System solution

7.3 Track all edits made to a document

7.4 If a separate module, mirror the same number of primary and secondary licenses as the core product

7.5 21 Code of Federal Regulations Part 11 compliant

8. Audit Module

These requirements are for the system to facilitate the easy planning, implementation, and evaluation of audits of the laboratory and provide a mechanism to facilitate their management to conclusion and enable the reporting of such events. The solution shall:

8.1 Permit customized checklists/plan

8.2 Integration with Document module

8.3 Mobile access capability

9. Corrective Action/Non-Conformance/Correction Recording, Reporting, Investigation and Risk

Management Modules

These requirements are for the system to facilitate the easy recording of potential nonconformance events from all areas of the laboratory and provide a mechanism to facilitate their management to conclusion and enable the reporting of such events. The solution shall:

9.1 Enable the easy recording of all relevant information regarding the event, to facilitate any required event management

9.2 Permit the specification of numbering sequences, which may be assigned to one or more event types. Such numbering shall be applied automatically, although the allocated number may be amended, where required, by authorized users

9.3 Provide flexibility in reporting fields. Fields shall be in accordance with County’s previous system and shall be editable by the County and shall permit the creation, editing, archiving and deletion of fields

9.4 Permit automatic notifications of a new event to the event owner and other specified recipients

9.5 Permit the changing of the status of an event, e.g. Open, Pending or Closed for example

9.6 Permit the association of an event with, e.g. processes, documents, standards, products, etc.

9.7 Permit the adding of attachments, e.g. files, folders or URL’s to an event record

9.8 Provide the ability to pre-populate fields with appropriate values and pre-define the event management path to be taken, dependent on the event type, e.g. initial investigation, corrective action, preventive action, etc

9.9 Allow nominated individuals to be responsible for different steps of the event management process

9.10 Permit automatic notification to event management step owners and other specified recipients

9.11 Provide the ability to specify target dates for the completion of each of the event management steps and the overall event

9.12 Permit the addition, and removal, of event management steps for an event and the addition, and removal, of actions within event management steps

9.13 Facilitate the viewing of Event Records by system users

9.14 Restrict what a user may view through the use of personal/group access rights and permissions

9.15 Permit the classification of a field as ‘Confidential’, preventing users without sufficient permissions from viewing or filling in this field

9.16 Provide a range of graphical analysis tools to present and understand the information recorded in order to identify opportunities for continuous improvement

9.17 Allow only authorized staff to be able to enter or amend data through the use of person or role specific permissions

9.18 Permit automated notifications at key steps within the event process

9.19 Permit automated notification reminders and escalations of outstanding work within the event process

9.20 Provide the ability to define security permissions per user, per group of users and per user role

9.21 Provide for the ability to allow electronic signature for key activities and approvals

9.22 Permit the submitting of summary reports electronically to an assigned party

9.23 Permit custom report template generation

9.24 Facilitate trend and root-cause analysis

9.25 Enable the identification and management of hazards

9.26 Permit configurable quantification matrices

9.27 Provide visual representation and communication tools

10. Training and Competency Record Management Modules

These requirements are for a system that will facilitate the creation and maintenance of a master list of employees and provide the capability for storing training records, reviews and proficiency test results. It shall facilitate the scheduling of training in response to any identified training needs, and regular training milestones defined by user job roles, competencies, and skill levels. The solution shall:

10.1 Provide the ability to upload training records

10.2 Provide the ability to create a training log

10.3 Provide the ability to track instrument Qualification/Authorization for each individual

10.4 Permit the addition, archiving and deletion of employees to/from the system

10.5 Permit the addition of a person into one or more logical groups of employees (reference groups) for ease of filtering and/or selection

10.6 Permit application or removal of job roles for an employee

11. Assets and Supplier Management Modules

These requirements are for a system that will facilitate the creation and maintenance of a list of assets and a list of approved suppliers for critical materials. The solution shall:

11.1 Provide Asset Record and Supplier Management to include the tracking of QA activities including:

11.1.1 Supplier and Asset Approval Workflows

11.1.2 Approved Supplier Records

11.1.3 Instrument Calibration Records

11.1.4 Instrument Maintenance Records

11.1.5 Instrument Maintenance Records

11.1.6 Quality Control Checks

11.1.7 Performance Checks

11.1.8 Validation and Verification

11.1.9 Nonconformance History

11.1.10 Expiration Dates

12. General Requirements

These requirements are for the general functionality of the solution. The system shall:

12.1 Be accessible to OCCL staff 24 hours a day via desktop application, web browser, and/or mobile application

12.2 Be compatible with existing OCCL databases and shall integrate with current OCCL Information Technologies

12.3 Be able to export reports to multiple formats, such as; pdf, Excel, and Microsoft Word

12.4 Be capable of data mining and packaging of such data into a user interface that is presented in a usable, secure format

12.5 Include customizable process management (workflow) capabilities

12.6 Allow for direct queries, import/export, etc. with OCCL databases

12.7 Be able to perform standard based auditing to accreditation or industry standards

12.8 Be able to search for and report on current and past accreditation process data

12.9 Be able to embed unlimited number of accreditation standards into the Quality System Manual

12.10 APIs to enable potential integration with other OCCL systems

13. Data Migration

The Contractor shall migrate all information contained withing the OCCL’s current on-premises Quality Management

Software (Q-Pulse v. 7.5) including, but not limited to the following:

13.1 All existing users/user data

13.2 Quality System Documents

13.3 Audit documents/results

13.4 Corrective Actions/Preventive Actions

13.5 Training Courses

13.6 Employee Profiles

13.7 Workflows

13.8 Suppliers

13.9 Assets/Equipment/Reagents/Standards/Instruments

13.10 Incidents

13.11 Forms

14. Software Installation, Training, and Review

Installation, training and review shall occur during a set schedule determined by both parties, the customer and the contractor. It should include but is not limited to the following:

14.1 Implementation preparation, including guidance to OCCL of what to prepare to install the software

14.2 Desktop application installation

14.3 Communication in preparation for implementation and onsite training

14.4 Training shall be offered on at least two different levels to thoroughly prepare laboratory personnel

14.4.1 Overview training shall be provided to at least (10) employees, including laboratory leadership and other designees. The training shall include the following topics, at minimum:

14.4.1.1 Logging in, managing the software, and user preferences

14.4.1.2 Software user interface familiarization

14.4.1.3 Document management module and setup

14.4.1.4 Document management process, editing, and publishing of documents

14.4.1.5 Collaborative workspace module

14.4.1.6 Training module setup and function

14.4.2 In-depth training shall be provided to at least (5) employees, as designated by laboratory leadership. The training shall be comprehensive (2 full 8 hour days, for example) and include the overview training topics as well as the topics below, at minimum:

14.4.2.1 Testing module setup and function

14.4.2.2 Set up training, associated with tests and/or documents

14.4.2.3 Workflow module, setup and example

14.4.2.3.1 Create a test, associated with documents

14.4.2.4 Build a workflow, custom fields, and routing

14.4.2.4.1 Miscellaneous administration items

14.4.2.4.2 Email and process communication functions

14.4.2.4.2.1 Email reminders

14.4.2.4.2.2 Email for scheduled task

14.4.2.5 Searching and indexing

14.4.2.5.1.1 How to index

14.4.2.5.1.2 How to set links

14.4.2.5.1.3 How to search

14.4.2.6 Reporting Module

14.4.2.6.1 How to create a report and export it to all available formats

14.4.2.6.2 How to create a report using a customer template

14.4.2.7 How to schedule recurring reports

14.4.2.8 Prepare an example of one of the modules (customer’s choice) and run through it with the contractor

14.4.2.9 Prepare a workflow and run through it with the contractor

14.5 System validation and testing

14.5.1 Testing of the system to validate that it is working properly with OCCL’s Network

14.5.2 Validation of all requirements in this scope of work

14.6 System Acceptance

14.6.1 Solution shall meet all specifications to the satisfaction of the Orange County Crime Laboratory

15. Software Reconfiguration Support

Reconfiguration support shall occur during a set schedule determined by both parties, the customer and the contractor.

The exact configuration support will be determined by the OCCL at the time of service. It should include but is not limited to the following:

15.1 At least 25 days (8 hrs/day) of reconfiguration support covering at least the following:

15.1.1 Workflow development for document control (changes, approvals, acknowledgements, and regular review)

15.1.2 Workflow development for corrective action/nonconformance procedures

15.1.3 Workflow development for internal audits and external assessments

15.1.4 Workflow for proficiency testing management

15.1.5 Workflow for Health and Safety training management

15.1.6 Workflow for employee on-boarding procedures

15.1.7 Workflow for supplier approval/monitoring

16. Ongoing Technical Support and Maintenance

Contractor shall ensure the system performs all to the specifications in this scope of work. After system acceptance and any warranty period, contractor shall provide annual support and maintenance to include:

16.1 Continuous Cloud hosting on a U.S. based site

16.2 Offsite technical support to include web, email, and phone support available 24/ 7

16.3 Priority escalation response and resolution times, for example

16.3.1 Priority 1 – Critical - Response within 1 hour, resolution within 4 hours

16.3.2 Priority 2 – Major - Response within 4 hours, resolution within 8 hours

16.3.3 Priority 3 – Moderate - Response within 8 hours, resolution within 24 hours

16.3.4 Priority 4 – Minor - Response within 12 hours, resolution within 48 hours

16.4 Unlimited access to user group/community portal

16.5 Web-based “How to” guides

16.6 Unlimited access to knowledge base articles and e-learning

16.7 System uptime of at least 99.7% per month

16.7.1 OCCL to receive a service credit of 10% if uptime falls below 99.7%

16.7.2 OCCL to receive a service credit of 20% if uptime falls below 99.5%

SECTION 5. OCLSB and DVBE Preference Policies Certification Requirements

County of Orange Local Small Business (OCLSB) Preference and Disabled Veteran Business

Enterprise (DVBE) Preference Policies Certification Requirements

5.1 OCLSB:

OCLSB: Effective January 1, 2020, County of Orange Board of Supervisors adopted the OCLSB

Preference policy. Implementation of the OCLSB Preference policy supports local businesses, the local economy and the development of the County’s tax base.

To be certified as a Local Small Business by the County of Orange, a business shall meet (1) and (2) below:

A. Local Business Requirements:

1. maintains their principal center of operations (i.e. headquarters) within Orange County, and:

2. has:

a. a business address located in the County of Orange that is not a post office box, or

b. a valid business license or certificate of occupancy issued by the County of Orange or by an Orange County city, or other documentation acceptable to the County of Orange.

B. Small Business Requirements:

1. Must be certified as a Small Business by the State of California Department of General

Services (DGS): and,

2. DGS Small Business requirements must be valid at the time of bid submittal.

5.2 DVBE:

Effective January 1, 2021, County of Orange Board of Supervisors adopted the DVBE Preference policy.

The DVBE Preference policy supports local business opportunity, economy and the development of

County’s tax base, and in addition recognizes the service and sacrifice given by the men and women of our Armed Forces.

To be certified as a Disabled Veteran Business Enterprise by the County of Orange, a business shall meet

(A) and (B) below:

A. Must be certified as a DVBE by the State of California Department of General Services (DGS);

and, B. DGS DVBE requirements must be valid at the time of bid submittal.

To participate as an OCLSB and/or DVBE please read and follow the process outlined in COUNTY OF

ORANGE LOCAL SMALL BUSINESS (OCLSB) AND DISABLED VETERAN BUSINESS

ENTERPRISE (DVBE) CERTIFICATION REQUIREMENTS in the VENDOR RESPONSES.

5.3 OCLSB/DVBE CERTIFICATION REQUIREMENTS:

County Of Orange Local Small Business (OCLSB) Preference And Disabled Veteran Business

Enterprise (DVBE) Certification Requirements

A. To participate as an OCLSB and/or DVBE the following requirements must be met:

1. Must be certified with State of California the Department of General Services (DGS) as a

Small Business - https://caleprocure.ca.gov/pages/sbdvbe-index.aspx

2. Must be certified with DGS as a DVBE - https://caleprocure.ca.gov/pages/sbdvbe-index.aspx

3. maintains their principal center of operations (i.e. headquarters) within Orange County

4. Certification must be valid at the date/time solicitation is closed, and it shall remain in effect at the time of contract award. County reserves the right to verify and/or reject incomplete documents.

5. Complete and sign the Affirmation form attached herein. The signed Affirmation form and the OCLSB Certification are required and must be returned with the solicitation response

B. OCLSB or DVBE Preference provides for the following:

1. Invitation for Bid – IFB

A five percent (5%) deduction in the original bid price shall be applied to all confirmed

OCLSB or DVBE bidders for evaluation purposes. If the lowest bidder is a certified OCLSB or DVBE bidder, the contract will be awarded at the certified OCLSB or DVBE’s original bid price. The maximum allowable preference deduction is $100,000.

2. Request for Proposal - RFP

An additional five percent (5%) shall be applied to the tallied cost score of each certified

OCLSB or DVBE to obtain their final score. If the final score of any OCLSB or DVBE matches the final score of a non-OCLSB or non-DVBE, preference shall be given to the certified OCLSB. If two or more OCLSB or DVBEs have the same final score, the County shall determine the contract award based on the County’s best interest.

C. Dual OCLSB and DVBE Preference provides for the following:

1. Business Certified as OCLSB and DVBE

If a State-certified OCLSB is also a State-certified DVBE, the preference given to that business shall be 8% instead of 5%.

D. Subcontractors

If bidder is submitting subcontractors to qualify for the OCLSB or DVBE preference, bidder must https://caleprocure.ca.gov/pages/sbdvbe-index.aspx https://caleprocure.ca.gov/pages/sbdvbe-index.aspx demonstrate through the Staffing Plan that 20% of the total bid amount is allocated to the OCLSB and/or DVBE subcontractor(s).

*NOTE: DVBE PREFERENCE IS NOT APPLICABLE TO PUBLIC WORKS OR A-E

CONSTRUCTION PROJECTS.

SECTION 6. Electronic Fund Transfer (EFT)

If awarded, the County offers Bidder the option of receiving payment directly to its bank account via an

Electronic Fund Transfer (EFT) process in lieu of a check payment. Payment made via EFT shall also receive an Electronic Remittance Advice with the payment details via e-mail. An e-mail address shall need to be provided to County via an EFT Authorization Form. A copy of the EFT form is attached as an Exhibit to this solicitation.

SECTION 7. Pricing

Line Item Description Quantity Unit of

Measure Unit Cost Total

1 SaaS to Include (Year 1): ● 5 Primary, 10 Secondary Licenses ● 1 Live & 1

Training Database ● 21 CFR Part 11

Technical Controls (includes session time out, audit log, etc.) ● Web

Interface ● Mobile App ● 60GB Data

Storage ● SSO (single sign on) ●

Annual Hosting Costs (AWS) –

ISO27001 ● Upgrades & Patch

Management ● Backups & Business

Continuity Support

1 N/A

2 Review to Include (Year 1): ● 5

Power and 10 Standard Licenses

(Active/Concurrent) ● 21CRF

Compliant ● Review Set Up

1 N/A

3 Support Package (Standard Plan) to

Include (Year 1): ● Support Available

24/7 ● Access to Pooled Customer

Success Managers ● Regular Health

Checks and Adoption Goal Review

Services ● Access to Remote

Customer Events & Knowledge Base

Access to E-Learning

1 N/A

4 Professional Services to Include (Year

1): ● Reconfiguration and Training

Services of all Modules

25 Days

Line Item Description Quantity Unit of

Measure Unit Cost Total

5 Implementation Service (Year 1) –

Days Required for Staged Deployment

Upgrade and Migration to Saas. (Inc.

UAT Period)

2 Days

6 Total For Year Two of Maintenance 1 EA

7 Total for Year Three of Maintenance 1 EA

8 Total for Year Four of Maintenance 1 EA

9 Total for Year Five of Maintenance 1 EA

TOTAL

SECTION 8. Vendor Responses

8.1 BID VALIDITY: *

Bids will be valid for a period of 365 days after the solicitation closing date.

☐ Please confirm

*Response required

8.2 CONTRACTOR INFORMATION

8.2.1 Name of Bidder*

Please state the Name of Bidder here.

If Bidder is a corporation, the legal name of the corporation shall be set forth in this section as the Name of Bidder and the name, title, and person authorized to sign contracts on behalf of the corporation shall be stated as well.

If Bidder is a partnership or joint venture, the true name of the firm shall be set forth as the Name of

Bidder and the name of the partner authorized to sign contracts on behalf of the partnership or joint venture shall be stated as well.

If submittal of this bid or signature of any document submitted with this bid is by an agent other than an officer of a corporation or a member of a partnership, a Power of Attorney must be on file with County prior to Bid opening, or must be submitted with the Bid; otherwise, the Bid may be rejected as non-responsive. You may upload this power of attorney under Additional Information later in this bid response.

*Response required

8.3 COMPANY PROFILE & REFERENCES

8.3.1 Company Legal Name*

*Response required

8.3.2 Company Legal Status*

Please state the status here (Corporation, Partnership, Sole Proprietor, etc.)

*Response required

8.3.3 Corporate Office Address*

What is the address of the company's corporate office? Please provide the full street/mailing address.

*Response required

8.3.4 Local Business Address(es)*

Please provide the local business address for the company named above. If there are multiple local addresses then please provide all.

• Full address:

• Telephone Number:

• E-mail Address:

*Response required

8.3.5 Length of Time Firm Has Been In Business*

Please clearly state, in months and years, how long your firm has been in business.

*Response required

8.3.6 Length of Time At Current Location*

Please clearly state, in months and years, how long your firm has been in business at its current location.

*Response required

8.3.7 Regular Business Hours*

*Response required

8.3.8 Regular Holidays and Hours When Business Is Closed*

*Response required

8.3.9 Federal Taxpayer ID Number*

*Response required

8.3.10 DUNS Number*

Please provide your D-U-N-S Number

*Response required

8.3.11 Unique Entity Identifier Number (UEI)*

The County requires a valid UEI number with active registration status. Your company may obtain one at no cost at https://sam.gov/entity-registration.

*Response required https://sam.gov/entity-registration

8.3.12 Are you registered, active, and in good standing with the California Secretary of

State?*

☐ Yes

☐ No

*Response required

8.3.13 Corporation?*

Is your firm incorporated?

☐ Yes

☐ No

*Response required

When equals "Yes"

8.3.14 State of Incorporation?*

You have indicated that your firm is incorporated. Please provide the name of the State of

Incorporation.

*Response required

When equals "Yes"

8.3.15 Contract Signature Authority - Executive Signature*

If incorporated, please provide the name, contact number, and email of the person who would provide this signature authority. The Executive Signer Authority comes from the President, Vice-President, or

Chairperson of the Board.

• Contact Full Name:

• Contact Number:

• E-mail Address:

*Response required

When equals "Yes"

8.3.16 Contract Signature Authority - Financial Signature*

If incorporated, please provide the name, contact number, and email of the person who would provide this signature authority. The Financial Signer Authority comes from the Secretary, Assistant

Secretary, Chief Financial Officer, or Treasurer.

• Contact Full Name:

• Contact Number:

• E-mail Address:

When equals "No"

8.3.17 Contract Signature Authority*

If not incorporated, please provide the name, contact number, and email of the person who has the binding and signature authority of this contract.

• Contact Full Name:

• Contact Title:

• Contact Number:

• E-mail Address:

*Response required

8.3.18 Sole Proprietor Under Different Name?*

Is your firm a sole proprietor doing business under a different name?

☐ Yes

☐ No

*Response required

When equals "Yes"

8.3.19 Sole Proprietor's Name*

You have indicated that your firm is a sole proprietorship doing business under a different name.

Please provide the sole proprietor's name and the name you are doing business under.

*Response required

8.3.20 Contact Person for Solicitation*

Please provide the following in relation to the point of contact for this solicitation:

• Contact Person Full Name

• Contact Person Telephone Number

• Contact Person Email Address

*Response required

8.3.21 Project Manager*

Please provide the following regarding who will be your project manager for this project:

• Project Manager Full Name

• Project Manager Telephone Number

• Project Manager Email Address

8.3.22 Contact Person for Accounting*

Please provide the following in relation to the point of contact for Accounting:

• Contact Person Full Name

• Contact Person Telephone Number

• Contact Person Email Address

*Response required

8.3.23 Emergency Contact*

In the event of an emergency of declared disaster, the following is required:

• Contact Person Full Name (during non-business hours)

• Contact Person Telephone/Cellphone Number

• Contact Person Email Address

*Response required

8.4 BIDDER CERTIFICATION

8.4.1 Conflict of Interest*

Bidder must certify either Yes or No below:

Bidder certifies current/past…