Smart Solutions for Pharmaceutical/Biotech Companies
||PACE provides innovative solutions to address the diverse and demanding applications of the pharmaceutical and biotechnology industry.
The FDA is stepping up regulatory enforcement. Is your facility audit-ready? If not, you face possible Notices of Inspectional Observations (483s), Warning Letters even substantial fines and plant shutdowns! Achieving compliance is no small task! Its scope extends beyond a company’s environmental and production control systems and operating procedures into virtually every area of the plant and across entire regulated industry supply chains.
Today, PACE has taken this leadership role a step further to help FDA-regulated businesses comply with 21 CFR Part 11. Introducing CFR Compliance Pack. This enhancement to our Continuum® software provides facility-wide accountability and traceability of both the environmental and security conditions that can impact the quality and safety of the end product. A temperature set point change, the addition of an improper ingredient, a change in relative humidity, a variation in ultraviolet light levels or, just as importantly, unauthorized access to a lab area or computer system CFR Compliance Pack answers the who?, what?, when?, where?, and why? for these events. PACE we have you covered.
Through an intuitive user interface, PACE provides integrated, single-seat control for:
CFR Compliance Pace
21 CFR part 11 Brochure
||• Easy Setup and Operation
• Comprehensive Personnel Information Management
• Tailored Security Levels
• Detailed Audit Trails
|• Secure Data Logging and Archiving
• Advanced Alarm Management
• Flexible Reporting Options
• IT Resource Protection
Some of our FDA-regulated industry customers include:
• Abbott Labs
• Eli Lilly
• Johnson & Johnson