21 CFR Part 11 Module

eSign's 21 CFR Pt. 11 Module is a free module included with an Enterprise licence, and ensures that your organisation meets FDA regulations for the use of electronic signatures.

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E-Sign 21 CFR Part 11 E-Signatures

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E-Sign’s Compliance with 21 CFR Part 11

eSign provides a 21 CFR Part 11 module that ensures you comply with the US FDA’s 21 CFR Part 11 electronic signature regulations.

Our validated Part 11 module includes specific eSignature features for authentication, reason for signature, and signature manifestation. These tools ensure regulatory compliance while making the signing process faster, more cost-effective, and convenient for all parties involved.

1.1 million
documents processed per month
20,000
new signers per month
400,000
envelopes sent per month
1.1 million
documents processed per month
20,000
new signers per month
400,000
envelopes sent per month

Simplify compliance with eSign.

How is eSign Compliant with 21 CFR Pt. 11?

Our 21 CFR Pt. 11 module supports compliance through our leading electronic signature platform. The core elements of our 21 CFR Part 11 eSignature module include:

  • Creation of a new 21 CFR Part 11 account
  • Honour receipt signing order
  • Controls for open systems
  • Role-based access and multi-factor authentication 
  • Reason for signature (signing reason)

These features help to ensure that life science organisations are compliant with the regulation whilst using secure eSignatures, to streamline the process for completing important documents in a faster, more cost effective, and efficient way.

For more information, please download our Compliance Validator.

Compliance Validator
Simply 21 CFR Pt.11 Compliance with Electronic Signatures

Generate accurate and complete copies of records.

Physical & Electronic Documents

Part of the requirements for compliance with 21 CFR Pt. 11 is that the system must have the ability to generate accurate and complete copies of records in both human readable and electronic form, suitable for review and inspection and copying by the FDA.

eSign provides the ability for authorised 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. All documents are also digitally signed by eSign, which provides an open standards method to verify document integrity.

Generate Physical & Digital Documents 21 CFR Compliance

Control who can access the system and documents.

Restricted Access & User Permissions

21 CFR Part 11 states that the system must use authority checks to ensure that only authorised individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand.

eSign maintains a list of users, roles, access rights, and permissions within the system. The combination of email address and password identify a user, and the password is used to authenticate access to the system.

We also provides optional advanced authentication methods to validate the identity of all transacting parties, such as one time pass codes sent to mobile devices and knowledge-based authentication as well as PIN protection on envelopes.

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eSign 21 CFR Part 11 Module

Maintain compliance with FDA regulations by sending envelopes from an eSign 21 CFR Part 11 account. Recipients have the ability to state their reason for signing, as well as authenticating their identity before accessing the envelope.

Watch our video tutorial to see just how easy it is to send envelopes from an eSign CFR Part 11 account.

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Testimonials

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Mid Devon District Council

“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.”

Lisa Harber | Team Leader 
Portsmouth Testimonial

Portsmouth University Hospitals

“E-Sign has proven to be a fantastic system that has had an important positive impact on our homecare prescription services. It has enabled us to significantly reduce the administrative burden on clinicians, creating a lean process that allows prescriptions to be signed and completed within minutes rather than days. The combination of E-Sign and our new prescription management platform has transformed our workflows, allowing us to improve the service we provide. A patient’s health is at the end of each document and E-Sign has helped us ensure that every document is processed quickly, securely, and accurately.”

Raghu Mamullapally | Lead Pharmacist Homecare Services
Leicester Hospital Case Study

University Hospitals of Leicester

“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.”

Amy Page | Kidney Pharmacy Team
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University of Oxford

“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.”

Purchasing Department | End User
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Paratus Law

“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.”

Simon Arthur | Owner
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Beyondly

“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.”

Emily Rice | Operations Manager
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National Clinical Homecare Association

“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.”

National Clinical Homecare Provider | End User
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Slater Heelis Solicitors

“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.”

Slater Heelis Solicitors | End User
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Morgan Ash

“Working in the regulated financial and medical markets we need a quick secure and economical signature process. eSign gives us all of these.”

Andrew Gething | Managing Director
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Blue I Properties

“Can’t recommend esign enough. It is quicker, easier and cheaper to use than many of their competitors.  The detailed Document History provides useful evidence and proof of when your document was created and signed.  Their team members are extremely knowledgeable of the systems, friendly and professional.  All in all, an amazing product at a very competitive price.”

Debbie Collins | Lettings Administrator
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Government Property Agency

“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.”

Government Property Agency | End User
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10-100

“The solution was simple to use, has a great management portal, and the price met our expectations. We now use the product for our own internal use and have recommended and deployed it into our customers when we get requests for signature solutions. eSign’s ongoing support is excellent, and they are continuously improving and developing their solution.”

Paul Visagie | IT Consultant
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Cambridgeshire County Council

“eSign has brought both time and efficiency benefits to our department since we started using the platform two years ago. It is easy to use and they have useful training videos available which have been helpful for training our team on how to use the platform and its features.”

Wendy Ballard | End User
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Churchill Support Services

“Using eSign has significantly reduced the time it takes to send and receive contracts which means we close deals quicker. I especially like how you can redirect and edit documents without creating new envelopes and keep track of which contracts are pending signature as an admin. As an environmentally friendly business, it’s helpful to see how much carbon we are saving with the carbon counter. I would definitely recommend eSign to a business who is looking to close deals faster.”

Katie Butcher | Client Relationship Manager
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University of Salford

“We use eSign at the University of Salford to issue copyright declaration forms when supplying copies of material to users of our archives. We used to issue the forms as attachments to emails, but users found it difficult to sign and return the forms, especially if they didn’t have a printer. Sending the forms using eSign has made it much easier and quicker for our users to sign and return the forms. From our end it is simple and straightforward to issue the forms via eSign and we get a notification when they have been completed.”

End User | University of Salford
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Polden Bower

“We wanted a user-friendly system that would comply with finance policy, manifest maximum engagement from all Signatories, and had the capability to offer more as we grow as an organisation.  eSign fits the bill on all fronts for us from affordability, cost savings, accessibility and functionality perspectives, right through to tried and trusted customer service, support and data security.  We spent our first year on the Business Plan to embed this new way of working into our processes and we are now ready to roll out eSign access to other Central departments as we upgrade to the Enterprise subscription.  The user guides, chat facility, training offer and support provided by eSign is all really helpful and the team are always responsive when we get in touch.  It’s also reassuring that the Data Centres are in the UK and are managed by eSign.”  

Alison Sanders | Executive Finance Officer
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Boon Brokers

“E-Sign has significantly helped our operations at Boon Brokers. Previously, clients had to manually print, sign, and scan documentation back to us. With the help of E-Sign’s API, we have managed to integrate the system into our software. This now enables all clients to easily E-Sign our fact-finds within a matter of clicks via e-mail. This has significantly improved the efficiency of our business. Thank you, E-Sign.”

Gerard Boon | Managing Director, Boon Brokers
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Thula

“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.”

Adele McAllister | Manager
Hessington Health Testimonial

Hessington Health

“Hessington Health is a busy national health screening and occupational health practice with over 18 independent schools and over 10,000 staff members. The challenge we have faced is reminding employees to sign consent forms before we release the reports to their employers. This is an incredibly time consuming process. E-Sign has offered us the perfect solution. The online dashboard allows us to track the consent forms in their journey, Set reminders and have a safe place to store the completed forms. This has saved us an immense amount of time and improved our governance in this area. It also allows the user to create bespoke forms meaning any organisation from any sector will be able to utilise this package.”

Harjeev Rai | Medical Director

Benefits of eSign for 21 CFR Pt. 11 Compliance

Increased Efficiency
Improve Operational Efficiency

Ensure you’re never held back by paper-based and manual processes with our digital signature and document platform.

Digital Signature Certificate
Simplified Document Management

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.

Compliant Documents
Compliant Documents

eSign's platform is ISO 27001, ISO 9001 accredited and is 21 CFR Part 11, HIPAA, eIDAS and EMA compliant.

Advanced Audit Tracking
Supported by Full Audit Trail

Ensure compliance with a full audit trail and a transparent process, easily retrieving data at any time.

Faster Document Turnaround
Faster Completion

Streamline your processes by sending all of your digital documents securely via eSign and allow users to sign documents in a matter of minutes.

Multi Factor Authentication
Advanced Authentication

Validate the identity of all transacting parties, such as one time pass codes and knowledge-based authentication.

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Technical Checklist

  •  All signed documents are supported by a digital signature certificate.
  •  Ensure high standards of security and compliance with a full audit trail.
  •  Require recipient to be authenticated to access envelope.
  •  Allow account administrators to specify password criteria.
  •  A unique digital fingerprint is generated with each new signature.
  •  Download audit trail and all enclosed documents within the envelope

Frequently Asked Questions

How does eSign ensure compliance with 21 CFR Pt.11?

eSign has a 21 CFR Pt. 11 validation module that supports compliance through our leading electronic signature platform. 

Our validated Part 11 module includes specific eSignature features for authentication, reason for signature, and signature manifestation.

These tools ensure regulatory compliance while making the signing process faster, more cost-effective, and convenient for all parties involved.

For more information, get in touch with our Digital Transformation team.

What are the 21 CFR Pt.11 requirements?

In order for the FDA to accept eSignatures in place of handwritten signatures, they must meet a specific set of criteria:

  • The printed name of the signer
  • A unique user ID
  • The date and time of the signature
  • Digital adopted signature
  • The meaning of the signature (“signing reason”)

Other requirements also include:

  • Each eSignature must be unique to only one individual and not reused by anyone else
  • The identity of the signer must be verified before the electronic signature is applied
  • There must be additional evidence from the e-signature provider that certify that the signature is legally binding
  • If the signature is not based on biometrics, it must use two distinct components for identification such as an ID code and password
  • The eSignature platform used must have safeguards in place to prevent unauthorised access to documents and stop unpermitted use of identification codes and passwords

Where can I get the technical details of eSign's Part 11 support?

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.

Who is required to be compliant with 21 CFR Pt.11?

Any organisation 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:

  • Food and beverage manufacturers
  • Cosmetic manufacturers
  • Clinical laboratories
  • Medical device manufacturers
  • Pharmaceutical companies
  • Contract research and manufacturing organisations
  • Biotechnology companies

What are the benefits of eSign for life sciences?

There are several benefits of using E-Sign for life science organisations, such as reducing cycle times for reviews and and approvals. Life science companies typically involve various complex processes which require collaboration with internal and external stakeholders. The use of traditional paper-based methods of using and exchanging documents has become outdated for these technological industries and can slow down product development. 

With E-Sign, documents can be created, signed, and sent in just a few clicks, significantly reducing turnaround and improving communication for life science teams. This is also beneficial if your organisation has stakeholders based in different locations as E-Sign documents can be securely accessed from any device in any location. 

Another important benefit of E-Sign for life sciences is that there is a reduced risk of human error. Life science is a precise industry that requires a high level of accuracy and through our impressive document management system features, you can implement automation in your workflow and mitigate mistakes as much as possible. 

By maintaining compliance with 21 CFR part 11, E-Sign has become an industry leading provider for life science organisations. We can support companies with an effective digital platform that can meet and exceed their requirements both in terms of regulations and legality, and their internal processes in improving overall operational efficiency. 

What happens if you don’t comply with CFR Pt.11?

If you’re required to comply with the regulation and you are not, you can face serious consequences such as:

  • Warning letters
  • Initiation of disqualification proceedings
  • Notices of inquiry
  • Criminal fines
  • FDA-regulated products seized
  • Recalls
  • Criminal prosecution
  • Retention orders

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