Pharmaceutical & Biotechnology Corrective Action (CAPA) Software Systems

MasterControl Pharmaceutical and Biotechnology Corrective Action (CAPA) Software Systems Help Biotechnology and Pharmaceutical Companies Comply with GMP 21 CFR Part 211 and 21 CFR Part 11

A pharmaceutical and biotechnology corrective action and preventive action system especially designed for the overall effort to investigate and correct quality issues to prevent recurrence is an important principle under the Current Good Manufacturing Practices (CGMP) found in 21 CFR Parts 210-211, which cover the pharmaceutical and biotechnology industries.

Although the regulation does not use the term "CAPA," Section 211.192 essentially requires CAPA by mandating a thorough investigation of any discrepancy or failure of a batch (or any of its components) to meet specifications. It also requires a written record of the investigation, including conclusions and follow-up which is available in specialized systems like the pharmaceutical and biotechnology CAPA software offered by MasterControl.

Simplify CAPA in 7 Steps
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