21 CFR Part 11 compliance

DSG is fully compliant with 21 CFR Part 11, follows CDISC standards and is ISO/IEC 27001:2013 certified

21 CFR Part 11 compliance applies when using a computer system to create, modify, transfer or store an electronic representation of any information or process that is regulated by the Food and Drug Administration (FDA). Our interpretation of 21 CFR Part 11 is conservative and expansive.

DSG is fully compliant with 21 CFR Part 11, and employs personnel responsible for managing the dynamic nature of these regulations. DSG has met the 21 CFR Part 11 requirements according to multiple auditing teams deployed by top pharmaceutical companies and contract research organizations with expertise in the system validation and compliance area.


CDISC Standards

DSG’s eCaseLinkTM fully integrates with all types of vendors including Central Laboratories, eDiaries/ePRO, Specialty Laboratories, IVRS, CTMS, ECG Providers, CT Scans & MRI providers, Topographies & Radio-graphics providers, Safety systems, EMR, and Medical Device Output. eCaseLink facilitates the seamless exchange of data to all systems within the clinical study, in real time.


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DSG has a dedicated group of project managers and trial developers that maintain CDISC standards on all of our eClinical software applications. Although CDISC standards are currently not required on submissions to the FDA, DSG continues to promote the use of these standards and provides consulting to our clients whenever necessary to ensure compliance.


ISO/IEC 27001:2013 certified

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DSG is also a ISO/IEC 27001:2013 certified organization. ISO/IEC 27001:2013 specifies the requirements for establishing, implementing, maintaining and continually improving an information security management system within the context of the organization. It also includes requirements for the assessment and treatment of information security risks tailored to the needs of the organization.

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