Executive Summary
Regulatory compliance in Salesforce is not optional for FDA-regulated businesses. Native Salesforce tools fail to meet 21 CFR Part 11 requirements for audit trails, data provenance, and eSignatures.
In this whitepaper, we outline the critical audit trail gaps in native Salesforce tracking and show how to close them without costly reconfiguration or revalidation.
You’ll learn:
- The audit trail requirements under FDA 21 CFR Part 11 and what they mean for Salesforce users
- The limitations of native Salesforce history tracking in meeting compliance needs
- How to maintain data integrity and traceability across all fields, objects, and automations
- Practical steps to achieve audit readiness without slowing operations or adding admin burden
Built for Regulated Salesforce Environments
- SOC 2 Type 2 Certified for security and process controls
- Salesforce Security Review Approved for safe deployment
- Trusted by leading life sciences companies to protect their audit readiness
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Next Steps
Ready to see how these recommendations apply to your Salesforce org?
Book a 15-Minute Audit Readiness Review- Your current audit trail coverage in Salesforce
- The biggest compliance gaps to address now
- How to prepare for an FDA inspection without revalidating existing workflows
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