Risk-Based Validation of Laboratory Computerised Systems MasterClass

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 req... Read more

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.