21.CFR.11 DOCUMENT MANAGEMENT SYSTEM

21.CFR.11

DOCUMENT MANAGEMENT

SYSTEM

User Requirements Specifications

PRESENTED BY: CARL WEISS

Court Square Group Massachusetts U.S.

Table of Contents

21.CFR.11

Document Management System

1. Introduction 3

2. Scope 3-5

3. Approval Signatures 5

4. About Court Square Group 6

5. About RegDocs365 7

6. For More Information 7

CourtSquareGroup.com 413.786.0054 Page 2 7

1. INTRODUCTION

A Document Management System (“the System”) is intended to function as a secure

Document Application for storing, indexing and collaborating on eTMF, EDM, and

corporate documents in a secure, limited-access, configurable environment with

user-defined folder structures, views, security roles, and access.

The System has the ability to accept migrated data from external systems and

sources. The System is will be hosted off-premises and will include a Development,

Test, and Production environment.

The System will be composed of hardware and software as described in a System

Design Specification.

This User Requirements Specification (URS) is an integral part of the procurement

agreement with the Supplier. The Supplier will abide by the information and

conditions set forth by this document as well as the standard purchasing terms

and conditions.

2. SCOPE

This document defines the user and system functionality and requirements for the

System.

The Requirements Matrix below denotes each requirement with the capability of the

System to provide the functionality (Technical) or the requirement for an SOP or

procedural control (Procedural).

User and system requirements must be tested and verified, and evidence must be

collected to support that the requirements are met. Traceability will be established

between the test scripts executed to satisfy each requirement.

21.CFR.11 DOCUMENT MANAGEMENT

Document Title: 21.CFR.11 Compliant User Requirement Specifications

Document No.: (Insert Document # Here) Version No.: 1.0


Note: The term “Item” is used herein to refer to Documents, Files of other Types, and List Items. Requirements that refer to Items are required for all item types listed.

USER AND SYSTEM REQUIREMENTS

Requirement

No. Requirements

1.1 General Requirements

1.1.1 System has ability and structure to store all required records essential for

storage of Clinical Trial study and compound supported artifacts.

1.2 Regulatory Requirements

1.2.1 Limiting system access to authorized individuals.

{21 CFR 11.10(d)}

1.2.2

Use of secure, computer-generated, time-stamped audit trails to inde-

pendently record the date and time of operator entries and actions that

create, modify, or delete electronic records.

{21 CFR 11.10(e)}

1.3 General System Functionality

1.3.1 Users with relevant software applications on desktop are capable of opening

files.

1.3.2 Ability to create multiple document libraries, lists, and folders.

1.4 System Access and Security

1.4.1 Ability to access the System remotely.

1.4.2 Multiple user groups and permissions can be defined.

1.4.3 Users have ability to change passwords or request reset of password.

1.4.4 Ability to define System, site, library, list, folder, and item level permissions




USER AND SYSTEM REQUIREMENTS

Requirement

No. Requirements

1.5 Item Functionality, Properties, and Management

1.5.1 Ability to create new items in the system by uploading from external sources.

1.5.2 Ability to export copies of files in native format.

1.5.3 System allows for naming of items and assignment of metadata upon creation,

upload, or import of the item.

1.5.4 Ability to configure and utilize major and minor versioning for items.

1.5.5 Ability to ensure all item versions are retained by system.

1.5.6 Ability for users to view previous item versions.

1.5.7 Ability to require checking-out to edit files and metadata.

1.6 Metadata Functionality, Properties, and Management

1.6.1 Ability to configure metadata field entry mode (e.g. free text, look up, radio

button, etc.).

1.6.2 Ability to configure which metadata fields are required to contain values prior

to new item being created, uploaded, and imported.

1.7 Change Management

1.7.1 Ability to track changes made by authorized users to System configuration and

design.

1.7.2 Ability to require that checked-out items can only be checked-out to one user at

a time.

1.7.3 Ability for System to track item creation and modification dates.

1.8 Searching and Views

1.8.1 Ability to search the System for any content (excluding unsearchable PDF and

audio files) or metadata.

1.8.2 Ability to create and save views, based on metadata, privately and publicly for

reuse.




3. APPROVAL SIGNATURE

The signatures below attest to the signers’ agreement that this document

adequately describes the user and system requirements for the RegDocs365

environment.

Approver:

[Insert Name], [Insert Title], [Insert Organization] Date

Approver:

[Insert Name], [Insert Title], [Insert Organization] Date

Approval

Date:




Compliant Qualified and Validated Hosting and Regulatory Submission Tools

for Life Sciences

Court Square Group is the leading provider of an Audit Ready Compliant Cloud™

(ARCC) platform for Life Science companies. The ARCC cloud platform and out-of-the

-box tools provide a validated and cost-effective way to manage all digital content

(EDMS/documents, voice, data, and video) in a regulated and compliant environ-

ment. At every stage of the development and manufacturing lifecycle, Court Square’s

cloud, collaboration and regulatory submission solutions reduce costs, complexity

and risks associated with sharing, storing, and submitting information for regulatory

requirements. With over 1,000+ submissions and twenty-five years’ experience and a

95% client retention rate, Court Square Group has a proven track record as the most

cost-efficient solutions in the life science market.

4. About Court Square Group

5. ABOUT REGDOCS365

6. FOR MORE INFORMATION

Regulatory Submissions and Collaboration Solutions for Life Sciences

Companies and CROs

RegDocs365 is an out-of-the-box, scalable, real-time collaborative solution for CRO’s,

Life Science Consultants, Regulatory Groups and industry stakeholders built in an

Audit Ready Compliant Cloud™ (ARCC) environment. RegDocs365’ 21 CFR Part 11

compliant tools include eSignature, eCTD, EDM & eTMF Reference Models, GxP audit

ready and submission-ready PDF rendering. Compliance Built-in; Ready to Use;

Configurable Workflows; Real-Time Collaboration; Content Management; and

Submission Management.

Court Square Group has helped hundreds of life science organizations to leverage

technology to improve clinical trial management and regulatory submissions.

If you need assistance in defining your user requirements, or if you are looking for a

life sciences document management solution, contact us at (413) 746-0054 or

[email protected].

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