Calibration Manager FDA Compliance

For over 10 years, Blue Mountain has been the leader in the life sciences manufacturing industry for calibration management software. Blue Mountain has combined FDA requirements, industry experience, and good manufacturing practices (GMPs) and good laboratory practices (GLPs) to develop a technologically advanced software application.

Calibration Manager is designed to be used in a variety of FDA-regulated industries, including pharmaceutical, biotech, medical device, and blood and tissue. In addition, departments such as R&D, QC, production, and engineering, can customize Calibration Manager to meet their specific needs.

GxP
Calibration Manager's comprehensive feature set, developed by working with the FDA, regulated companies, and trade organizations, makes it easy for companies to use while maintaining GxP compliance.

• Prevent missed calibrations with Auto Reminder
• Access records with Select and Sort functionality
• Print labels, certificates, and report forms with pre-defined compliance information
• Label each piece of equipment with a unique identifier
• Trace standards used to calibrate an instrument

21 CFR Part 11 ES/ER
Blue Mountain is the pioneer in electronic signatures/ electronic records for Part 11 compliance, as the first company to integrate this functionality into a calibration management software package. Blue Mountain has sold over 1,000 copies of Calibration Manager with Part 11 functionality - more than anyone in the industry.

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