ENHANCING DATA INTEGRITY AND REGULATORY COMPLIANCE IN BIOMANUFACTURING USING PAS X MANUFACTURING EXECUTION SYSTEM

Abstract

Background: Data integrity and regulatory compliance a major issues in biomanufacturing and of specific concern with the rise of ever-more complicated biologics and personalized medicines. The conventional paper-based systems are unable to effectively adhere to the high requirements of Good Manufacturing Practice (GMP) and Good Automated Manufacturing Practice (GAMP5), and this causes transcription mistakes, bad traceability, and non-compliance with the regulations.

Objective: The paper is an assessment of Werum PAS-X Manufacturing Execution System (MES) and its capability of improving data integrity, facilitating regulatory compliance and enhancing efficiency of operations in biopharmaceutical manufacturing facilities.

Methods: Analytical research was used to evaluate the implementation of PAS-X MES through literature studies, regulatory and industry case reports. The main parameters analysed were the goal of compliances with the ALCOA+, the compliance with 21 CF Low-level roadmap and EU Annex 11, the efficiency of work indicators, including the minimisation of deviations and release of batches.

Results: PAS‑X MES succeeded in the elimination of data integrity issues as the tool established contemporaneous electronic capture of data, secure recorded audits, and role access restrictions. The system eased the FDA and EMA inspections, minimised deviations and enabled validation in compliance with GAMP 5. Right-first-time production, ease of interchange of information with the ERP and LIMS systems, as well as a 20-30% decrease in the time scales of releasing batches are operational advantages. Case studies in biologics, vaccines and cell & gene therapy manufacturing illustrate its adaptability and effectiveness across diverse manufacturing models.

Conclusion: PAS-X MES shows itself as a strong, compliance-able technology that is in par with Pharma 4.0. It must be adopted by the manufacturers who desire to promote data integrity, have a regulatory readiness, and improve operational excellence applications in contemporary biomanufacturing.