The manufacturing control of Camstar’s electronic batch record helps reduce scrap, batch paperwork errors and redundant checks; the flexibility to model and change complex processes based on the master batch record; and the real-time feedback needed to quickly identify and resolve batch record issues that inhibit process and product improvement. It easily manages a wide variety of processes, including personalized and autologous therapies, bio-diagnostics (reagents and instruments), assays, and others.
Camstar’s electronic batch record is fully 21 CFR Part 11 compliant, with electronic signatures and full data integrity and retention. As the electronic batch record is created, the system enforces the master batch record. The electronic batch record features comprehensive product and process tracking and control, including processes and equipment used, quality data, test results, non-conformances, materials consumed, process yield, operator signatures, and dates and times.
Life Sciences manufacturers are challenged daily to secure and sustain a profitable, growing business despite rigorous regulations and oversight, global competition and demand for customized products. Top Medical Device and Biotech companies have chosen the Camstar Manufacturing Execution System and its electronic batch records to reduce operating and compliance costs, improve quality and consistency, and shorten time-to-volume product cycles.