Problems we solve
Teams under audit pressure often inherit gaps: outdated SOPs, unclear ownership, systems that grew faster than validation. We help close those gaps with practical documentation and remediation that fits how you work.
- GxP documentation gaps before inspections or partner audits
- IQ/OQ/PQ and validation packages for lab and manufacturing systems
- 21 CFR Part 11 and electronic records alignment
- IT change management and audit trail design
- SOX-aligned controls where finance and IT intersect
- Data integrity and access control reviews
Deliverables
- Standard operating procedures (SOPs) and work instructions
- Risk assessments and remediation plans
- Validation protocols and summary reports
- Change control templates and approval workflows
- Audit support: evidence packs, interview prep, finding response
- Training materials for sustained compliance
Our approach
Assess
Map systems, gaps, and regulatory drivers against your current state.
Remediate
Build documentation, fix controls, and validate where required.
Sustain
Transfer ownership with SOPs and rhythms your team can maintain.
Industries we support
We support life sciences, biotech, regulated R&D, and any organization that needs audit trails, validation, and documentation discipline.
Who this is for
Good fit
- Organizations preparing for audits, inspections, or partner reviews
- Teams that need SOPs, validation, and change control that stick
- IT and QA groups that need a shared language for documentation
Not the right fit
- One-off document formatting with no system context
- Organizations unwilling to assign internal owners