RFI instruction and attachement.pdf

Request for Information (RFI) Instructions

1. Background:

This is Sources Sought Request for Information (RFI) to identify potential small businesses who are interested and capable to meet Food and Drug Administration’s requirements of seeking Commercial Off-the-Shelf software licenses and professional IT services to enhance and support the current Quality Management Information System (QMiS) iterations in Office of Pharmaceutical Quality (OPQ), both laboratory based and non-laboratory based, as well as merge the two systems and transition to the Cloud environment. Please review Attachment 1 – Draft Statement of Work for detail information on the requirements.

2. General Instructions:

This RFI is for information, planning and market research purposes only and shall not be construed as either a solicitation or obligation on the part of FDA or its Centers.

FDA welcomes responses from all interested small businesses to submit a response to this RFI. FDA does not intend to make a selection decision or award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or FDA's

Additionally, the FDA does not intend to hold discussions concerning this RFI with any interested parties. However, FDA reserves the right to contact vendors if additional information is required.

A complete response to the RFI should include answers to all of the questions below. Please note that a respondent's failure to provide a complete response to a question will be interpreted to mean that it does not understand the question and does not demonstrate the capability to provide services required. Responses should demonstrate capability, not merely affirm the respondent's capability (e.g.: The response must go beyond the statement that, "XYZ company can provide Material characterization and Analysis Services.").

The RFI responses should be submitted via email to Min Jie Zeng at minjie.zeng@fda.hhs.gov and Lilibeth Deato at Lilibeth.Deato@fda.hhs.gov by 4PM ET on

July 22, 2024. E-Mail is the only acceptable method of delivery for this notice of sources sought.

3. Questions:

1) On the FACE PAGE of your response, please provide the following:

a. Organization name

b. DUNS number

c. Organization's website

d. Contact Name

e. Contact Telephone

f. Contact E-mail address

g. Size designation and type (i.e. Small Business, etc)

h. Number of employees in your organization

i. Your organization's current and gross revenue

j. Current GSA Federal Supply Schedule number

2) Elaborate previous experience on performing similar types of tasks specified in Attachment 1 – Draft Statement of Work. The elaboration on each experience shall include:

a. Evidence of performing the similar types of tasks, including but not limited to the contract number, period of performance, and the Government or private entity customer POC.

b. Brief introduction of the project’s objective and scope.

c. Brief description of the methodology and equipment used to perform the similar types of tasks.

3) Do any gaps exist in the Draft Statement of Works? If so, what are they? What changes, additions, updates, and clarifications would you suggest?

4) What is the NAICS code would you suggest use for this requirement?

5) What contract type would you recommend to use for this requirement?

4. Attachments:

Attachment 1 – Draft Statement of Work

QMiS for FDA Statement of Work

Food and Drug Administration

Quality Management Information System (QMiS)

Draft Statement of Work

1 INTRODUCTION AND OBJECTIVES

This Statement of Work (SOW) is for Software and Services to support the enhancement and maintenance of a Quality Management Information System (QMiS) for the Office of Pharmaceutical Quality within the Food and Drug Administration (FDA) to ensure compliance with FDA Standard Manual Guide (SMG) 2020, FDA

Quality System Framework for Internal Activities.

The purpose of this initiative is to:

Promote standardization

Improve process consistency

Increase efficiency

Provide a comprehensive approach to quality and compliance by continuing to operate with:

Commercial off-the-shelf (COTS) QMiS software known as MasterControl that can interoperate and scale to support OPQ

Professional services to configure, deploy, train, validate, migrate existing documents, and support FDA’s use and adoption of the QMiS.

Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the

Government, as needed to perform this Statement of Work.

2 BACKGROUND

As part of a future CDER wide effort, OPQ has implemented a Quality Management System (QMS). A QMS provides a framework for critical elements (e.g., document control, training, non-conformance management, auditing, etc.) in managing our core processes. This framework enhances our ability to assure the availability of quality medicines. A QMS allows for data-driven decisions to improve our effectiveness and efficiencies of our assessments and processes. With the increasing requirements being established by our user fee programs, it is crucial to have a QMS that provides:

1. Consistent Work Products

2. Customer Satisfaction

3. Continual Improvement

For OPQ, the QMS governs the core processes (Assessment, Surveillance, Research, Policy, Inspection) within the office. A QMS aids in establishing the standards for our products and process, and these standards are documented in policy documents, MaPPs, SOPs, etc. Through an effective training program, a QMS ensures the staff are well-equipped to perform their duties as defined, thus minimizing deviations. A QMS is responsible for monitoring products and processes as well as initiating improvements/changes when data indicates the need.

Most changes and improvements made to our processes are driven by qualitative information. A QMS provides more quantitative information (e.g., # of times a non-conformance occurred in the past 6 months). This allows OPQ to identify issues more quickly, and to focus our resources on the areas of improvement having the most impact (e.g., area with highest number of deviations/non-conformances).

OPQ has nearly completed implementation of their QMS, however, there are many elements of a QMS to manage and more improvements to make. Thus, full implementation has not been realized to date.

2.3 CURRENT STATE

Currently OPQ uses MasterControl as a centralized system for managing QMS including key QMS pillars such as document management, change control, training corrective and preventative actions, and process audits. Management Review and Management of Change will be included in future enhancements.

OPQ is also undergoing a reorganization in 2024. This reorganization will require heavy updates to the

QMiS as well as merging the OPQ instance of MasterControl with the lab-based MasterControl iteration used by our St. Louis laboratory for over 8 years.

3 SCOPE

The scope of this procurement is to acquire Commercial Off-the-Shelf software licenses and professional IT services to enhance and support the current QMiS iterations in OPQ, both laboratory based and non-laboratory based, as well as merge the two systems and transition to the Cloud environment. The system is built for use by OPQ that can be expanded for us by other CDER offices in the future. For OPQ, the QMS governs the core processes (Assessment, Surveillance, Research, Policy, Inspection) within the office, and will be used by all staff (approx. 1400) when fully implemented.

4 SOFTWARE REQUIREMENTS

4.1 GENERAL USER REQUIREMENTS

4.1.1 Licenses

The Contractor shall provide:

1. Licenses must be provided for MasterControl software, or equal capable of supporting OPQ processes and expandable for other CDER offices.

2. Licensing can be broken down into administrative licensing used by those that manage the QMiS and basic user licenses for those that simply create documents, take training and submit Events for the CAPA system.

3. A System with no dependencies, restrictions, or limitations on the number of documents, workflows, or other entities managed by the System.

4. Licenses must be offered in increments with discounts increasing along with total license count.

OPQ expects the total license count to increase to approximately 1400 within two years. Many organizations within the FDA use MasterControl so a large group discount is preferred rather than license discount based on OPQ number of licenses specifically.

5. Licenses must not be required for:

a. FDA System Administrators and helpdesk support staff

b. Development, Validation, or Training environments

6. Licenses and support periods of performance will become effective and payment will be due upon FDA’s acceptance of the System Release Memo.

4.1.2 General

The Contractor shall provide a System that must:

1. MasterControl software capable of continuing OPQ QMS operations and potentially supporting other CDER offices.

2. Provide FDA administrators with the ability to logically partition the organizational, procedural, process, and functional elements of the System.

3. Be accessible from within and external to the FDA network by employees and partners for a variety of tasks and user types.

4. Support integration with appropriate FDA systems to permit single-sign-on for FDA staff.

5. Support role-based access and permission management.

6. Support role-based access to all functions and workflows.

7. Include security features to restrict and report unauthorized access attempts.

8. Maintain audit logs of all system activity and document changes.

9. Support configurable metadata and naming conventions per FDA.

10. Fully support current and new versions of Windows and Macintosh operating systems.

11. Fully support current and new versions of Google Chrome on Windows and Macintosh, and

Apple Safari, Microsoft Edge, and Microsoft Internet Explorer on their respective operating systems.

12. Be Section 508 compliant (See Sec 8 Privacy and Security), in a way that is efficient to develop, implement, test, and use by all members of the FDA user community.

13. Be offered as cloud-hosted solution to be installed on FDA-gov cloud which is Federal Risk and

Authorization Management Program (FedRAMP) certified. Systems designed to be installed on premise at FDA facility will not be considered.

14. Be Federal Information Security Management Act (FISMA) Moderate compliant. FISMA certification will be required prior to placing the system in production use.

15. Include fully functional quality assurance (QA) and training (TRN) environments that are configured identically to the production (PROD) environment.

4.1.3 Electronic Signatures

The Contractor shall provide a System which supports electronic signatures that meet the necessary regulatory requirements, in particular 21 CFR Part 11 for electronic records, for all document approvals and procedural affirmations.

4.1.4 Document Management System

The Contractor must assist with improvements to the common document management platform that supports:

1. Drafting of new documents with change control while drafting.

2. Automatic versioning.

3. Generation of certified copies.

4. Full text search with stemming, wildcarding, and Boolean options.

5. Document searches based on keyword, FDA defined metadata, user roles, document status, process, and workflow activity.

6. Various file formats (Word, SAS, Excel, JPEG, PDF, etc.).

7. Automatic maintenance of relationships between different renditions of the same document

(e.g. MS Word and PDF).

4.1.5 Administration

The Contractor shall provide a System which must be configurable such that FDA administrators can:

1. Create, manage, and modify workflows.

2. Create, manage, and modify metadata and naming conventions.

3. Create, manage, and modify user roles and access permissions.

4. Generate and export detailed audit and usage reports.

4.1.6 Computer Systems Validation (CSV) Support

The Contractor shall provide a System which must be delivered with a Computer Systems Validation (CSV) package that provides documented evidence of compliance with regulatory requirements including 21 CFR part 11, ICH E6 (R2), and GAMP 5 (or similar risk-based framework). CSV packages must be provided for the initial deployment and for any subsequent upgrades. At a minimum, the CSV package must include:

1. Documentation of System features supporting 21 CFR part 11, particularly electronic signatures.

2. Installation Qualification (IQ) and Operational Qualification (OQ) artifacts such as IQ Plan, OQ

Plan, executed test scripts, and summary reports.

3. Exemplar Performance Qualification (PQ) Plan and PQ test scripts that FDA can adapt to meet its specific requirements.

4. Any Standard Operating Procedures (SOPS) referenced by the qualification plans.

4.2 QMS FUNCTIONAL REQUIREMENTS

The Contractor shall provide the MasterControl, or equal, that meets the following criteria. A solution other than MasterControl shall prove in writing to be equivalent to MasterControl and met all requirements below.

4.3.1 General

The following requirements shall be satisfied in all QMiS functional areas:

1. Provide process workflows to be configured to meet the different business needs of FDA.

2. Automate the entire lifecycle of all quality related documents such as guidelines, policies, procedures, standard operating procedures (SOPs), and work instructions. The lifecycle includes creation, review, approval, revision, dissemination, and obsolescence.

3. Shall have an automated revision control to ensure that the current version of a document is available by default and that prior versions can be easily accessed on demand.

4. Shall automatically create PDF renditions of all non-PDF documents.

5. Support customized naming conventions, numbering, and formatting of quality related documents.

6. Manage quality processes, such as assessments, audits, Corrective and Preventative Actions

(CAPAs), change management, customer complaints, deviations, management review, and training.

7. Offer ability to manage laboratory equipment tracking (operating status, OQ/PQ and preventative maintenance scheduling) with the ability to link and deviations or non-conformances regarding equipment to the CAPA element.

8. Enable authorized users and FDA leadership to view – in detail and at a high level – quality related activity, status, history, and resources.

9. Shall generate reports of QMS activities and issues at various levels, to allow review by FDA leadership, and document the oversight of FDA leadership.

4.3.2 Training Management

The Contractor provided QMiS shall include a platform to document and manage training requirements and activities, including:

1. A centralized repository to capture all training documents. Specifically, this repository must be the common document management system.

2. The ability to develop and maintain training assignments for different positions or roles.

3. The ability to track training needs and completed training.

4. The ability to automatically notify employees when training is required due to a change in a SOP or the need for refresher training.

4.3.3 Quality Events

The Contractor provided QMiS shall include functionality for automating and documenting the initiation, management, and reporting quality events such as deviations, Corrective and Preventative Actions (CAPAs), and nonconformance. This includes:

1. The ability to link and cross-reference quality events to other quality related documents such as

SOPs and policies.

2. Automatic generation of alerts.

3. Assignment of milestone dates (e.g. planned completion due dates, follow-up reviews, actual completion dates, and effectiveness checks).

4. Review and approval process workflows.

5. Capture of e-signature, root cause, and investigation processes as appropriate.

6. The ability to track and report on status of all current and historical quality events.

7. The capability for reporting trends to determine possible systemic quality issues.

4.3.4 Change Management

1. The Contractor provided QMiS shall automate change management process steps (initial request, pre-approval, change execution, post-approval) for different types (processes, facilities, products, etc.).

2. The Contractor provided QMiS shall provide options to assess the change management based on risk.

4.3.5 Non-conformances and Deviations

1. The Contractor provided QMiS shall have automated workflow with e-signature to document non-conformances and deviations.

2. The Contractor provided QMiS shall include trending of non-conformances and deviations and reporting capabilities.

5 PROFESSIONAL SERVICES S REQUIREMENTS

The second objective of this procurement is to obtain services to ensure the successful configuration, integration, validation, adoption, and operation of the System. The Contractor must provide these tasks through the professional services arm of the Contractor’s company, a third-party systems integrator, or both.

Professional services deliverables are grouped into two broad categories:

Initial Tasks – These include all the activities needed to configure and evaluate the System.

Ongoing Tasks – These include all the activities needed to support a fully operational System.

5.1 INITIAL TASKS

The Contractor shall work on the following tasks upon contract award. The primary objectives of these tasks are to:

1. Installation of the QMiS on the FDA-government cloud

2. Planning and completion of the merge of 2 MasterControl iterations in OPQ. The St. Louis lab-based system will merge with the OPQ-wide system. The STL system is ISO 17025 accredited and any merge must maintain support that accreditation.

3. Train key FDA project team members and initial users in the capabilities and use of the

System.

4. Development and implementation of Management Review meeting data capture system within QMiS.

5. Implementation of data changes related to OPQ reorganization. Including but not limited to user info, trainee info, vaults, infocard numbering, and JobCodes.

5.1.1 Project Planning Teleconference

Within one week of contract award, the Contractor must participate in a conference call prior to the kickoff meeting to exchange sufficient information to develop an agenda, organize, and prepare questions and discussion topics for the project kickoff meeting, project planning, project team training, System Setup

Workshop, and technical planning sessions.

5.1.2 Project Kickoff Meeting

Within two weeks of contract award key Contractor personnel must participate in an project kickoff meeting with key FDA project team members. The objectives of the meeting are to confirm project objectives, scope, schedule, roles and responsibilities and to review a preliminary project plan.

5.1.3 Software Installation

Within two weeks of the Project Kickoff meeting, the Contractor shall confirm installation of the Software on the FDA-government servers. Once FedRamp Certified, MasterControl is responsible for the installation on the FDA-government cloud environment.

5.1.4 Project Team Training

The Contractor shall provide training to the FDA project team members so they have the knowledge needed manage the System. FDA intends to manage and deliver training to new users after the System is in production use using documentation and materials provided by the Contractor.

1. Contractor shall provide onsite train-the-trainer training for FDA staff on the configuration and use of the System. The purpose of the training is to give the FDA team sufficient understanding and experience of the System so they can participate in other project activities.

2. Any necessary training shall be conducted immediately after the kickoff meeting so that team members have a better understanding of the System before beginning detailed planning activities.

3. The Contractor must provide electronic copies of training materials for all System roles.

4. FDA staff may adapt and incorporate Contractor training materials into FDA training materials for use by any and all licensed users of the System.

5. The Contractor may offer computer-based-training (CBT) options provided it is available to all licensed users and is updated coincident with updates to the System.

5.1.5 System Setup Workshop

Following project team training, the Contractor shall lead one onsite interactive System Setup

Workshop (SSW) with FDA team members. The Contractor shall:

1. Ensure that FDA stakeholders have a full understanding of the System’s capabilities and how they relate to FDA’s needs.

2. Identify and document the specific options, configuration, and functionality that will be made available to FDA users. This includes but is not limited the following:

a. User groups and System roles.

b. Process mapping and workflows.

c. Metadata and naming conventions.

d. Document templates.

e. System notifications (emails) and alerts.

f. Reports, dashboards, and Key Performance Indicators (KPIs).

5.1.6 Final Project Plan

Using information collected during the kickoff meeting and SSW, the Contractor shall create and deliver the

Project Plan with two weeks after the kickoff meeting. The project plan shall identify schedules, deliverables, and responsible parties for all project tasks and activities.

5.1.7 Technical Planning Sessions

Within two weeks of contract award and on an as-needed basis, the Contractor shall participate in technical planning sessions with FDA staff. The primary objectives of these meetings will be to ensure that FDA technical and information security has sufficient information needed to ensure that the technical and operational aspects of the System satisfy requirements.

5.1.8 Quality Assurance/System Validation

The Contractor shall provide and review with FDA staff all relevant IQ and OQ Plans, test scripts, and summary reports.

The Contractor shall provide an exemplar PQ Plan and PQ Test Scripts and assist FDA staff in revising and tailoring the PQ Plan and PQ Test Scripts to satisfy FDA requirements.

5.1.9 Pilot Evaluation

Because the initial installation has been completed for both iterations, a true pilot phase is not need.

However, based on the input from the SSW, the Contractor shall configure the QMiS software and provide guidance and assistance needed to enable FDA to conduct a 4-month pilot of the System both after the two systems are merged and after transfer to the Cloud. The purpose of the pilot is to refine the Institute’s needs as well as the configuration of the System.

5.1.10 Initial Production Deployment

The Contractor shall deploy and make available the QA environment for FDA to conduct PQ. Upon successful completion of PQ, the Contractor must deploy the production and training environments and issue the System Release Memo. The training and production environments have already been built.

The Contractor shall provide technical support to complete the Certification and Accreditation (C&A) of any additions or enhancements to the existing MasterControl system, as well as ongoing support to obtain the

System’s Authorization to Operate (ATO) for the St. Louis iteration of MasterControl while awaiting the merge of the two systems. This will include:

1. Completing FISMA requirements and documentation conforming to National Institute of

Standards and Technology (NIST) guidelines such as, but limited to, security controls (NIST SP

800-53), configuration management, business continuity, and incident response.

2. Identification of monitoring, vulnerability scanning and assessment tools.

3. Documentation describing risk identification, management, and mitigation procedures and policies.

5.1.11 Data Migration

The Contractor shall transfer existing data and documents into the QMiS system. This includes but is not limited to the following tasks:

Depending on how the two iterations of MasterControl are merged, all data will need to be transferred into one iteration of MasterControl.

Transfer of SOPs/documents from file shares or document management systems that have not yet been entered.

Transfer of data/documents into Equipment module, CAPA modules and other modules as needed.

All quality assurance and control processes needed to ensure that all migrated documents and data maintain compliance with regulatory requirements.

5.2 ONGOING TASKS

The following tasks and deliverables primarily apply to the operation and support of the production use of the System throughout the period of performance.

5.2.1 Administrative

The Contractor’s Project Manager (PM) shall participate in regular teleconference status meetings (no less frequently than once a month) to review System activity, utilization, billings, issues, and future plans.

Onsite meetings will be scheduled on an ad hoc basis as needed.

5.2.2 Training & Documentation

The Contractor shall provide updated end-user training and documentation whenever there are new or significant changes to System functionality.

5.2.3 Operations

The Contractor shall be responsible for all backups, restores, disaster planning and recovery, patching, and server monitoring and provisioning.

The Contractor’s SOPs, procedures, and other relevant documentation for these activities shall be provided during the initiation phase of the project and whenever significantly changed. Regular reports and logs demonstrating compliance with these requirements must be provided no less than monthly.

The Contractor shall provide technical support to maintain the Certification and Accreditation (C&A) of the

System, as well as ongoing support to maintain the System’s Authority to Operate (ATO). Tasks will include:

1. Updating security controls (NIST SP 800-53) as necessary.

2. Conducting periodic System security scans and submitting the results to FDA.

3. Proactive monitoring, identification, and mitigation of security vulnerabilities – including any vulnerabilities reported by FDA.

4. Notify the Government of System breaches, compromises, or data losses within 4 hours of detection.

5. Remedial action must be taken to address security vulnerabilities within the following timeframes:

a. Critical – 2 days

b. Severe – 4 days

c. Serious – 7 days

5.2.4 Support, Service Level Agreement (SLA) and Communication

1. The Contractor shall provide service level agreement that provides a definition for grading the severity of issues and timing expectation for the Contractor’s response based on the severity level of the issue. FDA expects the following issue response times:

Issue

Level

Impact Examples Maximum

Response Time to

Confirm Issue with

FDA

Maximum Time to Resolve the

Issue

Critical The issue is a major application problem making it impossible to use the System.

Service is not available;

application does not save critical data correctly

4 business hours 1 business day

High The issue impacts a large number of users and no work around exists.

Slow application response time, session timeouts, some application functionality is broken

1 business day 2 business days

Medium The issue impacts a small number of users of a particular user role, or large number of broad users.

However, a workaround does exist.

Users running a supported browser are impacted but can use an alternate browser.

Minor function is broken, but workflow can still proceed.

2 business days 4 business days

Low The issue does not impact the users.

A new feature request, or the issue is minor and does not impact workflow.

5 business days N/A

2. The Contractor shall provide first level support via email and a 24/5 toll-free helpdesk for routine end-user issues such as:

a. The authorization, addition, removal, and modification of user access using criteria and within a timeframe specified by FDA.

b. Access problems.

c. System functionality and usage.

d. Enhancement requests.

3. The Contractor shall notify users and FDA administrators at least 24 hours in advance of any planned outage and its expected duration.

4. Within one hour of the occurrence of an unplanned outage, the Contractor shall notify users and FDA administrators of the issue and an anticipated resolution time. Thereafter, updates must be provided no less frequently than every four hours until the issue is resolved.

5. The Contractor shall provide FDA administrators with direct access to qualified technical experts via email and a 24/5 toll-free helpdesk.

6. On an as-needed basis the Contractor shall make qualified technical staff available on status calls to review and discuss identified issues.

7. The Contractor shall provide monthly operational reports summarizing updates, usage, outages, issues, and response times.

8. The Contractor shall provide contact information for the corporate executives responsible for all professional services and operations. These executives will be contacted to escalate critical issues in the event normal processes are not working.

5.2.5 Updates

The Contractor shall provide:

1. System and software updates and patches required to address regulatory changes must be implemented at least one month in advance of the regulatory effective date.

2. Updated training material and user documentation must be delivered at least one month in advance of any implemented change.

3. An updated CSV package must be delivered at least one month in advance of any implemented change.

4. Provide Installation Qualification and Operational Qualification (IQ/OQ) testing and supporting documentation for all System upgrades.

5.2.6 Transition-out or Termination

No later than 45 days prior to end of the contract period of performance (POP) or within 5 days notification that FDA intends to terminate the contract, the Contractor must prepare and deliver a detailed transition plan. During the transition period, the incumbent Contractor shall provide all resources required to ensure a smooth transition to the successor Contractor. This includes a validated transfer of all documents and data.

FDA requires the maintenance of all customer support during this period. All performance requirements of the contract will remain in effect until contract term as defined expires.

At no time and under no circumstances shall the Contractor withhold or render inaccessible any FDA documents or data.

5.3 OPTIONAL TASKS

The following optional task may be exercised at FDA’s discretion during the period of performance in accordance with FAR 52.217-7 Option for Increased Quantity – Separately Priced Line Item.

5.3.1 Subject Matter Expert Hours (Optional)

Upon exercise of this option, the Contractor shall provide ad hoc subject matter expertise that includes but is not limited to the following:

Identifying and supporting the implementation of QMiS best practices.

Adapting and reconfiguring the QMiS system in support of evolving regulatory requirements.

Providing analysis and recommendations in support of unusual or unexpected out-of-scope operational issues and opportunities.

6 PLACE OF PERFORMANCE

Any onsite activities requested in this SOW must be performed at:

10903 New Hampshire Avenue, Silver Spring, MD 20993.

7 DELIVERABLES/DELIVERY SCHEDULE

Key deliverables to FDA are summarized in the following table.

Deliverable Description Due By

5.1.1 Project Planning

Teleconference

Initial planning session between the Contractor and

FDA stakeholders.

1 week after award

5.1.2 Kick Off Meeting Confirm project objectives, scope, schedule, roles and responsibilities and to review a preliminary project plan.

2 weeks after award

5.1.3 Software

Installation

Confirm installation of Software on the FDA-government servers

2 weeks after

Kickoff

Meeting

4 Project Team Training Onsite training for FDA staff on the configuration and use of the System as needed.

TBD

4 Training Materials, User and Administrator

Documentation

Electronic copies of all relevant materials and documentation.

TBD

5 System Setup

Workshop

Ensure that FDA stakeholders have a full understanding of the System’s capabilities and how they relate to FDA’s needs.

Identify and document the specific options, configuration, and functionality that will be made available to FDA users.

TBD

6 Final Project Plan The Contractor must provide a written plan which details the Contractor’s processes and plan for meeting the execution (go-live) timeline established below. The government will have five (5) business days to review and approve the plan.

1 week after SSW

5.1.7 Technical Planning

Sessions

Detailed technical discussions between Contractor staff and FDA administrators.

As-needed

4.1.8 Quality

Documentation and

Consultation

IQ Plans, OQ Plans, executed IQ Test Script, executed

OQ Test Scripts, IQ Summary Report, OQ Summary

Report, exemplar PQ Plan and PQ Test Scripts.

Review with FDA staff as required.

TBD

5.1.9 Pilot System QMiS software, guidance and assistance, for a 6-month pilot evaluation of the System.

TBD

5.1109 System

Release Memo

Certification that the system operates as expected according to the requirements and design specifications and performs reproducibly and consistently throughout all specified operating ranges.

TBD

5.1.10 Authorization

to Operation (ATO)

Culmination of the FISMA required security authorization process required to operate an information technology system in the US federal government. Based on a risk-based assessment documented in a security plan.

Coincident with the System Release

Memo

5.1.11 Data

Migration

(A) Transfer existing data/documentation into the the merged QMiS iteration (B) Transfer existing data/documentation into the Cloud.

TBD

Deliverable Description Due By

4.1.1 Software Licenses Initial licenses have already been distributed.

Additional licenses or transferred licenses should be included.

Initial Production

Deployment

5.2.5 Support contact

information

Helpdesk telephone number and email addresses.

Technical contact telephone number and email addresses.

1 week prior to initial production deployment.

5.2.7 Transition Plan Deliver transition Plan 45 days prior to contract end or within 5 days upon notification

5.2.7 Final Handoff Deliver all software, documentation, datafiles, database and reports to the Government or to new

Contractor.

Last day of the contract.