Avoiding 5 Pitfalls in Pharma Compliance

March 3, 2022

Pharma compliance is a tricky process, full of strict requirements. MasterControl’s Regina Fullin details 5 mistakes to avoid to get products to market without a headache (or less of one). A company’s quality unit, Fullin writes, is no good if it isn’t empowered and subject to the whims of upper management. Therefore, good documentation using a digital quality management system is essential. Likewise, weak investigations can sink chances of market success.

According to Fullin, “When you mess up, fess up. Investigations are a pharma company’s way of demonstrating that their top priority is a commitment to integrity. Sometimes pharma companies become so concerned with data integrity, it amounts to no integrity at all; and this is especially unfortunate because it also represents myriad lost learning opportunities. Companies that punish nonconformities create incentives to hide mistakes, rather than to bring them out in the open and fix them. When an organization commits to integrity, failing or nonconforming products and/or processes are treated as an opportunity to make a performance improvement and this leads to higher quality standards for their pharmaceuticals, and better results for consumers.”