have trust in your DATA and systems
 

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.

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

MORE REASONS TO WORK WITH ADAMAS

GLOBAL CAPACITY

ADAMAS has conducted thousands of GxP audits in over 100 countries for over 750 international clients. We are committed to providing all our clients with the highest level of service in every country. With offices in three continents, our global capabilities allow ADAMAS to provide coverage for a wide range of healthcare clients, operating internationally.

PUTTING PEOPLE FIRST

ADAMAS has a growing team of full-time, employed permanent consultants, each with an average QA experience of over 10 years, based in three regional offices. With staff based across four continents not only is ADAMAS able to provide coverage for a wide range of clients, we are able to ensure travel for our staff is safe, responsible and practical.

IT AND Infrastructure

ADAMAS partners with the best and most-respected IT suppliers to serve our customers better. We utilize cutting-edge technology including end-to-end encrypted document sharing, ADAMAS audit metrics and benchmarking data so we can provide our clients with efficient and secure service with actionable insights.

YOUR DATA IS SECURE

ADAMAS has comprehensive measures in place to ensure that the data we collect is safeguarded to every extent possible and reflects the ‘state of the art’ GDPR. We also have a number of internal compliance steps to ensure that data is protected from external threats, including independent penetration testing.

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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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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