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Validation Services & Compliance Support

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 , informatics platforms require validation to meet various regulatory requirements and standards. 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).

zifo - software as a medical device companies

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

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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

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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

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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

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