General

Yes. Given a set of requirements, we can develop the test procedures necessary to validate the requirements, and perform all testing as well.
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.
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.
Applied Sciences Group is committed to ensuring that upon request your web development project is accessible to everyone, including people with disabilities. To meet this commitment for our clients, we design for the requirements of Section 508 of the Rehabilitation Act. Section 508 requires that individuals with disabilities, who are members of the public seeking information or services from us, have access to and use of information and data that is comparable to that provided to the public who are not disabled, unless an undue burden would be imposed upon us. Section 508 also requires us to ensure that federal employees with disabilities have access to and use of information and data that is comparable to the access and use of information and data by federal employees who are not disabled. ASG is striving to improve our website experience for all our visitors. If you use assistive technology (such as a Braille reader, a screen reader, TTY, etc.), and the format of any material on our website interferes with your ability to access the information, please contact us for assistance. Indicate the nature of your accessibility problem, the preferred format in which to receive the material, the requested material, and your contact information.
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Applied Sciences Group, Inc.