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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.

SERVICES BROCHURE
WE CAN ADVISE ON AND PERFORM THE FULL RANGE OF CSC AND IT PROCESS AUDITS, INCLUDING IT-SECURITY AND COMPUTER SYSTEM VALIDATION AUDITS AND 21CFR11 COMPLIANCE CHECKS

Featured Resources

For a deeper dive into the ICH E6(R3) guidelines, check out our latest expert insights.

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.

Watch Webinar

Case Study

Our latest case study highlights how ADAMAS Consulting supported a leading pharmaceutical company in proactively identifying high-risk sites during a global Phase III oncology trial—aligning with ICH E6 (R3) guidelines.

Read Case Study

Guide

In this free guide, we break down the most critical updates to ICH E6(R3)—and provide practical, inspection-ready strategies to help you stay compliant, audit-ready, and ahead of regulatory expectations.
Download Guide
WE ARE EXPERIENCED IN WORKING WITH EMERGING TECHNOLOGIES SUCH AS CLINICAL INFORMATICS, BLOCKCHAIN AND WEARABLE MEDICAL TECHNOLOGY.

WITH ADAMAS YOU CAN ENSURE ALL ASPECTS OF REGULATED COMPUTER SYSTEM RISK HAVE BEEN EXPLORED, UNDERSTOOD AND REMEDIATED WHERE NECESSARY.

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Your Data is Safe With ADAMAS

Learn how ADAMAS ensures industry-leading data privacy and cybersecurity compliance through robust policies, secure platforms, and expert oversight—protecting clients against evolving risks.
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.

Download now
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?

Watch now

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