Transforming life sciences in the cloud

Continuous Validation

An important part of regulatory compliance is validation. The FDA and other regulators require that all equipment, systems and processes be validated for compliance. Validation is intended to assure regulators that the process or system in question will meet all established acceptance criteria; like all things regulatory, this validation must also be documented thoroughly.

All validation documents must be made available to the FDA or other regulators upon demand. And in an increasingly digital world, validation of all GxP computerized systems is especially important; these must be validated before being placed into service and re-validated as needed. For instance, a software upgrade may warrant a re-validation of a system.

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