Wednesday, October 29, 2008

Only 59% of Pharma Companies...

Own Dedicated Compliance Departments, According to Research by Cutting Edge Information

Can this possibily be correct???...

A stand-alone Quality function is a direct requirement of federal law governing GMP activities...21CFR etc etc etc

I'll have to download the report and read it...that's's so questionable, I'll take the time to read it...

A new study by business intelligence firm Cutting Edge Information finds that only 59% of pharmaceutical companies currently own dedicated departments for compliance. The study, "Monitoring and Ensuring Pharmaceutical Compliance," highlights the growing need for creating a dedicated compliance department.

With only 59% of pharma maintaining a dedicated department for compliance, there are still a healthy percentage of companies who remain vulnerable to unforeseen regulatory changes. Building a strong compliance management team will give the staff the necessary power to effectively manage their internal clients' changing needs.

Maintaining a dedicated compliance department also signals to outside agencies that the company takes regulation seriously. Giving an outward appearance of a company willing to police itself goes a long way in the court of public opinion. The damage done by a compliance misstep can take a long time to recover from -- both legally and in the eyes of company stakeholders.

link to full article

link to report download

1 comment:

AdamB said...

Hi there,

As a Cutting Edge Information researcher, I wanted to clarify the press release that you're referring to. When our press release referred to 59% of pharmaceutical companies owning a dedicated compliance function, we were not referring to the quality control function that each company is required to have. The report you referred to concerns regulatory compliance groups. Essentially, it's a more narrow application of a legal team that monitors compliance protocol, such as compliance to OIG standards or any other agency that regulates pharmaceutical commerce. These groups often have Chief Compliance Officer heading their teams. These are not the QA/QC teams that monitor drug safety and compliant manufacturing protocols.

I hope this provides some clarity

-Elio Evangelista