21 CFR Part 820 QSRs - Device
Biologics - Clinical - CMOs, CAOs...
Inefficient CAPA System for Corrective Action - Paper-based and spreadsheet type systems utilized for Corrective Action and Preventive Action are inexpensive initially, however, in the long term, these systems are inefficient, requiring tremendous man-hours in terms of routing CAPA tasks and other documentation, obtaining approval and signatures, and manual search and retrieval of documents during inspections and audits. Many audits have cited companies for lack of control and management over such paper and spreadsheet systems.
With manual and hybrid systems, these sources are not connected, making data collection slow and incomplete. Without connectivity, critical information may fall through the cracks, and the root cause investigation is likely to be unreliable.
Poor CAPA Reporting - When customer complaints, deviations, adverse events, and other incidents that can trigger a Corrective Action and Preventive Action are collected manually, there's no guarantee that all critical information will be captured because it is easy to misplace (and time-consuming to update) paper reports.
A hybrid system requires re-entering data from hard copy into an electronic system, a process prone to delay and mistakes.
Lack of CAPA Oversight - Poor implementation of CAPA systems a top reason for issuance of a Form 483) may stem from the lack of ability to track and monitor open CAPAs and proactively improve the CAPA process.
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