NetSuite can support life sciences companies working to meet 21 CFR Part 11 requirements through the right system configuration, electronic signature controls, and validation processes.
Part 11 sets requirements for electronic records and signatures used in FDA-regulated activities. NetSuite provides tools for managing user access, tracking record changes, and running approval workflows. With additional electronic signature capabilities where needed, companies can build processes that support their regulatory and operational needs.
Here’s how these capabilities work together and what to consider when setting up NetSuite for regulated activities.
What Does 21 CFR Part 11 Require?
Part 11 explains when electronic records and signatures can be used in place of paper records and handwritten signatures. For life sciences companies, this may include certain quality records, manufacturing records, and approvals covered by applicable FDA regulations.
Several key requirements guide how these records should be managed:
- Audit trails: Record relevant actions and changes, including who made them and when.
- User access: Give authorized users access to the records and actions appropriate to their roles.
- Electronic signature details: Show the signer's name, the date and time of signing, and the meaning of the signature, such as approval or review.
- Signature protection: Keep each electronic signature linked to the record it belongs to.
- Signer identity: Meet applicable identity verification requirements. Non-biometric electronic signatures generally use two distinct identification components, such as an ID code and password.
- Validation: Maintain documented evidence that the system performs as intended for its regulated use.
Together, these controls help companies maintain trustworthy records and demonstrate how regulated decisions are made.
How NetSuite Supports Part 11 Requirements
NetSuite offers several capabilities that help companies manage access, records, and approvals.
Roles and permissions let administrators control which records users can access and which actions they can perform. Well-designed roles help align system access with each person's responsibilities.
System notes and transaction history help teams review changes made to records. During implementation, teams can assess their audit trail needs and configure appropriate controls for each regulated process.
Approval workflows help route records to designated people for review and approval. These workflows can be configured around business processes, with electronic signature controls added where the applicable requirements call for them.
Security settings help protect user accounts and support controlled access. Companies can establish account security policies that align with their procedures and regulatory needs.
For workflows that require specific electronic signature details, additional capabilities can capture the signer's identity, signature meaning, and timestamp as part of the approval process.
Adding Electronic Signature Controls in NetSuite
Archer Insights' 21 CFR Part 11 module is designed to work with NetSuite approval workflows. The module can require users to re-enter their NetSuite credentials when signing, capture the reason for signing, and record the signer's name, timestamp, and action. It also provides a printable signature record and captures approval, rejection, and routing history.
These features help companies manage electronic signatures within their NetSuite environment and keep approval information connected to the relevant business records.
The module can be configured for selected approval types, including supported standard and custom records. During implementation, teams can define which processes need electronic signatures and test the signature workflow, user permissions, record links, and audit history.
This approach helps align the system with the company's documented procedures and the requirements of its regulated activities.
Validation and Company Procedures
A strong Part 11 program brings together system controls, documented procedures, and evidence that the system works as intended.
Key activities include:
- Define requirements: Identify the regulated records and workflows, then document what each process needs to do.
- Test important functions: Verify approval steps, electronic signatures, access controls, audit trails, and record retrieval.
- Document procedures: Explain how users sign records, protect their credentials, and manage rejected or corrected records.
- Review access: Confirm that authorized users have the appropriate permissions for their responsibilities.
- Manage system changes: Assess updates and configuration changes to determine whether additional testing is needed.
Archer Insights CSA and CSV help life sciences companies assess requirements, test configured workflows, and document results. Testing can be planned according to the system's intended use and the risks associated with product quality, patient safety, and record integrity. This gives teams a structured way to demonstrate that their NetSuite configuration supports the processes they rely on.
For companies managing quality processes, Quality Management System can also support workflows involving deviations, corrective and preventive actions (CAPA), and change control.
By bringing ERP configuration, electronic signatures, and validation support together, Archer Insights helps life sciences companies build processes that are easier to manage, review, and document.
FAQs
Can NetSuite support 21 CFR Part 11 requirements?
Yes. NetSuite provides capabilities for user access, record history, and approval workflows. With appropriate configuration, electronic signature controls, procedures, and validation, companies can use it to support their Part 11 requirements.
Which NetSuite workflows may need electronic signatures?
Depending on the applicable regulations and intended use, these may include certain quality approvals, manufacturing records, batch release processes, and other regulated decisions. An assessment helps define which workflows require additional controls.
How does an electronic signature module support validation?
An electronic signature module provides technical controls that can be tested and documented as part of the company's validation approach. Testing should reflect the intended use and applicable requirements.
Can companies use an external electronic signature tool?
Yes, depending on the workflow and system design. Companies can assess whether an external solution or a NetSuite-based module best supports their recordkeeping, integration, and validation needs.
What is the first step toward supporting Part 11 requirements?
Start by identifying the electronic records and approval processes covered by applicable FDA requirements. From there, define the necessary controls, review the current configuration, and develop a plan for testing and documentation.