FDA-regulated firms seek to utilize computer systems to gain a competitive advantage in the marketplace by reducing costs and/or reducing time to market for their products. At the same time, these firms need to meet regulatory requirements (by demonstrating evidence of control) for the development, use and oversight of their systems. QA Edge will help our clients reduce their regulatory risk by supplying quality support personnel who have been effectively trained in the best practices of quality assurance and project management as it relates to the FDA mandates of PART 11.
Project Management Services
QA Edge's project management services combine our computer systems validation and regulatory compliance expertise with practical project management techniques. We offer practical project management solutions that bring regulated processes into compliance efficiently and economically.
System Validation Services
The Pharmaceutical and Medical Device Manufacturing industries rely heavily on computer systems to automate and control processes in virtually all facets of their business. Research and development, clinical trials, manufacturing, distribution, and drug safety monitoring all require effective processing, analysis, dissemination, and retention of massive amounts of data that is regulated by the FDA and foreign regulatory bodies. Technologies, used to automate these processes, are carefully scrutinized by the FDA and are subject to strict regulatory standards.
QA Edge Computer Validation Consultants provide expertise to assist clients in meeting the high standards for regulatory compliance established by the FDA. System Validation service offerings include validating individual computer systems, computer systems validation staff augmentation, IS/IT Quality System development consulting, and IS/IT Quality System Management Services.
Testing Services
One of the keys to good computer systems validation is demonstrating through documented evidence that systems fulfill the requirements for which they were designed. QA Edge consultants are experts in planning, executing and documenting testing efforts. Our experts assist clients in testing in existing software development/validation methodologies and in developing new strategies for efficient and thorough testing of computer systems. We can provide testers that are trained in automated testing tools (Mercury, Seque, Rational, and Compuware).
Compliance Assessment Services
Our validation consultants perform third-party audits of vendors to assess control over design, testing and customer support. We have also performed audits of CRO's to assess control over their systems and their ability to meet the guidelines proposed by sponsoring pharmaceutical companies.
Business Consulting Services
Our trained business analysts can accurately capture, document, and manage requirements, which can reduce project delays by 50% and lead to better compliance activities throughout the life of the project.
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