URS technical review is for technical subject matter experts. For example QA should review a URS against the applicable regulations. Need to be clear on the differences between system owner and process owner. If none of these, no need to validate, good engineering practice is sufficient. Validate only if there could be an impact on patient safety, product quality, data integrity. Most computerized systems now based on configurable packages, many of them networked. Terminology is still available, but optional. Terminology confuses people outside of the validation and QA departments. Moving away from traditional qualification terminology (e.g. Increasing complexity and/or novelty = higher risk = more effort and deliverables.
Novelty: Excel = used by millions worldwide, lab instrument PC software = used by thousands worldwide, in-house developed application - used only by the company that developed it.Complexity: SAP = high complexity, Excel spreadsheet calculating lab results = low complexity.Risk: manufacturing process control = high risk, database containing training records = low risk.All lifecycle activities and associated documentation are to be scaled according to risk, complexity, novelty. įew of the Important Points: GAMP 5 is not prescriptive.by fully integrating engineering and computer system activities so that they are only performed once) Leverage supplier activities to the maximum possible extent, while still ensuring fitness for intended use. Scale all life cycle activities and associated documentation according to risk, complexity and novelty. Recognise that most computerised systems are now based on configurable packages, many of them networked. Acknowledge that traditional linear or waterfall development models are not the most appropriate in all cases. Ĭoupled to this there is the need to: Avoid duplication of activities (e.g.INTRODUCTION… GAMP 5 is applicable to a wide range of information systems, lab equipment, integrated manufacturing systems, and IT infrastructures After over 4 years of re-work GAMP 5 was released in Feb 2008,and is a major rewrite of GAMP 4 with significant changes having as primary goals: Bringing procedures in line with the dynamic Life science industry reducing the cost of compliance
INTRODUCTION GAMP 5 leverages risk management from GAMP 4 and addresses the entire lifecycle of automated systems The biggest change being to provide more clearly defined scalability for effort / deliverables versus the size / complexity of projects, and to align with the various regulatory bodies’ emphasis on risk / science-based GxPs. GAMP 5 aligns with major industry developments including PQLI1, ICH Q8, Q9, Q10, and ASTM E2500 and points to the future of computer systems compliance