The Power of Experience
We specialize in cGMP, GLP and GCP regulations.
PharmaSys has extensive experience and expertise with Good Manufacturing Practices, Good Lab Practices and Good Clinical Practices. Our auditors have experience in a variety of operations, from aseptic fill to blood fractionization.
Our Foundation
PharmaSys began as computer validation firm and remains a leader in the field. We can assess your computer systems, or proposed computer system, against predicate rules (cGMP, GCP, GLP), GAMP and Part 11 then make sound recomendations for compliance.
Knowledgeable Professionals
PharmaSys provides remediation services for consent decrees, warning letters, FDA 483 observations, and customer generated compliance events.
Extensive Experience
We have developed and executed cleaning validation programs in multi-product facilities and understand the challenges of ensuring a consistent and effective cleaning program.
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Expert Guidance
We provide commissioning, start-up and qualification services for production facilities, including utilities, process equipment and control systems. Our projects have ranged from single systems to major renovations/expansions to complete biotech and pharmaceutical facilities. We have the capabilities and expertise to take your business to the next level.
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info@pharma-sys.com
(919) 468-2547
PharmaSys
Compliance Solutions
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