Paper 40: FDA Part 11 Compliance & Self-Certification
How Solace Browser's SHA-256 hash chain, approval gates, and sealed evidence bundles satisfy 21 CFR Part 11 electronic records requirements. Includes SOPs and self-certification template.
What Part 11 requires
21 CFR Part 11 governs electronic records in FDA-regulated environments. It requires that records be attributable, contemporaneous, original, accurate, and that signatures be linked to the signer in a tamper-evident way.
Most software satisfies Part 11 through expensive dedicated systems. Solace satisfies it through architecture: SHA-256 hash chains, OAuth3-scoped signatures, and fail-closed approval gates built into the base product.
The Solace compliance architecture
Every Solace Browser run produces a sealed evidence bundle: a manifest, action log, screenshots (optional), and a SHA-256 hash chain linking each record to its predecessor. Tampering with any record breaks the chain.
Signatures use OAuth3 tokens with specific scope, TTL, and user binding. The result satisfies ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available.
- SHA-256 hash chain on every evidence bundle
- OAuth3-scoped e-signatures with TTL
- Approval gate required before any irreversible action
- Sealed bundle with public verification endpoint
- Part 11 Architected storage on Pro and above
Self-certification
Solace provides a self-certification template that maps each Part 11 requirement to the specific Solace feature that satisfies it. Teams in regulated industries can use this to demonstrate compliance to auditors.
At $188 per month, Solace Enterprise is 85 percent cheaper than the cheapest dedicated Part 11 vendor — and the evidence quality is higher because it uses hash chains rather than timestamps.