W81XWH-21-R-0023.docx

W81XWH21R0023

Section SF 1449 - CONTINUATION SHEET

PERFORMANCE WORK STATEMENT

Performance Work Statement (PWS)

Agency/Activity: Enterprise Information Technology Project Management Office (eIT PMO)

Title: eCTD Software License, Maintenance, Technical Support Services, and Training for eCTD Publishing and Reviewing Software products and modules.

1.0 SCOPE / DESCRIPTION OF SERVICE

The eIT PMO needs to acquire software licenses and maintenance for (12) eCTD Publisher user accounts and up to (50) named eCTD reviewer accounts. Additional services required are Technical support services for resolving application problems, training services for both the eCTD publishing and reviewing users, FDA Validated software installation support and scripts, and consulting services to support regulatory questions by the eCTD publishing.

The eCTD software shall be capable of interfacing with OpenText Content Server 10.5 and current releases. The eCTD software must support Microsoft Windows 2012 R2 (64-bit) operating system and newer. This is a designated go, no-go requirement under RFP Technical Approach.

The eCTD software shall also meet U.S. Food & Drug Administration (FDA) 21 CFR Part 11 requirements. This is a designated go, no-go requirement under RFP Technical Approach.

The eCTD Software shall be able to be installed on premise and in the cloud. This is a designated go, no-go requirement under the RFP Technical Approach.

The eCTD system will be managed and maintained by the USAMRDC eIT PMO.

The technical support services must include supporting the migration of existing eCTD submissions and their full lifecycles from the existing eCTD publishing system. This software is also part of a suite of FDA compliant products maintained by the eIT PMO.

The eCTD software must be able to be installed and configured in accordance with cybersecurity best practices in order to reside on the DoD network. The vendor providing the software license and maintenance must support the government with any technical application modifications to ensure the government can receive a Risk Management Framework (RMF) Authority to Operate (ATO).

Directive: FDA compliant software products used for clinical trial research must support the stringent security controls and compliance with U.S. Food & Drug Administration (FDA) 21 CFR Part 11 electronic records and signature requirements.

2.0 TASKS

2.1 Task Management

The Contractor shall provide sufficient management to ensure that this task is performed efficiently, accurately, on time, and in compliance with the requirements of this document. Specifically, the Contractor shall designate a program manager to oversee this task and supervise staff assigned to this task. The Contractor shall ensure that a Monthly Progress Report is submitted outlining the expenditures, billings, progress, status, and any problems/ issues encountered in the performance of this task.

2.1.1 Monthly Progress Report (MPR) – Deliverable 2

The Contractor shall ensure that a MPR (Deliverable 2) is submitted outlining the expenditures, billings, progress, status, and any problems/ issues encountered in the performance of this task. Initial MPR is due NLT 45 days after contract award and NLT the 15th of each month thereafter.

The MPR shall include the labor hours expended, by labor category, for each task and sub-task.

The MPR shall provide status on any communications support provided by the Contractor, to include, but not limited to press releases, inputs to the J-9’s Significant Events report.

The MPR shall include information to update MRDC’s Organization Charts for the Contractor and its subcontractors. This will require coordination with the contractor, who is responsible for producing and updating the official MRDC organizational chart.

Burn rates and total charges for labor and other direct costs (ODC’s) need to be included in the MPR and reflect any additional charges that affect the total amount invoiced, such as fringe benefits, overhead and General and Administrative (G&A) charges.

The Contractor shall require all subcontractors to provide input to the MPR where there are critical or significant tasks related to the prime contract. Critical or significant tasks shall be defined by mutual agreement between the Government and Contractor.

2.1.2 Subcontractor Expenditures Plan – Deliverable 3

The Contractor shall prepare and deliver a Subcontract Expenditures Report (Deliverable 3) that discloses actual subcontract expenditures by company name, business size standard (i.e. Woman Owned Business, Veteran Owned Business, etc.), and other socioeconomic programs (i.e. Indian Incentive Program, Historically Black Colleges and Universities and Minority Institutions, etc.).

2.1.3 Management Plan – Deliverable 4

The Contractor shall develop a Management Plan (Deliverable 4) that shall require Government approval. It will be used to manage, track and evaluate the Contractor’s performance. The Management Plan shall consist of control policies and procedures in accordance with standard industry practices for project administration, execution and tracking. A draft Management Plan will be submitted with offeror’s proposal.

The Management Plan shall include the following:

· Identification of milestones where Government information/activity is required and timeline dependencies for subsequent Contractor activities;

· An Integrated Master Management Plan (IMMP) describing the Contractor’s overall management approaches, policies and procedures including suggested project metrics; and,

· A detailed staffing plan.

The final Management Plan shall be due five (5) calendar days after the start of the contract and updated as required.

2.1.4 Quality Control Plan – Deliverable 5

The Contractor shall prepare and adhere to a Quality Control Plan (QCP). A QCP will initially be submitted NLT 30 DACA (Deliverable 5). The QCP shall document how the Contractor will meet and comply with the quality standards established in this statement of work. At a minimum, the QCP must include a self-inspection plan, an internal staffing plan, and an outline of the procedures that the Contractor will use to maintain quality, timeliness, responsiveness, and customer satisfaction. After acceptance of the quality control plan the contractor shall receive the contracting officer’s acceptance in writing of any proposed change to their QCP system. This plan must be specific to the requirement as outlined.

2.1.5 Contingency Operations Plan – Deliverable 6

The Contractor shall prepare and submit a Contingency Operations Plan (COP) to the Government. The COP shall be due ten (10) calendar days after the award of the contract, and shall be updated on a quarterly basis (Deliverable 6). The COP shall document Contractor’s plans and procedures to maintain eIT PMO support during an emergency. The Contingency Operations Plan shall include the following:

· A description of the Contractor’s emergency management procedures and policy

· A description of how the Contractor will account for their employees during an emergency

· Planned temporary work locations or alternate facilities

· How the Contractor will communicate with eIT PMO during emergencies

· A list of primary and alternate Contractor points of contact, each with primary and alternate:

· Telephone numbers

· E-mail addresses

· Procedures for protecting Government furnished equipment (if any)

· Procedures for safeguarding sensitive and/or classified Government information (if applicable)

2.1.6 Operations During Emergency Situations

Individual contingency operation plans shall be activated immediately after determining that an emergency has occurred, shall be operational within twelve (12) hours of activation, and shall be sustainable until the emergency situation is resolved and normal conditions are restored or the contract is terminated, whichever comes first. In case of a life threatening emergency, the COR will immediately make contact with the Contractor Task Managers to ascertain the status of any Contractor personnel who were located in Government controlled space affected by the emergency. When any disruption of normal, daily operations occur, the Contractor Task Manager shall promptly open an effective means of communication with the COR and verify:

· Key points of contact (Government and Contractor)

· Temporary work locations (alternate office spaces, telework, virtual offices, etc.)

· Means of communication available under the circumstances (e.g. email, webmail, telephone, FAX, courier, etc.)

· Essential work products expected to continue production by priority

The Contractor Task Manager, in coordination with the COR, shall make use of the resources and tools available to continue eIT PMO contracted functions to the maximum extent possible under emergency circumstances. Regardless of contract type, and of work location, Contractors performing work in support of authorized tasks within the scope of their contract shall charge those hours accurately in accordance with the terms of this contract.

2.1.7 Identification of Contractor Personnel: All contract personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed. All contractor personnel will be required to obtain and wear badges in the performance of this service.

2.1.8 Contracting Officer Representative (COR): The COR will be identified by separate letter. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions in addition to what is outlined in the designation letter: assure that the Contractor performs the technical requirements of the contract: perform inspections necessary in connection with contract performance: maintain written and oral communications with the Contractor concerning technical aspects of the contract: issue written interpretations of technical requirements, including Government drawings, designs, specifications: monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies; coordinate availability of Government furnished property, and provide site entry of Contractor personnel. A letter of designation will be issued to the COR and a copy of which is sent to the Contractor, stating the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.

2.2 Specific Tasks

Task 1: Software Maintenance (FFP) The contractor shall provide software licenses and maintenance for the number of licenses listed below:

(12) eCTD Publishing User Licenses

(50) eCTD Reviewing User Licenses (concurrent users)

Licensing shall also include:

· The ability to perform linking within the publishing application

· The ability to do submission validation

· Validation Test scripts for the initial version and future versions of both eCTD Publishing software and eCTD Reviewing software.

The contractor shall provide a cost to add licenses over the course of the contract, (see Task 5). The increase during each POP shall not exceed 5 Publishing user Licenses and 15 Viewing licenses in a contract year. This is to allow for flexibility should the end user base increase. Software license maintenance must maintain the following functions:

1. eCTD Publishing

1. eCTD Submission Validation

1. eCTD Viewing (See PWS Attachment A for a full list of software system requirements)

(See Attachment B for the Quality Assurance and Surveillance Plan (QASP) for maintenance requirements)

Task 2: Consulting and Technical Support Services (Reimbursable) Consulting and Technical Support services requested shall include:

Standard eCTD Software Project Management:

The contractor shall work collaboratively with the eIT PMO staff on remediation of network security vulnerabilities discovered during evaluation testing in order to achieve a secure software installation which is required to maintain the software on a DoD network. The contractor shall provide necessary support and communication to schedule and provide all services.

Technical and Regulatory Consulting:

The contractor shall provide technical support for installation, upgrade, and validation support for all software maintained under this contract on an as needed basis. Technical support services are required for but not limited to:

1. Project Management

1. Regulatory Consulting

1. Installation of eCTD software products

1. Pre-installation and installation testing

1. Validation support- scripts included

1. eCTD Software Upgrade Support

Installation, Testing, Configuration, Migration, Validation, etc.:

The contractor shall work collaboratively with eIT PMO staff on the installation, configuration, upgrades and data migration of eCTD software products, modules, and data into two computing environments (test and production) in a datacenter or in a cloud environment. This will include the development/modification of installation instructions to allow the products to function within the parameters specified for Department of Defense installations.

The contractor shall provide technical support and documentation for testing and validation of the products. Documents to be generated, authored/updated, and provided shall include the following on an as needed basis:

0. Master Validation Plan (MVP)

0. Design Specifications

0. Validation Test Plan for Installation Qualification (IQ) based on vendor provided templates

0. Validation source book for Installation Qualification (IQ)/Operational Qualification (OQ)/Performance Qualification (PQ)

0. Modification of standard IQ test scripts for eIT PMO installation

0. System Configuration guide

0. Work instructions and process flow

0. Documents should be provided in Microsoft Word format and be updated for the software version being supported.

Task 3: Training (Reimbursable) Request a menu of trainings available to successfully train and support end users for the following software products.

· eCTD Publisher

· eCTD Reviewer The contractor shall provide live onsite or virtual training and training documentation to eIT PMO product administrators, advanced users and general users to support all products and modules delivered under this PWS. The contractor shall provide a list of training available with costs and cost of all training materials. Training courses shall include but may not be limited to:

Standard eCTD Publisher Training

Advanced eCTD Publisher Training

Administrator Training eCTD Reviewer Training

Training materials shipping expense (if required)

See PWS Section 5 (Training ODCs)

Task 4: Travel (Reimbursable) Travel cost estimate for in-person trainings or for technical consulting support held at Fort Detrick to fully support end users and administrators. See PWS Section 5 (Travel ODCs)

Task 5: Option for increased quantities of software licenses, training and travel required over the life of the contract

IAW FAR Clause 52.217-6, the contractor shall provide preset pricing for additional new SW Licenses & Maintenance and for training, as required, over the life of the contract. The estimated number of each new license or support that may be required each year are unknown and will modified into this contract as required. There are no optional CLINS for this at time of award, but there is a great potential for increase quantities during the life of this contract.

3.0 DELIVERABLES

3.1 Delivery Address

All deliverables shall be submitted to the COR designated in the COR appointment letter and as directed by the COR upon award of the contract.

3.2 Method of Delivery

Electronic copies shall be delivered using Microsoft Office suite of tools (for example, MS WORD, MS EXCEL, MS POWERPOINT, MS PROJECT, or MS ACCESS format), unless otherwise specified by the COR. Electronic submission shall be made via email, unless otherwise agreed to by the COR.

3.3 Shipping

The Contractor shall use the U.S. Postal Service standard delivery for delivery of materials, equipment, or required hardcopy documents. The COR must approve all exceptions to this requirement.

3.4 Government Acceptance Period

The COR will have ten (10) workdays to review draft deliverables and make comments. The Contractor shall have five (5) workdays to make corrections. Upon receipt of the final deliverables, the COR will have two (2) workdays for final review prior to acceptance or providing documented reasons for non-acceptance. Should the Government fail to complete the review within the review period the deliverable will become acceptable by default, unless prior to the expiration of the ten (10) work days the Government notifies the Contractor in writing to the contrary. The final submission should be deemed approved if the Government has not rejected it in 30 days.

The COR will have the right to reject or require correction of any deficiencies found in the deliverables that are contrary to the information contained in the Contractor’s accepted proposal. In the event of a rejected deliverable, the Contractor will be notified in writing by the COR of the specific reasons for rejection. The Contractor shall have five (5) workdays to correct the rejected deliverable and return it per delivery instructions.

3.5 Delivery Schedule Abbreviations

The following abbreviations are used in the delivery/deliverable schedule:

3.6 Deliverable/Delivery Schedule

A summary of deliverables follows. Copies are to be provided to the Government officials electronically.

(This technical exhibit lists any reports or documentation that is required as a deliverable to include the frequency, # of copies, medium/format and who/where it is to be submitted. A deliverable is anything that can be physically delivered but may include non-physical things such as meeting minutes. Note: All PWS deliverables should be included in this exhibit.)

COR

4.0 CONTRACT ADMINISTRATION DATA

4.0.1 Recognized Holidays: Contractor is not required to perform services on the below Federal holidays.

4.0.2 Hours of Operation:

The contractor is responsible for coverage conducting business, between the hours of 08:00 am through 05:00 pm EST, Monday thru Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. For other than firm fixed price contracts, the contractor will not be reimbursed when the government facility is closed for the above reasons. The Contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential.

Some core labor coverage may contain some variant agreed upon at the kick-off meeting. Some mission requirements may require work before or after established core hours. Weekend and Federal holiday on-call coverage may be required. Official travel may require travel during hours and days outside of the norm e.g. long-distance CONUS or OCONUS travel in order to accommodate customer assist visit schedules agreed upon by DVBIC.

4.0.3 Security Requirements:

Contractor personnel performing work shall follow the MRDC personnel security policy for gaining clearances and common access cards.

4.045 Physical Security:

The contractor shall be responsible for safeguarding all government equipment, information and property if/when provided for contractor use. At the close of each work period, government facilities, equipment, and materials shall be secured.

4.0.5 Key Control:

The Contractor shall establish and implement methods of making sure all keys/key cards issued (if required) to the Contractor by the Government are not lost or misplaced and are not used by unauthorized persons. NOTE: All references to keys include key cards. No keys issued to the Contractor by the Government shall be duplicated. The Contractor shall develop procedures covering key control that shall be included in the Quality Control Plan. Such procedures shall include turn-in of any issued keys by personnel who no longer require access to locked areas. The Contractor shall immediately report any occurrences of lost or duplicate keys/key cards to the COR.

5.0 Place of Performance:

The Contractor shall perform the primary (SW) services at Fort Detrick, MD with reachback support from the Contractor’s facility. The Government will provide access to Government controlled facilities, equipment, and materials for daily business use of staff called for under this order if required. The Contractor will be provided keys or codes for access to the Government facility if required. These keys and codes shall be controlled, tracked, and protected. Upon termination of the period of performance, all keys and/or access badges provided by the Government for the Government facility shall be turned in to the COR.

5.1 Other Direct Costs (ODCs)

The Government intends to utlize “Plugged” Not-to-Exceed (NTE) amount for all ODCs listed below.

5.1.2 Travel ODCs

The Government intends to utilize a “Plugged” Not-to-Exceed (NTE) amount for all ODCs (to include Travel – See ODC Matrix Below). This plugged value is inclusive of all items outlined in PWS Section 2.2 (Task 4 – Training and Consulting Support Services).

ODC Matrix: Base Period & All Option Periods

Arrangements for and costs of all travel, transportation, meals, lodging, and incidentals are the responsibility of the Contractor. Travel costs shall be incurred and billed in accordance with FAR Part 31. Costs for these expenses will be reviewed, certified and approved by the COR. All travel and transportation shall utilize commercial sources and carriers provided the method used for the appropriate geographical area results in reasonable charges to the government. The Government will not pay for business class or first-class travel. Lodging and meals shall be reimbursed in accordance with regulations defined in FAR PART 31.

5.1.3 Travel Outside of the U.S.

Not applicable to this task.

5.1.4 Training ODCs

The Government intends to utilize a “Plugged” Not-to-Exceed (NTE) amount for all Training ODCs – See ODC Matrix Below. This plugged value is inclusive of all items outlined in PWS Section 2.2 (Task 3 – Training Services).

ODC Matrix: Base Period & All Option Periods

The Government will request training based on frequency and need and will coordinate with the Contractor when training requirements are requried. Basic training requirements are outlined in PWS Section 2.2 (Task 3) and the contractor is required to provide basic training pricing (if not seperately priced elsewhere) and these prices will be utilized to request and fund training as required throughout the life of this contract.

6.0 OTHER TERMS, CONDITIONS, AND PROVISIONS

6.1 Non-Disclosure Agreement – Deliverable 1

The Contractor shall ensure that the Non-Disclosure Agreement (Attachment B to PWS) (Deliverable 1) is signed by all staff assigned to or performing on this Task order before performing any work, including all subcontractors and consultants. The Non-Disclosure Agreement shall be cosigned by a corporate official (Contractor Task Manager or higher). The Contractor shall also ensure that all staff understand and adhere to the terms of the non-disclosure statement, protecting the procurement sensitive information of the Government and the proprietary information of other Contractors. Assignment of staff who have not executed this statement or failure to adhere to this statement shall constitute default on the part of the Contractor. All Non-Disclosure Agreements shall be submitted NLT 30 days after award of this task order.

6.2 Service Contract Reporting

Service Contract Reporting (SCR) has replaced Contractor Manpower Reporting (CMR) Requirement. Service contractor reporting of information is required in the System for Award Management (SAM) for:

• Contract Awards, no IDVs

• Contract Awards include purchase orders, delivery/task orders, BPA calls, and definitive contracts

• Service Contracts, i.e. any PSC that starts with a letter excluding utility PSCs (S110, S111, S112, S114, and S119)

• All cost-reimbursement, time-and-materials, and labor-hour service contracts with an estimated total value > $150,000 and base date signed is between 10/1/13 and 9/30/18.

• Fixed Price Contracts: If the contract's base date signed AND base effective date is between 10/01/2013-09/30/2014, the total contract value must be >= $2.5M

• Fixed Price Contracts: If the contract's base date signed AND base effective date is between 10/01/2014-09/30/2015, the total contract value must be >= $1M

• Fixed Price Contracts: If the contract's base date signed AND base effective date is between 10/01/2015-09/30/2018, the total contract value must be >= $500,000

Steps for Submitting a Service Contract Report (SCR)

1. Go to www.sam.gov and log in.

2. Select Entity Registrations and then select Service Contract Reporting.

3. SAM displays your entities which have service contracts and meet the reporting criteria. Select View by entity to see the service contracts for each entity.

4. Next, select Add for the service contract against which you want to create a Service Contract Report. Each service contract which meets the FAR Subpart 4.1703 reporting thresholds is displayed.

5. You will be taken to the Complete Service Contract Report page. SAM displays the contract details and allows you to report. You are required to enter the following information:

• Total Amount Invoiced: Total dollar amount invoiced for services performed during the previous Government fiscal year under the contract (this amount should include the prime and any subcontract amount).

• Prime Contractor Hours Expended: Prime contractor direct labor hours expended on the services performed during the previous Government fiscal year. The amount you enter is automatically divided by 2,080 hours to calculate a Full Time Employee (FTE) equivalent, displayed under the Prime Contractor Hours Expended as Prime Contractor FTEs.

6. Report any required Tier 1 subcontractor information by selecting the Add Tier 1 Subcontract Information button.

7. When you are ready to submit the report, select Submit. This saves your report and returns you to the Select Service Contract page where you can create other SCRs or edit an existing SCR.

6.3 Contractor Employees

Attendance at Meetings

Post Award Conference/Periodic Progress Meetings: The Contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5. The contracting officer, Contracting Officers Representative (COR), and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the contracting officer will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

Contractor personnel may be required to attend meetings or otherwise communicate with Government and/or other contract representatives to meet the requirements of this order. Contractor personnel will make their Contractor status known during introductions.

Use of Military Rank by Contractor Personnel

Contractor personnel, while performing in a Contractor capacity, are prohibited from using their retired or reserve component military rank or title in all written or verbal communications associated with the contract under which they provide services.

6.4 Data Rights

The Government will retain rights to all data produced in the course of developing, deploying, training, using and supporting the eIT PMO.

The Government has unlimited rights to all documents/material produced under this contract. All documents and materials, to include the source codes of any software, produced under this contract shall be Government owned and are the property of the Government with all rights and privileges of ownership/copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the contractor without written permission from the Contracting Officer. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

6.5 Quality Assurance

The Government will review Monthly Progress Reports and will attend regular task performance review meetings with the Contractor to survey quality of products and services. The government shall evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan. This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

6.5.1 Quality Assurance Surveillance Plan (QASP)

The Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the Contractor’s performance. The oversight provided for in the order and in the QASP will help to ensure that service levels reach and maintain the required levels throughout the contract term. Further, the QASP provides the COR with a proactive way to avoid unacceptable or deficient performance, and provides verifiable input for the required Past Performance Information Assessments. The QASP will be finalized immediately following award and a copy provided to the Contractor after award. The QASP is a living document and may be updated by the Government as necessary.

6.5.2 Performance Requirements Summary Matrix

By monitoring the Contractor, the COR will determine whether the performance levels set forth in the order have been attained. Performance standards are specified in the following Performance Requirements Summary Matrix in the Standard and Acceptable Quality Level columns.

eCTD Software Standard Level for Software Maintenance (Times are Eastern Time/ET)

Standard Level for Support Services

Task 2.

Work collaboratively with eIT PMO staff to successfully upgrade and validate the software. This will include the development /modification of installation instructions to allow the products to function within the parameters specified for Department of Defense Installation.

Project management/technical consulting/regulatory consulting services are provided as requested by eIT PMO Software implemented on DoD servers in accordance with all current DOD requirements.

Engagement. Technical or regulatory requests are provided through the project manager are addressed

All installation performed successfully and all validation issues resolved Direct observation and 100% inspection

Task 3 Provide training and documentation to product administrators, advanced users, and general users to support all products and modules delivered under this contract.

PWS Attachment A

Software System Requirements

Overview The eCTD Publisher System is intended for use by USAMRDC eIT PMO customers/user base for preparation, and life cycle maintenance of electronic regulatory submissions originating from the Army Office of the Surgeon General (OTSG) sponsored investigational product development. The critical function of the system is the ability to generate electronic regulatory submissions. In addition, the system shall have the ability to automate workflow steps required to manage preparation of electronic submissions for submission to regulatory agencies (e.g. US FDA).

The eCTD publishing system shall be used for:

· Preparation and lifecycle maintenance of electronic regulatory submissions

· Greater efficiency within Regulatory Submissions

· A higher level of compliance with applicable regulations

The eCTD publishing system shall have the ability to:

· Scale the system to handle a larger number of submissions with increased complexity

· Provide seamless access to third parties (e.g. external regulatory reviewers, consultants, CRO’s, etc.)

· Integrate the eCTD publishing system with other key USAMRDC systems (e.g. Open Text – Content Server)

User Requirements:

The requirements listed in the tables below shall be accommodated by the vendor offering a complete eCTD Publishing System.

Electronic Common Technical Document (eCTD) Software

4.2 User & Software Requirement/Specification Categories

4.2.1 Submission Assembly Category

4.2.2 Opentext Content Server 10.5 (EDMS) Integration Category

4.2.3 Submission Publishing (eCTD) Category

4.2.4 eCTD Validation Requirements Category

4.2.5 Submission Publishing (Paper) Category

4.2.6 Submission Viewing, Distribution and Archival Category