CAPA Management Software
Every pharmaceutical company undergoes a quality system inspection method (QSIT), which involves an examination of the company’s CAPA system. Its requirements for FDA-regulated pharmaceutical firms are stated in 21 CFR part 11, which specifies that “each manufacturer shall establish and maintain procedures for implementing corrective and preventive action”.
Corrective Action, according to the CGMP standards, is the process of finding and removing the underlying cause of a problem to avoid the problem from happening again in the future. Preventive action, on the other hand, refers to the steps taken by a company to avoid possible complications.
AmpleLogic CAPA Tracking Software
As a result of AmpleLogic’s CAPA Automation Software, the pharmaceutical and biotech industries are now able to solve real-time problems promptly. It fulfills the requirements of the Regulatory and Process Standard Requirements. By integrating additional modules such as OOS, OOT, Change Control, Deviation, Audit, Market Complaints, and so on, the software enables businesses to handle all CAPA activities in a timely and effective manner.
Business users may also utilize the system to complete the CAPA life cycle, from start to finish.
From deviations to OOS investigations, the AmpleLogic CAPA Management Software allows you to develop corrective or preventive measures