Build and Ongoing Support
Ongoing Advisory and Continuous Readiness
Readiness decays. Procedures drift, people change roles, and evidence that was solid at the last audit goes stale. Ongoing advisory keeps an advisor and your audit readiness workspace working between audits, so your system stays ready whenever the next one comes.
What You Receive
- 01Periodic Re-Assessment Reports
- 02Live Action Plan
- 03Internal Audit Reports
- 04Management Review Input Package
- 05Annual Mock Inspection Closeout
Every finding is reviewed and approved by a qualified QMS advisor before it reaches you.
What It Is
Many firms prepare hard for a scheduled audit and then let the system coast. The trouble is that FDA usually gives only about five days' notice of a routine inspection and none for a for-cause one, notified bodies run unannounced audits, and under the QMSR an investigator can read your internal audit and management review records. A system that's ready only in the weeks before a planned audit is exposed for most of the year.
Continuous readiness means the action plan stays live after the first assessment's findings close. We re-assess on an agreed cadence, review the evidence your team submits, conduct or support internal audits, help prepare management review inputs and watch for regulatory and standards changes that affect your system. Each relevant change becomes a finding or an action with an owner, not a memo nobody tracks.
Each year we run a mock inspection with the FDA Inspection Simulator: an advisor plays the investigator, document requests run on response clocks, and interviews are scored for answer discipline. Practice observations convert into findings in the same action plan, so the exercise ends with work assigned. Engagements are scoped after an assessment call.
When You Need It
- You closed out an assessment or a Form 483 response and want the fixes to stay fixed
- Your quality team is small and has no one to review evidence or audit independently
- You hold ISO 13485 or MDSAP certification and want surveillance audits to feel routine
- It's been a while since your last FDA inspection and you can't predict when the next one comes
- Regulatory and standards changes keep arriving and nobody owns assessing their impact
- Management review happens, but its inputs are assembled the night before
What We Do
- 01
Keep the Action Plan Live
Open findings stay assigned, with owners, due dates and evidence requirements. New issues from complaints, audits or changes enter the same plan.
- 02
Re-Assess Periodically
On an agreed cadence, the AI runs a fresh first pass over changed documents and an advisor reviews the results, so drift is caught early.
- 03
Review Evidence as It Arrives
Your team submits evidence as work completes, and an advisor accepts it or requests a revision with a note.
- 04
Support Internal Audit and Management Review
We conduct internal audits or audit alongside your team, and help assemble management review inputs and record the decisions and actions that follow.
- 05
Monitor Regulatory Change
We follow changes in FDA requirements, the standards you rely on and the markets you sell into, and turn the relevant ones into findings with owners.
- 06
Run a Yearly Mock Inspection
An advisor-led practice inspection in the FDA Inspection Simulator, scoped by CP 7382.850 areas, with practice observations converted into findings.
Deliverables
Periodic Re-Assessment Reports
What changed since the last review, new findings and the status of open ones.
Live Action Plan
Every open finding with owner, due date, severity and evidence requirements, current at any point in the year.
Internal Audit Reports
Reports for the audits we conduct, written factually and linked to corrections or CAPA.
Management Review Input Package
Audit results, CAPA status, complaint and supplier trends and open findings, assembled ahead of each review.
Annual Mock Inspection Closeout
Practice observations, interview feedback and a simulated NAI, VAI or OAI outcome, clearly marked as a practice exercise.
How the Platform Helps
One Workspace for the Whole Year
Documents, findings, evidence, CAPA records and comments stay in one audit readiness workspace, with notifications when something needs your attention.
Immutable Activity History
Every submission, review and decision is recorded, so you can show how a finding was handled months later.
Form 483 and Warning Letter Tracker
If an inspection does produce a Form 483, the tracker counts down the 15 business days and the draft response composer starts from your existing findings and CAPA records.
Mock Inspections That Feed the Plan
Practice observations from the FDA Inspection Simulator convert into findings, so each year's exercise leaves the system stronger.
Audits and Inspections It Prepares You For
Mock Audit and Mock Inspection
A realistic practice inspection, with an advisor playing the FDA investigator, before the real one arrives.
Internal Audit
Audits your own team runs of your quality system, now open to FDA inspection under the QMSR.
ISO 13485 Surveillance Audit
The periodic audits, at least annually, that support continued ISO 13485 certification between renewals.
FDA Non-Baseline Surveillance Inspection
A focused FDA surveillance inspection that goes deep on selected QMS areas under Compliance Program 7382.850.
EU Notified Body Audit (Including Unannounced Audits)
Conformity assessment, surveillance and unannounced audits by an EU notified body under the MDR or IVDR.
Standards and Regulations in Scope
Questions About This Service
How often do you re-assess?
The cadence is agreed when the engagement is scoped, based on the size of your system, how fast it's changing and your audit calendar. Re-assessments focus on changed documents and open risk areas rather than repeating the full first assessment.
Does the mock inspection predict how FDA would classify an inspection?
No. The simulated NAI, VAI or OAI outcome is a practice result. It shows where your system and your people would be exposed, but FDA's classification depends on what its investigators actually find.
Can you act as our internal auditor?
Yes. Our advisors can conduct internal audits, which also solves independence for small teams. Reports are written factually, since under the QMSR internal audit records are open to FDA inspection.
What happens if we receive a Form 483 during the engagement?
The response moves to the front of the plan. FDA asks firms to respond in writing within 15 business days after the inspection closes for the response to be considered, and the platform's tracker counts that down while we help you draft and support the response.
How are ongoing engagements priced?
Engagements are scoped after an assessment call. By then we understand your system, your audit calendar and how much support your team needs, so the scope fits the work.
Request an Assessment
Discuss Ongoing Advisory and Continuous Readiness With an Advisor
Tell us about your devices, your documents and your timeline, and an advisor will scope the work with you. Please don't send confidential documents yet: secure upload is set up after onboarding.
