Enterprise Level Change Control: A Life Sciences Business Imperative

By Sparta Systems, Inc.

Drug and medical-device manufacturers spend hundreds of millions of dollars to gain regulatory approval for their new therapies and therefore require significant returns just to break even. Add to that, the strict guidelines they must follow to ensure quality production for each and every unit and you can see why manufacturing consistency is a business imperative.

When internal or external forces challenge production standards, related processes, specifications or even critical documentation, controls must be put in place to ensure that product quality is not compromised. People's lives and the manufacturer's reputation can be at stake, and product irregularities simply cannot occur.

According to the United States Food and Drug Administration (FDA), "Change control is a complex process. Inadequate change control exposes a company to product liability actions, results in product recalls, causes internal confusion, and is a serious violation of the Quality System (QS) regulation."

Best practices and industry standards, as well as governmental regulations, demand that companies ensure adequate control over change management. Change control systems must guarantee consistent procedures and informed decision-making by qualified individuals as well as assure traceability back to the justifications behind the change process itself.