Risk-Based Validation of Laboratory Computerised Systems MasterClass on May 19-20, 2021 in Budapest, Hungary

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.