1. Clinical trials
2. Manufacturing
3. Sales and Marketing
4. Legal and compliance
5. Procurement
6. HR and onboarding

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

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

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

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

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.
   

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.
   

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.
   

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.
   

Mobile devices do not support re-authentication of signers at the time of signing documents.

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.

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