E-Signatures That Stand Up in Audits

Electronic signatures only count when you can prove who signed, when, and why.

Shared accounts, weak identity proofing, and incomplete signature manifests leave

you exposed. Inspectors know exactly where to probe, and a single weak control

can unravel confidence in your entire quality system.

This playbook locks down attribution. You will tighten identity proofing,

enforce unique credentials, capture reason-for-sign, and monitor exceptions so

every approval withstands auditor scrutiny.

Why bulletproof e-signatures matter

• Regulatory compliance: Part 11 and Annex 11 expect that electronic

signatures are legally binding equivalents to hand-written signatures.

• Process integrity: Approvals drive batch release, change control, deviations,

and clinical decisions. When identity is suspect, downstream decisions are too.

• Cybersecurity: Strong authentication protects against unauthorized actions

and insider misuse.

• Culture of accountability: Unique credentials reinforce that individuals own

their decisions.

Step 1: Strengthen identity proofing

• Validate identity at onboarding using government ID, HR confirmation, and, when

required, background checks. Record the verification evidence in a controlled

system.

• For remote or contract staff, use secure video verification or third-party

identity services. Document the method used.

• Require re-verification during role changes, long absences, or access to

higher-risk systems.

• Maintain an auditable log linking each credential to the verified individual.

Step 2: Enforce unique credentials and robust authentication

• Eliminate shared logins. Every person must have a unique user ID tied to their

identity proofing record.

• Implement multifactor authentication (MFA) for high-risk transactions or

systems. Document MFA algorithms, reset procedures, and exception handling.

• Automate provisioning and deprovisioning flows by integrating HR systems with

identity management. Accounts should activate only after training and deactivate

immediately upon exit or role change.

• Monitor for dormant accounts. Disable access after defined inactivity periods

and require revalidation to reactivate.

Step 3: Capture the intent behind every signature

• Configure systems to store the meaning of the signature (approve, review,

submit, verify) alongside the record ID and timestamp.

• Require justification comments when signatures deviate from standard workflows

(e.g., emergency approvals).

• Ensure signature manifestation appears on printouts: name, date/time, and

meaning. Inspectors look for this proof of compliance.

• Periodically sample signatures to confirm the recorded reason matches the

underlying action or decision.

Step 4: Control the signature process end to end

• Sequence signatures to match SOPs (e.g., preparer before approver). Block out-

of-order signing unless predefined emergency paths exist.

• Implement session timeouts and inactivity locks so users cannot leave a session

open for others to exploit.

• Log failed authentication attempts and unusual signing patterns. Investigate and

document outcomes.

• Train users on signature expectations, emphasizing legal equivalence and

personal accountability.

Step 5: Monitor and audit continuously

• Run quarterly access reviews comparing HR rosters to active accounts.

• Track provisioning and deprovisioning turnaround time. Slow revocation is a red

flag.

• Report on MFA adoption, password reset frequency, and exceptions to highlight

system health.

• Include e-signature checks in internal audits and supplier assessments.

• Maintain dashboards for leadership showing zero shared accounts, timely

revocations, and sampled signature accuracy.

Metrics that prove control

• Time from employee exit to account revocation.

• Number of shared or generic accounts detected (target zero).

• Percentage of signatures with complete manifestation (name, timestamp, meaning).

• Exception rate from signature sampling (aim for <1 percent).

• MFA enrollment and usage rates.

45-day roadmap

1. Days 1-10: Audit existing accounts across validated systems. Identify

shared logins, orphaned accounts, and missing MFA.

2. Days 11-20: Update identity proofing SOPs with HR and IT, including

re-verification triggers. Communicate expectations to managers.

3. Days 21-30: Configure systems to enforce unique credentials, implement or

tighten MFA, and enable reason-for-sign capture. Test with a pilot group.

4. Days 31-45: Launch signature sampling, monitor revocation times, and report

metrics to quality governance.

Frequently asked questions

• Are shared logins ever acceptable? No. If a system cannot support unique

IDs, restrict its use for GxP activities or implement compensating controls and

a plan to migrate.

• How fast should revocation occur? Within hours of notification. Document

the SLA and measure compliance.

• Do we need handwritten signature equivalents? Maintain an attestation that

electronic signatures are legally binding, signed by leadership, and include it

in the validation package.

• What about contractors and partners? Require the same proofing and unique

credentials. If using sponsor accounts, manage them under your SOPs.

Sustain the win

Schedule quarterly access reviews, rotate identity proofing approvers, and weave

signature expectations into onboarding and refresher training. Recognize teams

that maintain zero shared-account findings. With disciplined controls, electronic

signatures become a strength—not a risk—during audits.