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 requires the implementation of applications that are technically compliant.

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