As a 'Thank You' for our Newsletter Subscribers Labcompliance offers every month one document for free. This month's document is entitled:

Development of Requirement Specifications for Computer Systems

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.

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

Offer expired on August 15, 2007.

Example SOPs from Labcompliance help to develop and maintain your own SOPs. Currently more than 70 SOPs are available for:

Quality System and Management Procedures

Qualification and Validation, including computer validation, part11

General Laboratory Compliance

Qualification/Validation in Laboratories

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