Factorytalk will join the TIPA event with a tabletop exhibit focused on Documentation Systems and Data Integrity in GMP-regulated pharmaceutical manufacturing.
A well-designed documentation system is a critical component of a pharmaceutical quality system. It ensures that all activities across Manufacturing, Quality Control, Engineering, Regulatory Affairs, and other departments are properly recorded, controlled, and verified to maintain product quality and regulatory compliance.
Recent GMP inspections worldwide have highlighted increasing concerns around documentation practices and data integrity, leading regulators to strengthen expectations through guidance such as PIC/S PI 041-1, WHO TRS 1033 Annex 4, and updates to EU GMP Chapter 4 Documentation.
One of the most critical records in pharmaceutical manufacturing is the Batch Record, which provides legal evidence that each batch has been manufactured and controlled according to approved procedures and GMP requirements.
Proper documentation design, control, and batch review are essential to ensure product quality and patient safety.
Visit Factorytalk at the Tabletop
At the event, Factorytalk will showcase innovative solutions that help pharmaceutical manufacturers strengthen documentation management and data integrity. Discover how digital solutions such as Electronic Batch Records (EBR) and MES, and Electronic Quality Management System (eQMS) can support organisations to:
- Improve data integrity and traceability
- Reduce manual documentation errors
- Accelerate batch review and release
- Strengthen GMP inspection readiness
