Validation and Compliance

Validation and compliance is a critical aspect within GxP relevant industries and qualification of computer systems (CSV / CSA), laboratory analytical instruments, equipment, process and Medical Devices with the corresponding compliance approaches, systems and ISO processes play a valuable role in ensuring quality compliance. Whether CLOUD or On-premise, informatics platforms require validation to meet various regulatory requirements and standards. Zifo validation team has experience ranging from Validation strategy definition and project planning to Validation execution (IQ/OQ/PQ) and validation process consultation support (e.g. SOPs / Policies).

Computer System Validation (CSV)

CSV validation strategy, IQ, OQ, PQ development and qualification, risk-based validation, execution and reporting across 21 CFR part 11, GLP, GMP, GAMP for all lab software platforms e.g. CDS, EDC, ELN, LIMS, in the cloud and on-prem

Lab Instrument Validation

Instrument validation strategy, IQ, OQ, PQ qualification, risk-based approaches, execution and reporting across 21 CFR part 11, GLP, GMP, GAMP for all analytical instrument hardware platforms

Quality & Compliance

New quality system design/delivery/maintenance, auditing against regional regulatory guidelines (21CFRpart11, GLP, GMP, GCP, GAMP5), quality system audit and recommendations, quality system best practice adoption

Software as Medical Device (SaMD)

SaMD validation strategy, IQ, OQ, PQ development and qualification, software validation execution and regulatory reporting across SaMD regulations