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:
Literature

CFR Compliance Pace

21 CFR part 11 Brochure

Héma-Québec Profile
• 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
Pharmaceutical Customers
Some of our FDA-regulated industry customers include:
•AstraZeneca
• Abbott Labs
• Amgen
• Aventis
• Boots
• Colgate-Palmolive
• Eli Lilly
• Ethicon
 • GlaxoSmithKline
• Johnson & Johnson
• Merck
• Novartis
• Pharmacia
• Pfizer
• Schering-Plough
• Wyeth
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info@paceintegrated.com