Internal GxP audits and FDA inspection readiness
Internal QMS audits and mock inspections across Change Control, Deviation, CAPA, Audit Management, Document Control and Training.
What we audit
Change Control, Deviation, CAPA, Audit Management, Document Control and Training.
Data integrity and computer system controls
Who can change records, audit trails, unique logins, backups and validation status, checked system by system.
Mock inspections
A multi area mock inspection with storyboards and a remediation roadmap.
After a 483: findings and CAPA follow up
Help scoping the response, planning CAPA and checking that actions are effective.
Prices
| Package | Scope and deliverables | Timeline | Flat price |
|---|---|---|---|
| Internal QMS Audit | One process area (for example, CAPA or document control), report and CAPA plan | 2 weeks | $4,500 |
| Mock Inspection / Readiness | Multi area mock inspection, storyboards, remediation roadmap | 3 to 4 weeks | $12,000 |
Each package lists what is out of scope. Anything beyond bills at the rate card or converts to a change order at a pre stated price.
FAQ
- What does FDA look at first in data integrity?
- Who can change records, audit trails, unique logins, backups and whether systems are validated. We check each of these system by system.
- What is a mock inspection?
- A simulated regulatory inspection of your quality system, with inspection style questions, document requests and a debrief.
- Can you help after a 483 or warning letter?
- Yes. We help scope the response, plan CAPA and check that actions are effective.
- How long does an internal audit take?
- It depends on scope. Packages and timelines are listed on the pricing page.