Biotech Suite

Camstar’s Biotech Suite is a best-in-class, Enterprise Manufacturing and Quality System created specifically for Biotechnology manufacturers. Supporting Titles 21 CFR Part 11 and 210-211 compliance, Biotech Suite provides the manufacturing control needed to help reduce scrap, eliminate costly paperwork errors and extended batch review times; the flexibility to model and change complex processes; and the real-time feedback needed to quickly identify and resolve issues that inhibit process and product improvement.

Camstar’s Biotech Suite’s unsurpassed flexibility makes it possible to model and manage a wide variety of processes, including those required for personalized and autologous therapies, bio-diagnostics (reagents and instruments), assays, and others.

More Manufacturing Control

Camstar’s Biotech Suite facilitates global manufacturing excellence, resulting in more consistent processes, continuous process improvement, efficient production scaling, reduced regulatory risks, and lower cost of quality and compliance.

Here’s how:

• Self-auditing manufacturing process executes production and automatically creates batch records, eliminating lengthy QA reviews
• Comprehensive product and process tracking, with real-time quality data collection, in a complex, iterative environment to simplify regulatory compliance
• Electronically managed specifications and procedures remove human error, resulting in more consistent products and less rework
• Automatic detection and control of non-conforming process results combined with structured data and failure analysis to improve product quality
• Failure analysis to improve product quality Web-accessible, structured data that production, quality, engineering and management use to solve issues quickly before they become product problems

Best of All Worlds

Camstar’s BioTech Suite is the only enterprise manufacturing application that offers:

• The most Biotechnology-specific out-of-the-box functionality AND
• highest level of configurability AND
• The most rapid deployment methodology

Biotech Suite is powered by Camstar’s leading InSite Enterprise Manufacturing and Quality System. InSite leverages leading edge technologies: It is completely Web Services enabled, provides a flexible data model and a configurable user interface that dramatically decreases the time and effort necessary to deploy and validate the solution.