QC2 performs audits of data management and EDC core applications as well as study specific configurations.

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We have audited a wide variety of IVRS/IWRS/IXRS applications, ranging from systems that are developed “one-off” for study specific use, to highly configurable, menu driven applications with little to no custom programming.

Audits include in depth assessment of the adequacy of testing of user requirements, ensuring that test cases include sufficient data to stress the system.

Testing of application user requirements relating to 21 CFR Part 312, 812, and 314, including reporting timelines, are also assessed.

The modules for triage and report management and tracking are emphasized, to confirm the application will facilitate timely safety reporting to regulatory authorities.

Data extracts and provision to biostatistical personnel, as well as archival and provision of final data to sites are assessed.

Application infrastructure, including the security, redundancies, and environmental safeguards are evaluated to confirm the system meets industry standards and regulatory requirements.

Compliance with 21 CFR Part 11 is also reviewed, including the infrastructure for the application.

QC2 has considerable experience auditing interactive voice response systems (IVRS), interactive web response systems (IWRS), or multi-modal platforms (IXRS).

QC2 auditors are aware of the validation needs particular to the application infrastructure, including hosted systems.

We understand the differing testing requirements for various data management platforms.

QC2 audits computer systems supporting clinical development, including data management systems, image tracking, management and analysis, blinded reading systems for clinical response, central electrocardiogram reading centers, and other specialized applications.