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Password-verified signatures
Approvers enter NetSuite credentials fresh at every signing event
FDA-regulated life sciencesNative NetSuite
21 CFR Part 11 Electronic Signatures
Electronic signatures for NetSuite
Enable secure electronic signatures, tamper-evident audit trails, and inspection-ready records directly within your NetSuite environment.
Compliance controls
- Password-verified signatures at every signing event
- Tamper-evident audit trail per record
- Printable PDF signature record per approval
- Timestamp and stated reason captured on signing
Full
Tamper-evident audit trail
User identity, timestamp, action, reason, rejections, and re-routing captured per record
Printable signature records
Human-readable signature record available for inspection or physical review
Auto
Timestamp and stated reason
Date, time, signer, and signature meaning captured automatically at signing
Overview
Part 11 signature controls built into NetSuite approvals
The Archer 21 CFR Part 11 Electronic Signature Module layers onto NetSuite's existing approval workflow. It can be enabled or disabled per approval type, applies to standard and custom record types, and avoids adding a separate e-signature system to your validated environment.
Each signing event requires the designated approver to authenticate with their NetSuite credentials, provide the stated reason for signing, and complete the action inside the same environment as the underlying record. The signer, printed name, timestamp, action, and signature meaning are captured automatically.
The result is a computer-generated audit trail and printable signature record for approvals, transactions, and custom records, including Quality Management System records.
What the module does
Signature controls built directly into NetSuite approvals
Authentication
Signature authentication
Each signing event requires the approver to enter their existing NetSuite login credentials at the time of signing. Credentials are not cached between events.
- Signer user ID, printed name, and timestamp captured automatically
- Only the designated recipient can complete the signing event
- Signatures cannot be delegated or bypassed
Electronic records
Inspection-ready signature records
A signature record is generated for each approval event and retained in NetSuite for regulatory inspection or internal audit.
- Signed document key fields displayed with all signatories
- Stated reason and timestamp captured for every signature
- Printable PDF output available for physical audit review
Audit trail
Tamper-evident approval history
Every approval step is logged with identity, timestamp, action taken, rejection decisions, and re-routing events.
- Computer-generated trail available on every record
- Rejections and re-routes captured alongside approvals
- Designed for closed-system audit trail expectations
Workflow scope
Configurable record coverage
E-signatures are toggled at the approval type level, so quality and operations teams can apply Part 11 controls where the regulatory context requires them.
- Available on standard approval records and transaction types
- Supports custom records including QMS records
- Maintains segregation of duties in approval workflows
Key features
Technical controls for Part 11 environments
Each feature maps to a technical control requirement under 21 CFR Part 11 Subparts B and C.
21 CFR 11.200(a)
Password-verified electronic signatures
Credentials are entered fresh at every signing event with no session reuse, supporting the identification component requirement for non-biometric signatures.
21 CFR 11.50(a)(3)
Stated reason for signing
Approvers enter the meaning associated with each signature at the time of signing.
21 CFR 11.10(e)
Computer-generated audit trail
Date and time of entries and actions are captured automatically for closed-system audit trail requirements.
Approval control
Configurable approval routing
E-signatures can be enabled or disabled per approval type, with routing controlled at the record type level.
21 CFR 11.50(a)
Printable PDF signature record
Signature records include printed name, date and time of signing, and meaning of the signature.
21 CFR 11.300
Password complexity and expiration
Password rules are enforced by the NetSuite environment and configured to align with organizational security policies.
Record scope
Universal record coverage
Available on standard approval records, transaction types, and custom records, including Quality Management System records.
Workflow history
Reject and re-route history
Rejection decisions and re-routing events are captured in the audit trail alongside approval actions.
How it works
From initiation to inspection-ready record in 7 steps
Each step captures the data elements required by 21 CFR Part 11 without manual handoff or a separate system.
- 01
Initiate approval
The record enters the configured approval workflow and routes to the designated approver.
- 02
Authenticate signer
The approver enters login credentials at the time of signing. Identity is verified against the NetSuite user record.
- 03
Capture reason
The approver enters the stated reason for signing, satisfying the signature manifestation requirement.
- 04
Record timestamp
Date and time are captured automatically at the moment of signing. The timestamp is system-generated and not user-editable.
- 05
Generate audit trail
A full audit entry is created with user ID, action, timestamp, and reason, then retained on the record.
- 06
Produce signature record
An e-signature record is generated showing the signed document, key fields, all signatories, and timestamps.
- 07
Retain documentation
A printable PDF is available and the complete record remains accessible within NetSuite for inspection.
Who it is for
Built for FDA-regulated NetSuite teams
Life sciences and healthcare teams that need compliant approvals without paper routing or a disconnected signature tool.
Biotech and Pharma
GxP approvals and quality records
Teams managing regulated workflows need signature controls and audit trails directly on the records supporting development, manufacturing, and release.
CDMO
Multi-client approval documentation
Manufacturing organizations need consistent signature records across client-specific workflows, quality records, and operational transactions.
Medical Device
QMSR and quality system records
Device companies need approval evidence, signer identity, and record retention across quality system and operational records.
Quality and Regulatory
Inspection-ready record retrieval
Quality teams can access signature history, audit trail, rejections, re-routes, and PDF records without pre-audit data assembly.
Finance and SOX
Segregation of duties
Approval routing and non-delegable signatures help maintain authority structures required in SOX and GxP environments.
NetSuite administrators
Configurable approval scope
Administrators can enable Part 11 controls on the approval types that require them without adding a separate platform.
FAQ
21 CFR Part 11 and electronic signatures in NetSuite
What is 21 CFR Part 11?
21 CFR Part 11 is the FDA regulation that establishes when electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures. It applies to records created, modified, maintained, archived, retrieved, or transmitted under FDA regulations.
What makes an electronic signature Part 11 compliant?
A compliant non-biometric electronic signature must be unique to one individual, use distinct identification components such as an ID code and password, display the printed name of the signer, include the date and time of signing, include the meaning associated with the signature, and remain linked to the associated electronic record.
Does NetSuite support Part 11 compliance?
NetSuite is a configurable cloud ERP platform. Its native functionality does not automatically constitute 21 CFR Part 11 compliance. Compliance depends on configuration, procedural controls, validated software layers, Computer Software Assurance activities, SOPs, access governance, and the system's intended use.
Are electronic signatures legally equivalent to handwritten signatures?
Under 21 CFR 11.1(b), electronic signatures that meet Part 11 requirements are considered equivalent to traditional handwritten signatures for records required to be maintained under FDA regulations. The equivalence depends on meeting applicable technical and procedural requirements.
What documentation is required for Part 11 compliance?
Organizations typically maintain SOPs for electronic signature use, CSA or validation documentation showing the system performs as intended, audit trail records, records of personnel authorized to use the system, and signature records showing printed name, date and time, and stated meaning.
How are audit trails maintained in the Archer module?
The module captures every approval step with user identity, timestamp, action taken, rejection events, and re-routing history. The audit trail is computer-generated and accessible on every record without prior notice or data extraction.
Can electronic signatures be used on custom NetSuite records?
Yes. The module is available on standard approval records, NetSuite transaction types, and custom records, including Quality Management System records. It can be enabled or disabled independently per approval type.
How does Archer validate Part 11 controls?
Archer applies Computer Software Assurance methodology to requirements documentation, configuration verification, and testing of critical functions including signature capture, audit trail integrity, access control behavior, and record retention. View CSA and CSV services.
Ready to implement Part 11 e-signatures in NetSuite?
Start with a Part 11 readiness assessment
Archer's team works exclusively with FDA-regulated organizations. We will scope signature controls, CSA needs, approval workflows, and deployment path for your NetSuite environment.