Zoho Sign controls for life science | 21 CFR Part 11 | EU GMP Annex 11

Zoho Sign controls for life sciences

Available in the Enterprise edition and enabled upon request

Today, life sciences companies are facing many challenges, which include improving patient/employee experience, reducing costs, and increasing overall efficiency by automating workflows while ensuring they meet the compliance requirements. With Zoho Sign, life science companies can automate document signing processes across a wide range of areas, such as:
  1. Clinical trials
  2. Manufacturing
  3. Sales and Marketing
  4. Legal and compliance
  5. Procurement
  6. HR and onboarding
In the life science industry, the terms electronic records and electronic signatures (ERES) and audit trails have specific implications:
  1. Electronic Records - Any combination of text, numbers, graphics, or audio in digital form which can be created, modified, and stored in a computer system
  2. Electronic Signatures - A compilation of characters that is authorized by an individual and is unique and tied to a specific person, and is the equivalent of a handwritten signature.
  3. Audit Trail - Set of records that provide documentary evidence of the activities, such as when electronic records were signed, who signed them and who sent them. All electronic records and electronic signatures shall be date and time stamped and will require an audit trail.

Zoho Sign helps businesses comply with the regulation in the following ways

Zoho Sign will be useful for life sciences organizations to ensure the authenticity and integrity of the records and the signatures end-to-end. It also automates the digital signature collection virtually across the globe.
  1. Security: Zoho Sign offers military-grade encryption for all records at rest and in transit using the AES-256 and TLS/SSL standards. This preserves and ensures the confidentiality, integrity, and authenticity of electronic records and electronic signatures.
  2. Audit Trails: Activity report contains the complete details about the electronic records which helps in tracking for any changes or modifications done.
  3. Validation: Zoho Sign enforces entering a one-time passcode (OTP) to access documents, and has measures to authorize signers prior to document signing. 
  4. Compliance: In the United States, Zoho Sign's administrative controls help organizations comply with  FDA's 21 CFR Part 11, which is a globally accepted regulatory standard for electronic records and electronic signatures, and also with the Electronic Signatures in Global and National Commerce (ESIGN) Act. In the EU region, Zoho Sign's controls meet the guidelines laid out in the EU Annexure 11 and complies with the eIDAS regulation (EU 910/2014).
  5. Record Retention: Zoho Sign has required control measures in place for the long-term retention and accessibility of electronic records.

Difference between 21 CFR Part 11 and EU GMP Annex 11

Though 21 CFR Part 11 and EU Annex 11 are largely similar, here are some differences.

21 CFR Part 11
EU GMP Annex 11
Electronic records and signatures for FDA-regulated activities
Computerized systems for GMP-regulated activities.
Regulatory authority
Food and Drug Administration (FDA)
Food and Drug Administration (FDA)
Companies operating under FDA regulations.
Companies operating in the European Union market and conducting GMP activities.

 Industry-standard capabilities offered by Zoho Sign in for life sciences controls module 

Preset account settings configuration - Zoho Sign enforces account level settings. Features that are not compatible with life sciences controls are disabled. Learn more

Signer validation - To access the document, the signer must enter a one-time passcode (OTP) received via email/SMS. Once the OTP has been validated, the signer has to authenticate themselves by logging into their Zoho Sign account again while adding their first signature/initial in the document. Find out more about sending and signing documents from a life sciences controls-enabled Zoho Sign account here.

Signature metadata - Along with the recipient's name, email, signing time, and signature, the reason is also collected in the visible signature. The signing reason here refers to the meaning (such as review or approval) associated with the signature. The signing time refers to the time when the signer finishes signing the document. This metadata will also be available in the electronic print version of the signed document.    

Features and reasons for their restrictions with Zoho Sign's controls for Life Sciences 

To comply with regulations related to the life sciences industry, some features available in your subscription might be restricted due to the controls enabled by your administrator.

Recipients approving the documents
  1. When a recipient signs a document sent from a Zoho Sign account with a life sciences controls-enabled Zoho Sign account, the signature and the signing reason is collected from the signer, and Zoho Sign currently does not support this in the 'Approver' role.
  2. You can alternatively achieve this same functionality by adding a signature field for your "approver" and having them add the description in the signing reason.
In-person signing
  1. For every document sent from a controls for life science controls-enabled Zoho Sign account, the responsibility in maintaining the document's integrity lies between the sender and signer.
  2. In the case of in-person signing, a third person (host) is also present at the time of signing, who may not be the responsible for the content present in the electronic record.
Re-assigning signers
  1. Only the sender must have the authority to reassign the signer of documents.
  2. If a change request needs to be done for an envelope, this needs to be approved and authorized by the sender and all other stakeholders.
Print and sign documents
  1. The signer will be re-authenticated before accessing the document sent from a controls for life sciences-enabled Zoho Sign account.
  2. This authentication cannot be done when a signer prints and signs the document.
Signing documents via Zoho Sign's mobile app (life science controls-enabled accounts cannot use their account in Zoho Sign's mobile apps)
Mobile devices do not support re-authentication of signers at the time of signing documents.
Bulk signing
For the documents to be signed in a controls for life sciences-enabled Zoho Sign account or organization, all document signers must be properly authenticated to ensure only the intended signer can access the document. In bulk signing, no authentication mode must be implemented.
When a document is sent from a controls for life sciences-enabled Zoho Sign account, the document must not be shared with anyone except the intended signer. With SignForms, the document's URL may be publicly shared and anyone with the link will be able to access the document.
Embedded signing
Documents sent from a controls for life sciences-enabled Zoho Sign account or organization must enforce an authentication method to ensure only the intended signer can access the document. In embedded signing, it is not possible to authenticate the signer.
  1. The documents or details pertaining to the documents in a controls for life sciences-enabled organization must not be shared with the unauthorized personnel or outside the organization. Document details as a result should not be shared to with third-party websites.

Controls for life sciences information in completed documents

Users can open and view the controls for life sciences information in several places, including the web application or PDF, audit trails, reports, and the certificate of completion.

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