Merging Quality Systems

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Company growth is often achieved via acquisition an merger. Consolidation always brings challenges and the quality systems are no exception. Since the FDA dies not prescribe the details of how a quality system should be structured, each company must create their own system. The net result is little uniformity in the quality systems of different companies.

The issues are somewhat different when a much larger company is acquiring a small or startup company.

The quality systems of a large company are typically mature: extensive, well-detailed, and prescriptive, while the one at the small company is minimal, usually not consisting of much more than policies. This leaves a lot of room for the small company's quality system work product, including manufacturing and design control documentation, not being up to the large company's standards, or at least being in different formats. In extreme cases, it may be necessary to repeat some aspects of ongoing development projects, for example to obtain statistically valid data.

When two companies of approximately the same size merge, the the main issue is usually which company's SOPs and formats to use, to what degree will it be necessary to reformat documentation, and to what degree can documentation and other work product be "grandfathered in."

AlvaMed has had experience in assisting companies through these oftentimes difficult transitions. If you are facing such a situation, allow us to show you how we can help, from identifying creative ways of bridging the gaps to supplying experienced professionals to work alongside your team to do the work necessary to bring things up to par.

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