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eSign's 21 CFR Pt. 11 Module is a free module included with an Enterprise licence, and ensures that your organization meets FDA regulations for the use of electronic signatures.
eSign offers a 21 CFR Part 11 module designed to ensure your compliance with the US FDA's electronic signature regulations under 21 CFR Part 11.
Our validated Part 11 module incorporates essential eSignature features, including authentication, reasons for signatures, and signature manifestation. These capabilities guarantee regulatory compliance while streamlining the signing process, making it more efficient, cost-effective, and convenient for everyone involved.
Simplify compliance with eSign.
Create accurate and comprehensive record copies
To comply with 21 CFR Part 11, a system must be capable of generating accurate and complete copies of records in both human-readable and electronic formats, suitable for FDA review, inspection, and copying.
eSign enables authorized users to retrieve and export digitally signed documents along with a system-generated digital audit history of signing events and an exportable Certificate of Completion. Additionally, all documents are digitally signed by eSign, providing an open standards method to verify document integrity.
Manage and restrict who can access the system and documents.
21 CFR Part 11 mandates that systems must implement authority checks to ensure only authorized individuals can use the system, electronically sign records, access operations or computer system inputs/outputs, alter records, or perform specific operations.
eSign upholds this requirement by maintaining a comprehensive list of users, roles, access rights, and permissions within the system. User identification is based on a combination of email address and password, with the password serving to authenticate access to the system.
Additionally, eSign offers optional advanced authentication methods to further validate the identity of all transacting parties. These methods include one-time passcodes sent to mobile devices, knowledge-based authentication, and PIN protection on envelopes.
Watch the video tutorial.
“Using eSign has made our tenancy completion processes so simple. You don’t have to be technically savvy to be able to use the platform and it doesn’t draw on any other ICT resources. Our tenancy agreements and documents are signed within minutes and we’ve even had tenants’ comment on how easy it is to use as a signer which is fantastic.”
“We have seen significant improvements in our pharmacy service efficiency since implementing E-Sign. The platform is user-friendly and has allowed our team to securely and reliably provide prescriptions for crucial patient medication, minimising the risk of supply disruption and saving valuable time. Collaborating with E-Sign has been an easy process, Desi and Luke have always been professional and approachable to offer support when needed.”
“We are very proud and thrilled to be working with the eSign team, creating a truly digital and revolutionising management tool for controlled drugs in a post-pandemic world. The benefits to the clinical and pharmacy teams are huge and drives greater legislative and regulatory confidence and safer and efficient patient care.”
“The tools are very easy to set up and intuitive to use. When we encountered issues, the eSign team was agile enough to respond, usually on the same day. The copy template feature has made setup with new customers much easier.”
“The University of Oxford have appointed eSign UK Ltd. as their preferred electronic signature platform. Esign quickly guided departments on the most cost-effective and efficient route offered, providing continued support to ensure contracts were completed and deadlines met.”
“The law supports the use of electronic signatures, and eSign is an essential tool for any business wishing to enhance customer experience and accelerate revenue. Esign is incredibly user-friendly, and using it has been a very positive experience both for me and for my clients.”
“Esign has transformed our operations at Beyondly. Integrating eSign into our systems was relatively straight forward and has massively improved customer and team experience. As a Bcorp organisation we place high value on our environmental impact and since inception, eSign has represented a 31.46kg saving of CO2 entering the atmosphere.”
“Esign is an invaluable tool that assists us in keeping track of our legal matters. It gives us full control of the document journey and has greatly improved signature capture and document turnaround times.”
“Working in the regulated financial and medical markets we need a quick secure and economical signature process. Esign gives us all of these.”
“One thing which sets eSign apart is their flexible signature packages, allowing flexibility in both pricing and usage to provide the best solution for the organisation. The GPA has been very well looked after by our eSign account manager and we look forward to continuing our relationship with them.”
Ensure you’re never held back by paper-based and manual processes with our digital signature and document platform.
Once your documents have been digitally signed, you can easily store them securely within the eSign platform or download them to file in your chosen file structure.
eSign's platform is ISO 27001, ISO 9001 accredited and is 21 CFR Part 11, HIPAA, eIDAS and EMA compliant.
Maintain compliance with a full audit trail and a transparent process, easily retrieving data at any time.
Streamline your processes by sending all of your digital documents securely via eSign and allow users to sign documents in a matter of minutes.
Validate the identity of all transacting parties, such as one time passcodes and knowledge-based authentication.
For the FDA to accept eSignatures in place of handwritten signatures, they must meet a specific set of criteria.:
Other requirements also include:
For the technical details of how our platform can assist your organisation with maintaining Part 11 compliance, download our 21 CFR Pt. 11 Technical Guide or get in touch with our Digital Transformation team.
Any organization that is regulated by the FDA or carries out activities that are related to FDA-regulated products are required to comply with 21 CFR part 11. These often include but are not limited to the below industries:
If you fail to comply with the regulation, you may face severe consequences, including:
