Integrated Quality System and its Implementation

Pharmaceutical manufacturers having constantly changing business strategy and in a merger or acquisition situation, a new company with an entirely different quality system will need to integrate its processes and procedures with the parent company. Integration is part of the assimilation process to ensure management applies consistent criteria when evaluating quality and business risks. Failure to integrate could lead to misapplication of risk estimates under two systems, and may lead to faulty decision-making, and even compliance risk.

The assessment will determine which quality subsystems can be easily integrated. Examples include training the acquired company on the parent company’s policies and procedures, and/or by granting acquired company access to parent company online tools. The assessment will also identify needs for detailed review, and potential remediation. An example of this would include conversion of paper records into an electronic system, when an online form may have requirements for information that was not required in the paper-based system.