Gap Assessment Report
Every finding with its severity, the applicable regulation text, the supporting excerpt or explicit evidence gap, and a remediation priority.
GMP Gap Assessment
Find the Gaps in Your Quality System Before They Become Findings
Ovada checks your Standard Operating Procedures (SOPs) and records against every applicable requirement in your Part, shows the evidence behind each call, and hands your quality unit a Findings Package to review and act on.
SOP-QC-012 · Rev 4Effective 02 Jun 2026
Incoming component testing
5 · Receipt and testing5.1 Receiving, sampling, and testing of components follow this procedure.
5.2 Components may be released on the supplier’s certificate of analysis.
5.3 QC reviews and approves each component lot before use.
21 CFR 111.153Supported
21 CFR 111.75(a)(1)Partial · identity test
21 CFR 111.103Supported
21 CFR 111.503Absent · no procedure
PDFGap Assessment ReportFindings by severity · cited to your SOPs
XLSXTraceability MatrixRequirement · SOP · section · excerpt
Findings Package · ready for QA review
- To the Findings Package
- 5 business days
- Agreed before document intake
- Fixed price
- Applicable to your Part, assessed
- Every requirement
- Consultant review included
- 60 minutes
The deliverable
What every GMP gap assessment finding shows
A pass/fail score tells you nothing you can act on. Every finding shows the work behind the call, from the requirement to the SOP passage, so your team can check the evidence rather than take it on faith.
Finding 07 · MajorSample
Identity testing of dietary ingredients
- 1Requirement
- 21 CFR 111.75(a)(1): at least one identity test for each dietary ingredient
- 2Document
- SOP-QC-012 Incoming Component Testing · Rev 4 · §5.2
- 3Evidence
- “Components may be released on the supplier’s certificate of analysis.”
- 4Coverage
- Partial · CoA reliance is allowed for dietary ingredients
5
Quality dispositionRemediate · Accept · Dispute
- The exact requirement assessed, quoted from the regulation.
- The procedure meant to cover it, with its version and section.
- The passage the determination relied on, or an explicit gap.
- Coverage stated as supported, partial, or absent, with severity set in advance.
- A qualified reviewer decides what happens next.
Traceability Matrix
Every applicable documentary requirement mapped to your document, its section and the supporting excerpt, or marked partial or absent.
60-Minute Consultant Review
A regulatory consultant walks the highest-risk findings with your quality unit and sets the remediation sequence.
Not another AI-generated compliance report
You could paste your SOPs into ChatGPT and get a plausible answer. Run it again tomorrow and you’ll get a different one. The FDA expects a defined, repeatable process, so Ovada runs every GMP gap analysis inside a fixed framework.
| What matters | Pasting SOPs into a chatbot | A consultant’s review | Ovada’s gap assessment |
|---|---|---|---|
| Method | Invented on each run | Depends on the reviewer | Fixed before any document is read |
| Repeatability | The same SOPs can pass today and fail tomorrow | Varies from one reviewer to the next | Same documents, same requirements, same result |
| Coverage | Whatever fits in the prompt | Scoped to the hours in the engagement | Every applicable documentary requirement in your Part |
| Evidence | Plausible prose, nothing to trace | Findings summarized in prose | Requirement, SOP, section, and excerpt, or an explicit gap |
| Turnaround | Minutes, but not defensible | Often four to eight weeks | Five business days |
From your SOPs to a Findings Package in five business days
The method is fixed before any document is read, so the result can’t bend toward a preferred answer. See how Ovada works.
- Day 0
Scope and intake
A 20-minute call sets the Part and the SOPs, policies, and records in scope. The price is agreed before intake.
- Days 1 to 5
Requirement-level analysis
Ovada maps every applicable requirement to the SOP passages meant to address it. Ovada’s regulatory team verifies each finding.
- Day 5
Findings Package delivered
The Gap Assessment Report and the Traceability Matrix, with findings ranked by severity.
- After delivery
Consultant review
Sixty minutes with a regulatory consultant to agree what to fix first.
Two ways to get it
Buy the assessment on its own, or get it as the first step of working with Ovada. The assessment is the same either way.
A fixed-scope assessment
One assessment, no subscription required. Use it before an inspection, a customer audit, or a move into a new regulatory scope.
The first step of onboarding
Every Ovada deployment starts here. Once your quality unit has reviewed the findings, they become the baseline that continuous monitoring keeps current as SOPs, records, and regulations change.
Explore continuous quality monitoringWhat the assessment covers, and what it doesn’t
Every report states its scope at the top. No vague “compliant” score, just the coverage behind the assessment and where you still need to look.
Included in the assessment
- ✓SOPs, documented controls, and required records
- ✓Requirement-to-document traceability
- ✓Missing, partial, or conflicting coverage
- ✓Severity and remediation priorities
Requires an on-site assessment
- −Employee practices and interviews
- −Executed-record testing
- −Facility and equipment conditions
- −Operational effectiveness and data integrity in practice
A gap assessment is not an inspection, and passing one is not proof of compliance. It shows you where you stand and where to look next.
Your team decides every finding
Each finding becomes a tracked item your quality unit owns. It stays open until a qualified reviewer signs one of three dispositions, and it doesn’t disappear because you ran a new assessment.
- 01 / Remediate
Fix the procedure or record. The finding stays open until the change is reviewed.
- 02 / Accept
Accept the gap with a documented rationale, through the right quality authority.
- 03 / Dispute
Challenge the determination. The reviewer’s decision is kept with the finding.
Questions about the gap assessment
01How long does a GMP gap assessment take?
+
The Findings Package arrives within five business days of document intake. The 60-minute consultant review is scheduled after delivery.
02What do we need to provide?
+
Your SOPs, policies, forms, and record templates for the Part in scope. A 20-minute scoping call confirms the list before intake.
03How is this different from asking ChatGPT to review our SOPs?
+
A chatbot invents its method on each run, so the same SOPs can pass one day and fail the next. Ovada runs a fixed framework set before any document is read, and every finding traces to the requirement, the SOP section, and the passage it relied on.
04Is a gap assessment an inspection or a certification?
+
No. It evaluates documentary coverage of written-procedure and records requirements. It does not assess practice on the floor and is not a certification of compliance with any regulation.
05Can we buy the assessment without using Ovada day to day?
+
Yes. It is one fixed-scope assessment with no subscription required, at a price agreed before document intake.
06What happens after the assessment?
+
Your quality unit dispositions each finding. If you go on to use Ovada, the reviewed findings become the baseline that continuous quality monitoring keeps current.
Know where the gaps are. Know what to do next.
Give your quality unit a structured view of where the quality system stands today, with the evidence behind every finding.