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Two sides of the coin: Proactive versus reactive compliance management

10 minute read

There is virtually no activity conducted by pharmaceutical and biotechnology companies that is not monitored for compliance. Requirements such as good laboratory practices, good clinical practices, and good manufacturing practices affect nearly every aspect of the discovery, development, clinical testing, manufacturing, labeling, marketing, and distribution of products. On top of this, there are also requirements to meet the Foreign Corrupt Practices Act (FCPA) and the United States Department of Justice (DOJ) guidelines and requirements.

If you were ever in the Boy Scouts, you would know all too well the motto, “Be prepared.” When it comes to compliance programs and their management, history has shown it is much better to be prepared and proactive with these programs than to be reactive and under pressure to meet some objective.

If you have ever been under pressure to respond to audit observations and remediate these to a timeline, then you will understand the benefits of proactive compliance management. This discussion explores the benefits of proactive compared to reactive compliance management. These represent two sides of the same coin. The target is to establish and maintain compliance to a particular standard to avoid costly regulatory action, but how companies get there can profoundly affect the result and the company’s culture.

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