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Electronic Batch Record

The Camstar Enterprise Platform includes MedicalDeviceSuite™ and BiotechSuite™; it provides an electronic batch record that is a complete manufacturing audit trail of every batch produced. It replaces paper batch record forms with a self-auditing batch record process that eliminates costly paperwork errors and the requirement to review batch records manually. Electronic batch record data is accessible online, batch record throughput times are much shorter, and risks of non-compliance are reduced.
 

Manufacturing Control with Electronic Batch Record

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 Enterprise Platform and its electronic batch records to reduce operating and compliance costs, improve quality and consistency, and shorten time-to-volume product cycles.
 

"Camstar is a key enabler to help us get beyond quality and compliance and achieve quality excellence. It offers key process improvements like visibility into the manufacturing floor, real-time feedback and hard stops when needed to prevent defects from moving down the line."

- Mark Lincoln
VP of Quality and Operations, Terumo CVS
 

 "We standardized on Camstar's Enterprise Platform for our batch and discrete manufacturing processes in order to provide full traceability from finished product back to raw material, and to improve root cause analysis across multiple batches and devices. The single, integrated system gives us flexibility and configurability to meet the business needs of our hybrid operations. As a result, we have a much better understanding of our processes, fewer product issues, and higher yields for more reliable quality output."

- Manager, Manufacturing Systems, Leading Medical Device Manufacturer