System s (URS) System Document Control System Document ID URS000XXX Version 1 DOCUMENT APPROVALS Reason For Signature Name Position Signature Date Prepared by Vic Johnson Project Manager Checked for accuracy and completeness by QA representative, FCP Checked for accuracy and completeness by Approved by Quentin Jones QA representative, FCP Director, Quality Assurance, FCP VERSION HISTORY VERSION REASON AUTHOR NUMBER 1.0 Initial Version Vic Johnson VERSION DATE
TABLE OF CONTENTS DOCUMENT APPROVALS...1 VERSION HISTORY...1 1 INTRODUCTION...3 1.1 PURPOSE OF THIS DOCUMENT...3 1.2 SCOPE...3 2 OVERVIEW...3 2.1 BACKGROUND...3 3 FUNCTIONAL REQUIREMENTS...4 3.1 shared requirements for electronic data systems...4 3.1.1 General use of system...4 3.1.2 System access...4 3.1.3 Audit Trails / Event Logs...4 3.1.4 Electronic Records...5 3.1.5 Electronic Signatures...5 3.2 REQUIREMENTS FOR DOCUMENT CONTROL...5 3.2.1 Creating a controlled document...5 3.2.2 Reviewing a controlled document...6 3.2.3 Approving a controlled document...6 3.2.4 Archiving a controlled document...6 3.2.5 ENVIRONMENTAL REQUIREMENTS...6 3.2.6 INTERFACE REQUIREMENTS...7 3.3 Constraints...7 3.3.1 LOGISTICAL CONSTRAINTS...7 3.3.2 MAINTENANCE AND SUPPORT...8 3.4 Implementation s...8 3.4.1 Conversion of existing documents to new system...8 3.4.2 Training...8 3.4.3 Ongoing system use and management...8 Systems s FCP Doc Control Doc No: URS000XXX Page 2 of 8 6/15/2006
1 INTRODUCTION 1.1 PURPOSE OF THIS DOCUMENT The purpose of this document is to capture the major user and functional requirements of a document control system. All requirements are identified with a unique number in order to provide the ability to cross-reference requirements to testing in a traceability matrix, if required. The requirements have been organised in sections. The order of the sections and requirements within the sections do not indicate any priority within the system. 1.2 SCOPE The requirements will cover: General System use Regulatory s, such as Audit trails, Electronic Records and Electronic Signatures Document Control s Environmental s Interface s Implementation s 2 OVERVIEW 2.1 BACKGROUND First Class Pharmaceuticals is a pharmaceutical company involved in the manufacturing of Premier medicinal liquid products. FCP is in a state of rapid growth and is actively looking for a document management system as a means of creating and managing compliance documents, and some other types of documents used within the company. The purpose of the document control system will be to: Capture and control the documents that are produced during the development lifecycle of FCP s products Capture and control the documents used in production, such as raw material specifications, finished product specifications, batch records Act as a historical archive for the IP developed during specific phases of product development Monitor and record documents that are sent to partners for the purposes of technology transfer Act as a repository for all the company SOPs Systems s FCP Doc Control Doc No: URS000XXX Page 3 of 8 6/15/2006
3 FUNCTIONAL REQUIREMENTS 3.1 SHARED REQUIREMENTS FOR ELECTRONIC DATA SYSTEMS 3.1.1 General use of system 3.1.1.1 3.1.1.2 3.1.1.3 The system should be capable of operating on the current infrastructure without significant upgrades being required. The system must support the use and management of both hardcopy, hand signed original documents and electronic copies of documents. The system should support automatic escalation of overdue actions via FCP s email system. 3.1.2 System access 3.1.2.1 3.1.2.2 3.1.2.3 System access must be restricted to authorised users only and authority checks of users for access and use privileges must be in place. Authorised users must first be logged into the WAN/LAN before they are able to log into the application The network and server hardware must be physically secure 3.1.3 Audit Trails / Event Logs 3.1.3.1 The system must have audit trail functionality that identifies record changes, user ID, date and time, and reason for action/change. The record changes must not obscure preceding data or previously recorded information. 3.1.3.2 Users must not be allowed to disable the audit trail function. Systems s FCP Doc Control Doc No: URS000XXX Page 4 of 8 6/15/2006
3.1.4 Electronic Records 3.1.4.1 3.1.4.2 3.1.4.3 3.1.4.4 The system must provide the ability to generate accurate and complete records in human readable and electronic form. The system must be able to quickly retrieve (4 hours) electronic records and audit trail records throughout the retention period. The system must ensure that the electronic signature cannot be excised, copied or otherwise transferred to falsify an electronic record by ordinary means. Records must be secured from unauthorised access. 3.1.5 Electronic Signatures 3.1.5.1 3.1.5.2 Electronic signatures must be linked to electronic records. If a user makes a change to an electronic record, the user must be prompted to re-authenticate. 3.2 REQUIREMENTS FOR DOCUMENT CONTROL 3.2.1 Creating a controlled document 3.2.1.1 3.2.1.2 The system must allow any authorised user to create a document. There should be the ability to apply approved templates for each document type. Systems s FCP Doc Control Doc No: URS000XXX Page 5 of 8 6/15/2006
3.2.2 Reviewing a controlled document 3.2.2.1 3.2.2.2 The system should notify a reviewer that there is a draft document for review. The system should allow for more than one reviewer of a draft document. 3.2.3 Approving a controlled document 3.2.3.1 3.2.3.2 There should be only one document approver. This will usually be QA. The system should automatically notify the approver that there is a document for approval. 3.2.4 Archiving a controlled document 3.2.4.1 The system should allow for the archiving of controlled documents when; The document is no longer required (obsolete) The document has been superseded by a new version. 3.2.5 ENVIRONMENTAL REQUIREMENTS Users of the Document Control system will be office and laboratory based staff located at West Melbourne. There are no major unique environmental requirements for this system. 3.2.5.1 The server should be installed in a secured (logical and physical) computer room. Systems s FCP Doc Control Doc No: URS000XXX Page 6 of 8 6/15/2006
3.2.6 INTERFACE REQUIREMENTS 3.2.6.1 USER INTERFACE 3.2.6.1.1 Client PCs should access the system using a browser and standard Microsoft Office software. 3.2.6.2 SYSTEM INTERFACE There are not expected to be any interfaces to systems other than e-mail. 3.2.6.2.1 Notifications from the system should occur automatically, and therefore there will be a link to the FCP s email system. 3.2.6.3 EQUIPMENT INTERFACE There is no requirement to interface to any laboratory or manufacturing equipment / instrumentation. 3.2.6.3.1 The system must be able to support the use of network printers. 3.3 CONSTRAINTS 3.3.1 LOGISTICAL CONSTRAINTS 3.3.1.1 Users of the systems will be from within several departments at the West Melbourne site. Systems s FCP Doc Control Doc No: URS000XXX Page 7 of 8 6/15/2006
3.3.2 MAINTENANCE AND SUPPORT 3.3.2.1 Prefer local support from within Australia. Level 1 FCP personnel Level 2 Local support from within Australia Level 3 - Supplier of Document Control system (if different) 3.4 IMPLEMENTATION REQUIREMENTS 3.4.1 Conversion of existing documents to new system 3.4.1.1 3.4.1.2 There should be the provision to automatically migrate existing documents to the new document management system. The mechanism should be documented as either a plan or a procedure. All documents of a particular type should be migrated, even if they are becoming due for review. 3.4.2 Training 3.4.2.1 All personnel involved in configuration, validation, protocol establishment, scheduling, test result entry and reporting will be trained for the required functionality and have their training records documented. 3.4.3 Ongoing system use and management The following procedures should be created. 3.4.3.1 3.4.3.2 Use of the system Change control of the system, covering hardware and software Systems s FCP Doc Control Doc No: URS000XXX Page 8 of 8 6/15/2006