Computer System 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 a 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.
compliance.
system efficiency.
continuous improvement.
Featured Resources
Webinar
ADAMAS Consulting’s webinar, “GCP ICH E6 R3 Unveiled: Navigating the Evolving Roles of Sponsors and CROs,” provides invaluable insights into the evolving landscape of Good Clinical Practice (GCP) guidelines.
Guide
Blog
WITH ADAMAS YOU CAN ENSURE ALL ASPECTS OF REGULATED COMPUTER SYSTEM RISK HAVE BEEN EXPLORED, UNDERSTOOD AND REMEDIATED WHERE NECESSARY.
Our Views
RESOURCE
Infographic
Many system and software vendors claim that they offer “turnkey” or ready-made 21CFR11-compliant systems. However, due to the nature of the regulation itself, ready-made compliance simply cannot be delivered by vendors/suppliers.
Download our infographic to discover why – and how you can protect yourself from regulatory issues, reputational damage and fines.
Resource
CSC Webinar
At ADAMAS, we’re passionate about helping the businesses we serve with Computer Systems Compliance (CSC). But just what does that mean, and how has it changed over the years?
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