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Data Integrity Project QC Laboratories


Description Assignment
Because of rapidly developing data integrity requirements, MSD enlisted the help of Vivenics to assess the DI compliance of a variety of 30 computerized laboratory systems. After identifying DI gaps, interim controls had to be implemented to solve the high risk gaps. Furthermore, a program had to be started to remediate all systems with DI gaps and comply with data integrity regulations and guidelines.

Vivenics solution
A team of Vivenics experts with extensive knowledge of data integrity, computer system validation, lab systems and supporting IT solutions was formed. Working together closely with subject matter experts from the lab and quality assurance, a standard way of working was introduced to efficiently implement standard solutions as interim controls. Meanwhile, building on this experience, the program to remediate and upgrade the computerized laboratory systems was started.

DI assessments were completed within a limited timeframe, followed by short period of efficiently fixing the high risk deficiencies. In a step-by-step approach, starting with the high critical systems, the PC-based analytical systems were upgraded to fully comply with data integrity requirements. As the field of work was rapidly developing around us we kept a keen eye on new guidance and we adjusted course (retrospectively where needed) whenever appropriate.

Vivenics’ efforts to help MSD grow their DI compliance was not just limited to the strict boundaries of the project. In preparation for the audits the Vivenics DI expertise was instrumental to the success of passing DI criteria.

Vivenics is tenacious in achieving the goals together with the client.

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