Quality-System
Integration

In a constantly-changing business environment, manufacturers of both medical devices and pharmaceuticals are in constant flux. In a merger/acquisition situation, a new company with a an entirely different quality-system will need to integrate its processes and procedures with the parent company. This task has the potential to be very time-consuming for the parent organization, but is required because standards dictate that executive management is accountable for the quality-management system.

Integration is part of the assimilation process to ensure management applies consistent criteria consistent when evaluating quality and business risks. Failure to integrate could lead to misapplication of risk estimates under two systems that may lead to faulty decision-making, or even compliance gaps.

Compliance Team’s approach is to involve management from the beginning with the end in mind. The goals for assimilation are paramount, and there is no “one size fits all” approach. Some companies merge for organizational reasons (for example, to acquire an organization with proficiency to handle tasks that had previously been outsourced) and others merge for technological ones (for example, to combine a device platform with novel chemistry to yield a revolutionary new product). The integration plan needs to stay true to the purpose.

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 the acquired company access to the parent company’s 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. Another example would be the need to re-evaluate risks in a consistent manner to parent company criteria.

Implicit to quality-system integration is the split-up of a quality-system during a divestiture. Divestiture is an opportunity to simplify previously bureaucratic processes now that the organization become more nimble and agile. SOPs may be able to be cut to a fraction of their original length simply by omitting or simplifying requirements that no longer apply to a smaller business entity.