Why FDA Documentation Is Different
FDA-regulated industries operate under a different standard than most. A 483 observation isn't just an inconvenience — it can shut down production, delay product launches, or trigger consent decrees that cost millions. The quality system regulation (21 CFR Part 820) requires documented procedures for virtually every aspect of device manufacturing, from design controls to complaint handling.
The challenge is volume and specificity. A mid-size medical device company might maintain 200+ SOPs across design, manufacturing, quality, and regulatory affairs. Each one needs to reference the correct CFR sections, follow a consistent format that auditors expect, and stay current as regulations evolve.
Part 11 adds another layer: any procedure involving electronic records needs to address audit trails, access controls, and electronic signatures. Most companies discover Part 11 gaps during FDA inspections, not before.
Important
Procedurio generates SOP drafts as a starting point. All FDA-regulated procedures must be reviewed by qualified personnel, validated against your specific quality system, and approved through your document control process before use.
FDA Regulations Procedurio Maps To
Select FDA 21 CFR Part 820 or Part 11 in the wizard, and Procedurio references the relevant sections while generating your SOP structure.
Design Controls
SOPs for design planning, input/output, review, verification, validation, and design transfer.
Nonconforming Product (CAPA)
Corrective and preventive action procedures — investigating causes, implementing fixes, verifying effectiveness.
Complaint Handling
Procedures for receiving, reviewing, and investigating customer complaints. MDR reporting triggers.
Process Validation
SOPs for IQ/OQ/PQ validation of manufacturing processes where results cannot be fully verified by inspection.
Electronic Records & Signatures
Procedures for electronic record integrity, audit trails, access controls, and electronic signature use.
Device History Record (DHR)
Procedures for compiling the complete production history of each device batch, including acceptance records.
How It Works for FDA-Regulated Companies
1. Select FDA Framework
Choose Pharmaceutical, Medical Device, or Biotech as your industry. Select 21 CFR Part 820, Part 11, or both. The AI loads the relevant regulatory requirements.
2. Describe the Procedure
Tell Maya what your SOP covers — CAPA, design review, complaint handling, process validation. She asks clarifying questions to get the scope right.
3. Review & Export
Get a structured draft with CFR references, appropriate sections for your QMS, and professional formatting. Export to Word for your document control system.
Manual SOP Writing vs Procedurio
| Feature | Manual Approach | Procedurio |
|---|---|---|
| Time to create an SOP | 6–12 hours | 20–45 minutes |
| FDA regulation mapping | Manual CFR cross-reference | Automatic — Part 820/Part 11 clauses embedded |
| CAPA procedure structure | Build from scratch or templates | Pre-structured with investigation, root cause, verification steps |
| Consistency across QMS | Varies by author and department | Uniform structure, terminology, and formatting |
| Audit trail awareness | Often missed in first draft | Part 11 controls referenced where applicable |
| Professional export | Manual Word formatting | One-click Word export with metadata |