Achieve Proactive Quality with Deviations & CAPA Management

FDA’s Quality System Guide, recent Warning Letters, and EU-GMP Chapter 1 clearly emphasize the increasing relevance of proper deviation management and CAPAs. Check this week's newsletter to find how deviations need to be addressed, investigated, and based on investigation data, suitable corrective & preventive actions (CAPA) are applied to prevent their reoccurrence.?

Amplelogic's Deviation Management Software is designed to identify deviations and provide a streamlined investigation to resolve them.

Managing an unplanned change, or deviation is more complex than managing a planned change. Learn how an automated system can help companies to solve deviations efficiently.

"CAPA?is a key component in the GMP expectation for?deviation management, focusing on the investigation, understanding, and correction of discrepancies while attempting to prevent their recurrence."

Worried about CAPA? AmpleLogic's CAPA management software helps in addressing & improving the real-time problems of Pharmaceutical companies.

As per FDA Medical Device Warning Letters, inadequate CAPAs are the top runner with 1108 citations under 21 CFR 820.100(a) and 261 under ?21 CFR 820.100(b)?from FY 2017 to FY 2021.

CAPA Management Software Systems are an important part of a company's complete quality management system strategy. It is designed to effectively manage CAPA processes and integrate with other quality processes critical to regulatory compliance.

Conduct a systematic investigation of issues with the Corrective and preventive action plan outlined by the FDA.

Deviation & CAPA Management is an integrated part of Amplelogic Quality Management System QMS software that provides efficient support in handling deviation & CAPA processes. Trusted by Industry leaders.

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