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ROI CalculatorFDA 21 CFR Part 11 provides detailed information on developing and implementing a digital Quality Management System (QMS) in accordance with FDA regulations. Part 11 outlines how an organization can use electronic records, instead of paper and 'wet' signatures, for all project-related documentation.
If you either develop, test, manufacture, or manage life-science products that will be marketed through the FDA, you must comply with FDA’s regulations found in 21 CFR Part 11.
To comply with Part 11, organizations are required to use compliant electronic signatures in the review and approval processes of documented materials to ensure that each documented item is securely authenticated, traceable, and housed in a secure manner.
In addition to using compliant electronic signatures, organizations are required to ensure that all electronic records are securely created, maintained, stored, and managed in accordance with the requirements specified in Part 11. Part 11 provides details regarding the validation of systems, controlling access, maintaining audit trails, maintaining version history, and training personnel to effectively maintain the integrity and reliability of data through the entire lifecycle of the records.
Part 11 outlines in detail the requirements for using electronic signatures within a closed-loop QMS.
When using e-signatures, the name of the person signing, the date/time of the signature, and the meaning/intent of the electronic signature must be contained in an evolving and unchangeable audit trail.
Rules for the application, control and authentication of these signatures are extensive:
E-signatures must be unique to individuals
E-signatures must be password protected
Only administrators should be able to control the use of e-signatures in the system
Signatures must be authenticated in real-time when they are used
Approval must always be attributable to a specific individual
The signature cannot be removed once it is applied
To guarantee a digital signature is as trustworthy as a traditional hand-written signature, the part of the FDA rules about signatures contains very strict regulations regarding how to authenticate identity and prevent the signing of an electronic document from being falsified.
Currently, it is easier to sign a patient test result using hands than to sign that same document electronically using FDA regulations under Part 11.
The best and most financially feasible approach to complying with the requirements outlined in FDA regulations is to use an e-QMS's native e-signature software.
When the FDA published Part 11 for the first time in 1996, they were finally taking action to address the challenges presented by the digital age. The pharmaceutical and medical device industries relied on using paper documents and obtaining signatures from multiple individuals, slowing their operations down and making it difficult to have FDA audits performed on time.
Part 11 highlighted an increasing need for innovation within the manufacturing processes of the industry to allow for more rapid market entry of newly manufactured goods, through the use of digital tools. This is mirrored by many other countries’ desires for innovative products to be produced and sold. The EU has developed similar guidelines for the regulation of computerized systems utilized within regulated industries as specified in Annex 11 of the EU GMP guidelines.
