Pharmaceutical companies are often on the cutting edge in terms of research, but when it comes to manufacturing they are, in many ways “tied up with paper”. Regulatory reporting burdens have transformed historically driven complex procedures and paperwork into electronic batch recording software in order to ensure compliance.
A significant problem with historic paper-based systems is that managing the paperwork takes a great deal of time and effort, and has substantial financial implications on pharmaceutical manufacturing operations. What is needed is a way to eliminate the paperwork and optimize the paperwork process: converting to electronic batch recording software. They will electronically capture and improve workflow activity, replace paper logbooks, keep track of everything that has affected a batch, manage the approval process, and more. Improving workflow management and information flow can dramatically improve quality, throughout and reduce manufacturing costs while satisfying regulatory requirements.
Today’s integrated electronic batch recording software can be applied from one end of the plant floor to the other, including the facility design and day-to-day maintenance. A dynamic electronic batch recording software includes components for the following:
• A security and audit component that addresses 21 CFR Part 11 concerns for electronic records and signatures, and provides audit trail services of all production and operations activities for all modules in the system.
• A content repository that provides controlled access to manufacturing documentation, and gives the company full control of all documents and version information.
• A training and development function that manages training courses and comprehensive training records, including the tracking of GMP training courses, scheduling of personnel, and real-time status confirmation of operator qualifications.
• An equipment tracking function that tracks definable equipment events like usage, cleaning, and maintenance in any manufacturing environment. It should provide paperless calibration records and equipment logbooks with real-time updating.
• A materials management module that provides both work in progress and centralized material management capabilities with container level tracking, material genealogy, and quality controls.
• Configurable electronic workflow that manages and sequences batch records, collects and consolidates all batch data and generates facility performance metrics, graphs and charts.
• An electronic batch recording software provides routing, review and approval of paperless manufacturing records for current good manufacturing practices (cGMP) facilities with complete product and activity genealogy.
• Easy integration to all existing plant floor systems and connectivity to high level applications such as Enterprise Resource Planning.
The opportunities are real and significant. Taking advantage of changes in regulations and leveraging new technology such as electronic batch recording software are making pharmaceutical manufacturing more competitive.