Regulatory Compliance & Life Sciences
Q: Can ASG provide FDA software validation support?
A: Yes. Given a set of requirements, we can develop the test procedures necessary to validate the requirements, and perform all testing as well.
Q: What can ASG do for Pharmaceutical Manufacturers?
A: In the pharmaceutical manufacturing environment ASG can provide expertise in manufacturing control and e-signature (21 CFR 11) applications. We can also provide independent verification and validation (IV&V) where corporate policy or the FDA demands it.
Q: How can ASG help me further my medical device development and assist in getting the device to commercialization sooner?
A: ASG has been involved in several medical device projects from product inception through requirements specification, design, the review process, debugging and testing, 501K submission, clinical trials, and product validation. To a great extent we can provide help at the systems and engineering management levels as well, codifying pertinent documentation and developing standards, test procedures, and other documents as required by the regulatory process.
ASG generally acts as an adjunct to your existing engineering resources, especially for those companies that do not have significant software development expertise in an FDA-regulated development environment.