Pharmaceutical

E-Signatures in Regulated Industries

In a regulated industry like the life sciences, signatures carry a lot of weight. For example approving the release of medicines, new manufacturing contracts, changes to patient information leaflets. The signature verifies the date and person responsible for a document. E-Signature tools remove the need to print multiple page documents which then require storing. Often the related signature will only be required on the first or last page. With E-Signatures the signature is permanently linked to the whole document. It cannot be removed or replaced without re-creating the document.

The security of the E-Signature process requires a check on the validity of the signature itself and of the individual it is linked to. It is relatively simple to photograph a signature or create one in a vector drawing program then embed the image into a PDF document. While acceptable for some purposes it is not a strong enough solution for business especially in regulated fields such as Life Science that and require comprehensive audit trails and documented assurance through computer system validation processes. The E-Signature not only needs to be embedded in the document. The integrity and legitimacy of the signature needs to be verifiable and any changes in signatures and approvals need to be logged.

Solutions:

DocuSign and Adobe Sign are industry recognised E-Signature platforms. Both are built to comply with 21CFR Part 11 (the USA FDA audit trail process)and EU Annex 11 (the EU equivalent). In both cases the notation 11 refers to the processes applied to electronic documents.

DocuSign market their 21CFR compliant version the ‘Part 11 module’. This is an evolution of previous DocuSign tools. Certain configurations are restricted and others have a visual identification to show that changing the configuration could impact 21CFR compliance.

Adobe Sign contains a Bio-Pharma configuration section that allows you to configure Adobe Sign to meet 21CFR / EU Annex 11 regulations.

Validating E-Signature Software:

The first step as with any computer system validation project is to understand your user and functional requirements. There is no one size fits all, it comes down to your use case(s). The beauty of Electronic Signatures is that they can replace almost any paper based document approval process.

Once you understand your requirements you should perform a quality risk assessment and vendor assessment to understand what impact the E-Signature platform will have on your organisation and ensure the vendor has the necessary controls in place to meet your requirements.

Once you know the risks and have defined your requirements you can start the process of configuring and testing your E-Signature platform. The vendor will provide you with some documentation and support however this is seldom enough to configure the system to its fullest. Particularly if you’re thinking of utilising more advanced features such as templates (reusable documents such as change request forms). Clearly security is a big part of any E-Signature platform. To simplify security we recommend integrating with the organisation’s identity provider, this will significantly improve the E-Signature experience and provide an added layer of authenticity.

What are the benefits of an E-Signature platform?

• Link a signature or approval to a whole document not just the pages signed off.
• Guarantee that a signature is linked to an organisation and individual.
• Enable work from anywhere, removing the dependency on printers.
• Reduce consumable costs such as paper and toner.
• Improve the carbon footprint of your company.
• Speed up the signature process in turn speeding up business processes.

Kindus E-Signature Validation Services?

Kindus has worked with several life sciences organisations to validate their E-Signature platforms. Our team of validation, security and technology consultants can deliver a fully configured and validated solution in a matter of weeks. We will support you to define your use cases and functional requirements to ensure the solution delivers value. Our validation consultants will work to your internal quality and validation procedures. We can also deliver bespoke training sessions and materials so that your employees are empowered to use E-Signatures to their full potential.

To find out how Kindus can help contact us today to speak with one of our validation specialists.

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