21 CFR Part 11 defines the FDA's expectations for electronic records and electronic signatures. Compliance is not a one-time checkbox — it is an operating posture spanning validation, access control, audit trails and data retention.
Proclin's systems enforce unique user credentials, role-based access, tamper-evident audit trails and time-stamped e-signatures. We validate systems against documented user requirements and maintain traceability from specification to test.
For sponsors, the practical takeaway is to demand evidence: validation summaries, audit-trail samples and SOPs governing change control. Combined with GDPR-aligned data protection, this foundation protects both patients and program timelines.
Written by Compliance Team
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