Quality risk management, CAPA, and audit readiness
Risk assessments with practical mitigations, developed with your QA and site leadership, plus gap analyses, SOP authoring, CAPA support, and Lean Six Sigma process improvement.
Risk assessments people can use
ICH Q9 asks that the effort and formality of risk management match the level of risk. We facilitate FMEAs and other risk assessments with the people who know the process, and write them so the mitigations are specific, owned, and traceable into your validation and change control decisions.
The same risk basis then justifies where you qualify, how much you test, and how often you review.
Getting ready for an inspection
A pre-inspection gap assessment reviews your procedures, records, and validation packages against the requirements that apply to your site, and ranks what to fix first. The most-cited drug GMP observations are procedures that are not written or not followed, which makes documentation the place to start.
When something has already gone wrong, we support root cause analysis, CAPA plans, and effectiveness checks that hold up to review.
What we deliver
- Risk assessments (FMEA, ICH Q9)
- GMP and pre-inspection gap assessments
- CAPA plans and effectiveness checks
- Root cause analysis and investigation reports
- Change control assessments
- Periodic reviews
- Lean Six Sigma process improvement
Regulations and standards
- ICH Q9
- ICH Q10
- 21 CFR Part 210 and 211
- ISO 22716
Common questions
What does a GMP gap assessment include?
A review of your procedures, records, validation status, and facility practices against the regulations and standards that apply to your site, with a prioritized list of findings and recommended actions.
How long does a company have to respond to an FDA Form 483?
FDA expects a written response within 15 business days. A strong response addresses each observation with root cause, corrective and preventive actions, and realistic timelines.
When is an FMEA the right tool?
FMEA suits processes and equipment where failure modes can be listed and scored for severity, occurrence, and detection. Simpler decisions may only need a documented risk ranking, and ICH Q9 supports scaling the formality to the risk.
Tell us about your project
Whether it's a single qualification or an audit on the calendar, send a few details and we'll reply within one business day.