Page 14 - ADAMAS Brochure

Computer Systems Compliance Practice (CSC)
Computerized systems and new IT-driven clinical applications are now an everyday part of the R&D process. If these systems aren’t managed appropriately, they
can represent significant regulatory risk to critical data, the integrity of essential documents, and the security of your network and applications.
ADAMAS’s CSC experts can work with you to ensure that your organization and vendors have a robust System Development Life Cycle (SDLC) in place, or to design and implement an entire SDLC for your organization. We can help you make sure that the range of validation audits your organization performs adds value, satisfy regulatory expectations and identify the issues that matter. We can do this by conducting audits
on your behalf, both internally and/or at your vendors’ facilities.
Reflecting recent increases in the sophistication and prevalence of networks and applications, it’s now a common regulatory expectation that organizations also have a comprehensive program of CSC process audits, in addition to validation audits.
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