AI SOP Generator
Standard Operating Procedures must be clear, actionable, and aligned with regulatory requirements. Vespper helps you draft, update, and maintain SOPs with version control and traceability to the processes and requirements they document.
1. Quality Management Standards
SOPs are the primary mechanism for translating quality management system requirements into actionable workplace procedures.
ISO 9001:2015 Clause 7.5
- Documented information requirements for process procedures and work instructions
- Document creation, updating, and control procedures
- Retention and disposition requirements for quality records
GMP / GDP Requirements
- Good Manufacturing Practice documentation requirements under 21 CFR Part 211 (FDA)
- Good Documentation Practice principles: attributable, legible, contemporaneous, original, accurate (ALCOA)
- Process validation documentation and continued process verification
- ISO 9001 certification auditors verify that SOPs exist for all QMS-required processes
- GMP deficiencies in SOP documentation are among the most cited FDA warning letter observations
2. Industry-Specific SOP Requirements
Regulated industries impose specific requirements on SOP content, format, and electronic management.
FDA 21 CFR Part 11
- Electronic records and electronic signatures requirements for SOP management systems
- Audit trail requirements for electronic SOP creation, modification, and approval
- System validation requirements for electronic document management systems
OSHA & EPA Requirements
- Process safety management documentation requirements under 29 CFR 1910.119
- Environmental compliance procedure documentation for EPA reporting
- Hazard communication and safety data sheet accessibility procedures
- 21 CFR Part 11 non-compliance can invalidate all electronically managed SOPs
- OSHA citations for inadequate safety procedures carry per-violation penalties up to $156,259
3. SOP Structure & Format
Well-structured SOPs reduce ambiguity and ensure consistent execution across personnel and shifts.
Procedure Documentation Standards
- Standard sections: purpose, scope, responsibilities, definitions, procedure steps, references, revision history
- Step-by-step instruction clarity with decision points and exception handling
- Cross-references to work instructions, forms, and supporting documents
- Ambiguous procedure steps are the leading cause of process deviations in regulated environments
- Missing decision points force operators to make undocumented judgment calls
4. Training & Change Management
SOPs must be linked to training requirements and managed through a controlled change process.
Training and Competency
- Training record requirements per ISO 9001 Clause 7.2 — competence, training, and awareness
- Read-and-understand documentation for SOP changes affecting trained personnel
- Competency assessment and retraining trigger criteria
Change Control
- Document change request (DCR) workflow with impact assessment
- Periodic review and revalidation requirements with defined review cycles
- Regulatory change impact assessment triggering SOP updates
- SOPs modified without retraining affected personnel create compliance gaps discoverable in audit
- Missing periodic review evidence is a top-10 audit finding across ISO and GMP frameworks
What happens when documentation falls short
- Regulatory citations from outdated or missing SOPs during facility inspections
- Quality system failures from undocumented processes leading to product defects
- Workplace safety incidents from unclear or ambiguous procedure instructions
- FDA warning letters from GMP documentation deficiencies
- ISO certification loss from inadequate document control
What this means for your team
How Vespper helps with SOPs
Process-to-procedure traceability
Upload process descriptions, work instructions, and regulatory requirements. Vespper generates SOPs that trace each step to its source.
Consistent SOP templates
Generate SOPs with consistent structure: purpose, scope, responsibilities, procedure steps, references, and revision history.
Version-controlled updates
When processes change, update your SOPs with AI and maintain a complete revision history showing what changed and why.
Regulatory alignment
Ensure your SOPs address the specific requirements of ISO 9001, GMP, FDA 21 CFR Part 11, or other applicable standards.
Generate your SOPs in 3 steps
Upload process information
Connect process maps, work instructions, regulatory requirements, and existing SOPs that need updating.
Generate structured SOPs
Vespper drafts SOPs with consistent formatting, clear procedure steps, and traceability to source requirements.
Review, approve, and distribute
Review procedure steps, verify regulatory alignment, approve the SOP, and maintain your document control records.
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