Development of Requirement Specifications for Computer Systems

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1 Standard Operating Procedure Development of Requirement Specifications for Computer Systems This is an example of a Standard Operating Procedure. It is a proposal and starting point only. The type and extent of documentation depends on the process environment. The proposed documentation should be adapted accordingly and should be based on individual risk assessments. There is no guarantee that this document will pass a regulatory inspection. Publication from Global on-line resource for validation and compliance Copyright by Labcompliance. This document may only be saved and viewed or printed for personal use. Users may not transmit or duplicate this document in whole or in part, in any medium. Additional copies and licenses for department, site or corporate use can be ordered from While every effort has been made to ensure the accuracy of information contained in this document, Labcompliance accepts no responsibility for errors or omissions. No liability can be accepted in any way. Labcompliance offers books, master plans, complete Quality Packages with validation procedures, scripts and examples, SOPs, publications, training and presentation material, user club membership with more than 300 downloads and audio/web seminars. For more information and ordering, visit

2 STANDARD OPERATING PROCEDURE Page 2 of 7 Company Name: Controls: Superseded Document Reason for Revision N/A, new N/A Effective Date August 1, 2006 Signatures: Author Approver Reviewer I indicate that I have authored or updated this SOP according to applicable business requirements and our company procedure: Preparing and Updating Standard Operating Procedures. Name: Signature: Date: I indicate that I have reviewed this SOP, and find it meets all applicable business requirements and that it reflects the procedure described. I approve it for use. Name: Signature: Date: I indicate that I have reviewed this SOP and find that it meets all applicable quality requirements and company standards. I approve it for use. Name: Signature: Date:

3 STANDARD OPERATING PROCEDURE Page 3 of 7 1. PURPOSE The first and most important step of validation and qualification is writing the specifications. Without clear specifications computer systems cannot be fully tested. Well-written System Requirement Specifications (SRS) or User Requirement Specifications (URS) facilitate all consecutive validation/qualification steps and help to meet business objectives. Alternative approaches to this SOP can be applied as long as they are scientifically sound, comply with GxP requirements and are approved and documented. 2. SCOPE The SOP applies to the development of Requirement Specifications (URS or SRS) for Computer Systems used in GxP regulated environments. The SOP is limited to commercial systems. It is not applicable for equipment developed in-house. 3. GLOSSARY/DEFINITIONS Item Specifications URS FS SRS Explanation In the context of this SOP can be URS or SRS. User Requirement Specification Functional Specifications System Requirement Specifications. Typically combine URS and FS Note: For other definitions, see 4. REFERENCE DOCUMENTS 4.1. Validation Master Plan. Available from LabCompliance: SOP S-27!: Validation of Commercial Off-the-Shelf (COTS) Computer Systems. Available through

4 STANDARD OPERATING PROCEDURE Page 4 of 7 5. RESPONSIBILITIES 5.1. Anticipated Users Give input to the Specifications Review Specifications draft and final documents System Owner Takes the lead in getting user inputs into the Specifications Collects information from potential suppliers, e.g., specification sheets, data sheets etc Writes draft specifications Distributes draft specifications, collects inputs and updates the Specifications Operations Manager Drafts initial proposal for the project Reviews drafts and approves final Specifications Quality Assurance Department Advises on regulations and guidelines related to Specifications, if necessary Checks if process and documentation are in compliance with internal policies and regulations/guidelines Validation Group Checks compliance of specifications with internal validation guidelines Reviews and approves Specifications. 6. PROCEDURE 6.1. Proposal The Operations manager describes the need for a new computer system. This includes information on current solution, existing limitations and how the new system can solve the problem. It also includes a list with key features.

5 STANDARD OPERATING PROCEDURE Page 5 of The proposal is approved by higher-level management and submitted to the validation group The validation group reviews the proposal and asks for clarification, if necessary Draft A person with supervisor function from the operation is identified as the system owner The system owner describes the computer system in more detail. This includes the intended environment, the intended use and the type of anticipated users The system owner collects information on required functions from a selection of other anticipated users. Use template in Attachment The system owner drafts preliminary Specifications Required functions are numbered and entered in a table using the template in Attachment 7.2. This is the starting point for the traceability matrix. Vendor specification and data sheets can be helpful as inputs for the draft The preliminary Specifications are approved by the operations manager and passed onto the validation group The validation group reviews and approves or rejects the draft Final Document The system owner distributes the document to other users and asks for inputs The system owner arranges for a meeting with anticipated users to discuss and agree on final requirements The system owner evaluates the user inputs and updates the document Approvals The Specifications are reviewed and approved by the validation group The Specifications are reviewed and approved by the lab manager The Specifications are evaluated for compliance with regulations and internal policies by the QA department.

6 STANDARD OPERATING PROCEDURE Page 6 of 7 7. ATTACHMENTS 7.1. Attachment - Collecting Information for Specifications Employee: Supervisor: Department: Date: System ID: System Location: Category Requirement Must/Want

7 STANDARD OPERATING PROCEDURE Page 7 of Attachment Specifications Template Validation Group Leader/Author: Department: Date: System ID: System Location: Specifications Number/Identifier Requirement (This column should be used later on as link to test case)

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