Compliance to Pharmaceutical Organizations: Importance of 21 CFR Part 11

Today's world of biotech and pharmaceutical business is driven by a need to manage information digitally. The benefits from such a shift in corporate ideology have been well documented. What gets less attention, is the obstacles that mark the way of dependence on new technology. The Food and Drug Administration has picked up on this switch and implemented compliance guidelines to ensure these new methods are secure and traceable. While those who must deal with the FDA often have nothing but bad things to say, they represents the same necessary service as the IRS.

Let me start off by saying that working in biotech, Part 11 compliance is a serious matter and more difficult than people think. In a small organization with limited financial capabilities, we have yet to be able to become fully compliant. 21 CFR Part 11 compliance has some specific points of emphasis that relate it more to bio/pharma companies than others. It is a tedious process that requires money, time and attention to detail.

Ensuring the authenticity, integrity, and confidentiality of electronic records - everything in a pharmaceutical company is documented. This means extremely sensitive data like patient information, batch records, formulation methods for products, clinical data, etc. all needs to be appropriate controlled. Because often we are dealing with a product that interacts with humans, integrity is vital. The FDA needs to know the document they approved for a formulation method is unaltered and authentic.

Nonrepudiation of electronic signatures - electronic signatures serve the same purpose for electronic documents that physical signatures serve for physical records. Every single document goes through a grueling review/approval process. Before a document is finalized, signatures from appropriate approvers must be obtained. It is important to guarantee the authenticity of these signatures for integrity of the document as well as personal responsibility.

Audit trials for electronic signatures ensure the authenticity and integrity of these signatures as well as the documentation they are on. It cannot be said enough that absolutely everything in a bio/pharma company is documented when dealing with the FDA. And this means everything. Believe it or not, it is often better to complete a task poorly and adhere to documentation than to complete it the correct way and deviate.

In the end, process owners and executives are left with important decisions to make. To embark down the technology trail in pharma or biotech opens a new can of worms. Costs up front can be astronomical and often are the deterring factor. But those who take a much longer-term view of the situation understand the need to move away from old physical file systems and on into the digital wolrd. It may seem like the FDA is doing everything to prevent this, but they are in fact supporting a new high-tech world. So read up on the latest compliance documentation. The initial glance may seem overwhelming, but then so are the many technological advances we have benefited from.