Understanding 21 CFR Part 11 compliance

Signatures are a critical component of important documents. In this era of globalization, where organizations and individuals do business across the continents, it makes sense to save time and resources on activities such as having to get signatures from relevant, important persons for accelerating the speed of business.

How does one authenticate signatures with the person when they are absolutely necessary for inking a deal or initiating a project is not available physically? This is where FDA 21 CFR Part 11 Compliance comes in. the FDA 21 CFR Part 11 Compliance is an FDA-set standard used to verify and validate electronic signatures for records pertaining to FDA-regulated industries. In other words, FDA 21 CFR Part 11 Compliance is a means to ensure that electronic signatures are authenticated as genuine.

Adherence to strict criteria

The criteria used by the FDA to validate electronic signatures are set out in FDA 21 CFR Part 11 Compliance. This standard relates to electronic and handwritten signatures that several FDA-regulated industries execute, and also to certain kinds of electronic records. Compliance with the strict guidelines of the FDA 21 CFR Part 11 Compliance standard confirms the verity of these signatures and electronic documents.

The aim of having strict standards as part of the core compliance with FDA 21 CFR Part 11 Compliance is to ensure that the documents which are electronically signed are genuine, safe and reliable. The logic of this standard is to give electronic signatures the same level of trustworthiness and authenticity as the physical one.

Towards ensuring this, the FDA has set standards, processes and criteria that several FDA-regulated industries consider too stringent. Some have even legally challenged the process, but there seem no signs of dilution of the standards required on the part of FDA 21 CFR Part 11.

Which FDA-regulated industries require FDA 21 CFR Part 11 Compliance?

The broad canopy of healthcare, pharma, life sciences and medical devices industries that the FDA regulates have to comply with the standards set out by the FDA 21 CFR Part 11. Some of these include:

  • Companies engaged in the manufacturer of medical devices
  • Companies in the business of development of biologics
  • Biotech companies
  • Manufacturers of drugs of a number of varieties and kinds
  • CROs

Business and activities that have exceptions to FDA 21 CFR Part 11 Compliance

Exceptions to FDA 21 CFR Part 11 Compliance relate to the filing format of filing. The point to bear in mind about FDA 21 CFR Part 11 Compliance is that it is applicable for only electronic format submissions made to the FDA. This means that FDA 21 CFR Part 11 Compliance is not required when a paper submission of a document is made in an electronic format.

The FDA requires retention of certain records to help it in tracing back food manufacturers. FDA 21 CFR Part 11 compliance is not required in such cases. However, the FDA requires these organizations to maintain the set documents in the prescribed manner to facilitate its search when the need for it arises.

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