3. • History and overview on what Computer System Validation is, the benefits and
the consequences of not performing it or doing it right. (Case studies looked at)
• Overview on the different regulations and guidelines that give guidance on
computer systems validation; such as 21 CFR part 11,Guidance for Industry
part 11,Eudralex Annex 11 etc. (Scope of the regulations discussed)
• How Quality and Quality assurance fits into the Software development Life
cycle (The importance of the predicate rule in the software Development
Cycle).
• How the principles and fundamentals of project management are key in
software development and implementation.
The choice of model selected is key to the achievement of the intended
purpose.
Summary of CSV Boot Camp
4. • Overview on the general principles of software validation looking at the
different guidelines in place such as Annex 11,FDA guidance,GAMP etc.
• Risk management as a key input in every stage of the software development
life cycle as it will determine the extent of validation to be done and the data
integrity controls to be put in place.
Risk assessment should take into account the patient safety, the product
quality and data integrity
• Validation framework making reference to the GAMP 4 V diagram.
Examples cited and exercises done for each section in the V diagram.
Preparation of trace matrices, test summary and validation summary
reports.
• Discussion on procedures for reporting and resolving software issues, change
management for a validated system and procedures for system retirement.
Summary of CSV Boot Camp
5. • In any project, close cooperation is needed between all the relevant personnel
such as the process owner, system owner and the development team.
• Software development should be handled just as like any other project and all
principles of project management should be respected.
• URS & FRS are key to building a successfully software.
• Design reviews are key to elimination of errors before the software is launched.
• Change management and Incident reporting procedures in place should be
followed as stipulated.
• Assessment of Vendors based on complexity and criticality.
Key Takeaways
6. • Amend our URS & FRS for the ongoing LIMS project
• Audit the vendor for LIMS for compliance.
• Put in place as SOP for Computer System Validation, separate from that of
qualification
• Revise the Validation master plan for the Laboratory
• Perform and Independent code and Design for LIMS
• Training of all personnel in the basics of computer system validation
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