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Pharmaceutical ACE experience in the pharmaceutical industry continues to expand and develop in a wide range of applications. Batch Reactor, Fermentation and Biotechnology projects have been major areas of project work for us over the years. Companies involved with system validation and 21 CFR Part 11 compliance support have received significant support from ACE over the last couple of years. We are experienced in S88 compliant batch control, reporting and data management systems. We have an excellent background implementing continuous and sequential control systems as well as SCADA communications and networking on fermentation and bio-reaction vessels, including the design and integration of SIP and CIP systems. Our validation technical services include experience in preparing cGMP compliant computer system qualification documentation on pharmaceutical projects where Functional Requirement Specifications, Detailed Design Specifications, Master Test Plans, Installation Qualification Protocols (IQ) and Operation Qualification Protocols (OQ) are required. |