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Camstar's Biotech Suites 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-complianceare reduced.
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.
Biotechnology manufacturers are challenged daily to secure and sustain a profitable, growing business
despite rigorous regulations and oversight, global competition and demand for customized
products. Companies like Favrille have chosen Camstar's Biotech Suite and its electronic
batch records to reduce operating and compliance costs, improve quality and consistency,
and shorten time-to-volume product cycles.
"Camstar's MES solution will replace our paper batch record with an
Electronic Batch Record that can streamline the collection
and management of manufacturing data. Camstar's advanced technology platform is
ideal for handling processes and calculations that are necessary in producing a
therapy based on each patient’s unique genetic information."
- Tamara A. Seymour
Chief Financial Officer, Favrille
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