Analytical instruments and computerised systems operating in regulated laboratories must be fit for intended use. This is achieved by using a combination of analytical instrument
qualification (AIQ) and computerised system validation (CSV). In the current regulatory environment instruments and systems must ensure data integrity and therefore technical controls must be enabled to ensure this as well as being included within the scope of a CSV project. Regulations, either current interpretations of existing ones or following the issuance of updated ones, allow for risk-based approaches but many laboratories either do not consider this or are held back by ultra conservative quality assurance departments. This course is intended to take a practical and risk-based approach to integrated AIQ and CSV. Instead of automating the status quo any laboratory process should be mapped and redesigned for electronic working by removing spreadsheets and paper printouts. To achieve this requires the implementation of applications that are technically compliant. To reduce the amount of work in a CSV project we will consider:
• Effective interpretation of applicable regulations and guidance
• How to leverage supplier development and testing into the project
• Understand the key principles ofthe FDAs newComputer SystemsAssurance initiative to CSV.
• Effective use of risk assessment to focus testing
• Impact of IaaS (Infrastructure as a Service) and SaaS (Software as a Service) on CSV projects for larger laboratory informatics applications such as ELNs, CDS and LIMS.
• Effective risk-based change control from operating system patches to application upgrades