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An Integrated Approach In Managing CPV And APQR
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Both Continued Process Verification (CPV) and Annual Product Quality Review (APQR) use shared data such as process and product campaign data, quality event data, and trending analyses, yet they often remain separate, leading to redundant tasks like duplicate data collection, overlapping analysis, and repetitive reporting. Integrating CPV and APQR workflows would streamline these processes and improve efficiency.
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There’s significant overlap between CPV and APQR, yet these programs are often managed separately resulting in redundant activities. In this webinar, we focus on how to integrate CPV and APQR programs, how to automate many CPV and APQR tasks, and how to enhance regulatory compliance.
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Regulatory authorities require biopharma manufacturers to ensure their processes remain in a state of control so the strength, quality, and purity of the final drug product are maintained. Here we describe ways to automate CPV and offer a one-click solution for statical trending of data, campaign reporting, and capability analysis.
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With a process monitoring tunnel, you can monitor 100s of CPPs in a single graphical interface that captures the overall health — both past and present — of your bioprocess and reliably predicts its future health.
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21 CFR Part 11 regulations describe how electronic records and signatures can be considered equivalent to paper-based records and handwritten signatures. But software offers additional benefits like: 1. data integrity; 2. audit trails; 3. easy search and retrieval of information; and, 4. electronic backups.
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