Deviation Management

A deviation may occur during sampling and testing, or within raw materials and finished product acceptance and manufacturing. Deviations can be triggered by customer complaints or comments when a company's standards do not meet critical attributes as delivered per certificate.

GMP compliance

For compliance to GMP and the sake of continuous improvement, any deviation from established procedures needs to be recorded. FDA § 211.192 needs a thorough investigation of any deviation, including documentation of conclusions and follow-up. The quality management system should certify that deviations from established procedures are identified and documented.

Platina QMS for deviation management

Platina QMS provides efficient support for controlling deviation incidents, assists with the avoidance of deviation recurrences, applies corrective measures and takes a proactive approach to continuous quality improvement. The system offers deviation reports and remedial measure reports at any time, regardless of where in the organisation the deviation has occurred.

Deviation management deals with various kinds of deviations, such as standard (common) deviations and laboratory out-of-spec deviations. Our system provides predefined reports for initiating any possible deviation investigation. The entire deviation process is supported by the system, from initiation and investigation, to review, approval and closure in compliance with CFR 21 Part 11.

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