Why SOP gaps are the most common citation
SOPs that are outdated, inconsistent, or missing from critical workflows are the first thing inspectors flag. Lean QA teams struggle to keep up with the volume and complexity of documentation requirements.
- Outdated SOPs that reflect old equipment or workflows
- Missing version history and review records
- Inconsistent format across departments
- No clear ownership or review schedule
- SOPs that don't match actual lab practice
LabComplyx SOP management approach
- Governed SOP drafting with regulatory alignment
- Structured review and version control workflows
- Human sign-off required before any SOP is finalized
- Full audit trail for creation, review, and approval
- Lifecycle tracking to flag overdue reviews