Compliance with regulatory standards is key when it comes to the life sciences industry, as it ensures protected confidential data and industry-wide integrity. Patient records, pharmaceutical parameters, medical research documents—this is just a glimpse into the volumes of sensitive data that life sciences industries deal with on a regular basis. Collecting and managing physically signed documents with such data opens up life sciences companies to an array of risks like the mishandling of confidential information and reputational damage.
To safeguard and regulate the collection, use, and maintenance of such vulnerable electronic records, regional and international bodies have laid down guidelines such as the Food and Drug Administration's Code of Federal Regulations Title 21 Part 11 (FDA CFR 21 Part 11) and EU EudraLex's Good Manufacturing Practices - Annex 11 (EU GMP Annex 11). Lack of compliance with these regulations may result in:
- Penalties
Warning letters
Delays in applying for and manufacturing new drugs
Seizure of drugs and devices
Highest level of compliance with Zoho Sign
Compliance with the innumerable standards set by these frameworks can be a herculean task without the right set of tools. Zoho Sign now offers controls for life sciences that you can enable with a single click. With this feature, you can stay compliant with 21 CFR Part 11 and EU GMP Annex 11.
The numerous benefits of this module include:
Secure data storage, transit, and management
Easy compliance and validation
Risk mitigation
Cost-effective documentation
Automated signing processes
Popular use cases
Patient consent forms
Manufacturing and sales reports
Hiring and onboarding documents
Research documents
Procurement forms
Non-disclosure agreements
Certificates
Compliance documents
What is 21 CFR Part 11?
It is a set of federal regulations to be followed by industries that are under the auspices of the FDA, such as the life sciences industry. Part 11 under Title 21 defines what electronic records and electronic signatures are, and also specifies the standards by which electronic signatures can be deemed equivalent to physical signatures. This section further talks about the creation, modification, storage, transmission, use, archival, maintenance, and retrieval of electronic records and the systems in which they are kept or used.
21 CFR Part 11's compliance criteria summarized
The FDA's CFR Title 21 governs all policies in regard to food and drugs in the USA. Part 11 particularly explains how electronic records and electronic signatures must be created, shared, maintained, retrieved, or submitted in life science industries.
Part 11 has three subparts:
Subpart A - General Provisions: This section covers the scope, implementation, and definitions of the terms used.
Subpart B - Electronic Records: In this subpart, detailed explanations of controls for open and closed systems, signature manifestations, and signature or record linking are provided.
Subpart C - Electronic Signatures: This section explains the general requirements, components, and controls for identification codes or passwords to be set in place for electronic signatures.
Enabling Zoho Sign's controls for life sciences makes the platform a closed system, allowing you stay CFR-compliant. You can read more on 21 CFR Part 11 standards here. Learn how Zoho Sign helps you comply with the criteria here.
What is EU GMP Annex 11?
EudraLex's Volume 4 covers the good manufacturing practices that human and veterinary medical product manufacturers may adopt. Annex 11 describes how computerized systems must be implemented, used, and maintained to ensure data security.
As per the definitions of EU GMP Annex 11, a computerized system is considered equivalent to its manual counterpart if it does not:
Tamper with the quality of the product
Reduce the levels of process controls
Lower the standards of quality assured
Escalate chances of risks in the process
Zoho Sign qualifies these criteria and is categorized as a computerized system to help your organization comply with EU GMP Annex 11.
EU GMP Annex 11's compliance criteria summarized
GMP Annex 11 is divided into three sections: General, Project Phase, and Operational Phase.
General: The document starts with detailed guidelines on risk management and mitigation, personnel management and training, and the necessary verification and documentation to be undertaken when third-party suppliers or service providers are involved are enlisted under this section.
Project Phase: This section provides elaborate validation protocols for computerized systems, including documentation standards, traceability, and appropriate test parameters.
Operational Phase: The final section presents a framework on the transmission, security, storage, accuracy, archival, and traceability of data is given under this section. Also, further guidelines on electronic signatures, incident management, and periodic evaluations can be found here.
Stay compliant using Zoho Sign
With Zoho Sign's controls for life sciences, you can ensure that your digital signatures and signed documents are compliant with international life sciences regulations. This feature provides you with:
Visible signatures with metadata
ID verification of signers
Security, control, and validation
Customized legal disclosures
Free onboarding and training sessions, amongst other controls
To enable this feature, reach out to us at support@zohosign.com (non-EU) and support@eu.zohosign.com (EU). Use Zoho Sign to stay compliant without compromise!
Resources:Help guide| Help video | Feature page
Have any queries or feedback? Write to us via the support emails aforementioned, or connect with us through the comments section below. Happy Zoho Signing!
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