Training & Consultancy
Compliance Consultancy
When an audit is coming, you need people who have prepared for one before. We help your QA and engineering teams close gaps, strengthen documentation and walk into inspections prepared.
What's included
Scope of service
Validation support
Process, cleaning, HVAC and computer system validation.
SOPs & technical documents
Preparation and review of SOPs, work instructions and technical documents.
Risk assessment & change control
Risk assessments, change control and impact analysis.
Deviation & CAPA
Investigation, root cause analysis, and CAPA planning and implementation.
Audit readiness
Mock audits, gap analysis and support during the audit.
What you receive
- Gap assessment report
- Prioritised action plan
- Prepared or revised documents
How we work
Four steps, fully documented.
- 1
Understand the requirement
Site visit or call to map your instruments, equipment, URS and audit timelines.
- 2
Plan & execute
Approved protocols, calibrated master standards and trained engineers on site.
- 3
Deliver results & reports
Signed certificates, raw data and validation reports in your QA format.
- 4
Ensure compliance
Due-date tracking, re-qualification planning and support during audits.
Do you support regulatory audit preparation?+
We run mock audits and gap assessments against applicable GMP expectations, then help your teams close the observations before the actual inspection.
Related
Other services
Let's plan your compliance consultancy.
Tell us what you need. We'll come back with a plan, a timeline and a clear quote, usually within one working day.