Abstract

DIGITAL DOCUMENTATION IN MODERN PHARMACEUTICAL QUALITY ASSURANCE: A STRATEGIC REVIEW

Sanket N. Aher*, Ganesh B. Sonawane, Vijayraj N. Sonawane, Pooja A. Gunjal, Jayshri B. Bacchav

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Abstract

The shift to digital solutions in quality assurance (QA) in the pharmaceutical industry is marked by the replacement of paper based methods with more advanced technological systems. The use of electronic Batch Manufacturing Records (e-BMR) and electronic Batch Packaging Records (e-BPR) enhances compliance and operational efficiency by capturing data in real time and automating workflows. Remote quality assurance and monitoring is possible, which significantly reduces manual oversight. These systems also aid in minimizing human error, automating manual procedures, and expediting batch release in a unified, standardized manner across all sites. AI, IoT, and blockchain technologies are deeply integrated within the documentation systems, allowing for advanced predictive quality control and early detection of deviations, guarantees and tamper-proof audit trails that ensure system integrity. Tools, like Werum PAS-X Manufacturing Execution System (MES) and Honeywell Forge, have shown a quantifiable enhancement in batch monitoring, deviation tracking, and regulatory reporting accuracy. These systems and processes also guarantee utmost compliance with global regulations like FDA 21 CFR Part 11, EU Annex 11, and India’s Schedule M. The primary concern of shift to digital systems in the pharmaceutical industry would stem from expensive initial investments, the cost of integrating with legacy systems, and the exhaustive need for validation processes. Regardless, the advantages of digital documentation.

Keywords: Electronic Batch Records, Digital Documentation, Pharma 4.0, Data Integrity, Regulatory Compliance, Pharmaceutical Quality Assurance.