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We are regularly approached to support Computer Systems Validation (CSV) exercises on projects for end-clients and suppliers to the lifesciences industries. The notes below are to provide you with an overview of the information we will require to complete a full and thorough review of the CSV scope; this information is normally provided after competing a Non-Disclosure Agreeement (NDA) which we can provide if you don’t have your own pro-forma. End-clients Performing a full review/gap analysis of the Computer Systems Validation lifecycle deliverables and supporting activities for the equipment/software system in scope requires: a copy of your validation policy/procedures. a…
What is it: March 1997 United States Food and Drug Administration (FDA) regulation, followed by an August 2003 guidance document on the scope and application of Electronic Records and Electronic Signatures. Who’s it for: All lifesciences companies (end-clients, suppliers, and service providers). What’s it about: Industry standard definitions of Electronic Records requirements (regulatory GxP data management, audit trails, security access controls, validation) to be considered equivalent of paper records, and Electronic Signatures to be considered legally binding equivalent of handwritten signatures. How can I use it: If you’re an end-client writing a User Requirement Specification for a new system or…
Computer Systems Validation (CSV) is a formal process to verify that: systems consistently operate as they were intended. user, business and regulatory system requirements are met. information/data is secure and properly managed by the system. procedures and processes are in place for the operation, management and maintenance of the system. To achieve this involves completing (and maintaining) a validation exercise, which utilises a risk-based lifecycle (GAMP5 is the industry standard), focussing on: Patient Safety. Product Quality. Data Integrity. It is important (and cost effective) to leverage as much as possible from your Suppliers (after they pass your Supplier Assessment process)…