GMP Gap Assessment
Find the Gaps in Your Quality System Before They Become Findings
Ovada checks your registered Standard Operating Procedures (SOPs) against the regulations that apply to you, flags where coverage falls short, and hands your Quality Unit a structured findings ledger to review and act on.
- Traceable findings
- Fixed framework
- Quality review on every finding
- Scope stated up front
01 / Gap Assessment
A GMP Gap Assessment Should Tell You More Than What’s Missing
A pass/fail score tells you nothing you can act on. A useful GMP gap assessment shows the work behind every call.
What Every Finding Should Show
Finding record
6 items- 01The requirement it assessed✓
- 02The SOP or controlled document meant to cover it✓
- 03The passage the determination relied on✓
- 04Where coverage is incomplete✓
- 05How serious the gap is✓
- 06What a person needs to review✓
Findings You Can Trace, Not an Opinion You Trust
Ovada keeps the full requirement-to-document mapping and the exact passages it relied on. You see the evidence behind every call, so your team can check it rather than take it on faith.
02 / Gap Assessment
From Your SOPs to an Actionable Gap Assessment
Four steps, with no method invented on the day:
- 01Register your documentation.
Ovada starts with the controlled SOPs, policies, and forms in scope.
- 02Map requirements to procedures.
Match each applicable requirement to the documents and passages meant to address it. The method is fixed before any document is read, so the result can’t bend toward a preferred answer.
- 03Surface and rank the gaps.
Requirements that aren’t fully covered become findings. Each carries a criticality set in advance, not assigned after the result is known.
- 04Hand findings to Quality.
Your team reviews each finding against the cited passage and document version, then decides what to do.
03 / Gap Assessment
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. That’s the problem.
Why Generic AI Can’t Give You a Repeatable Result
Generic AI is nondeterministic. It invents its method on the fly, so the same SOPs can pass one day and fail the next. The Food and Drug Administration (FDA) expects a defined, repeatable process. A tool that improvises can’t give you one.
What a Fixed Framework Adds
Ovada runs every GMP gap analysis inside a controlled framework:
Controlled framework
7 items- 01A defined scope✓
- 02A consistent requirement library✓
- 03Controlled assessment logic✓
- 04Requirement-to-document traceability✓
- 05Criticality set before the result is known✓
- 06Version-specific findings✓
- 07Human Quality review on every finding✓
04 / Gap Assessment
See Exactly What Was Assessed, and What Wasn’t
Most tools hand you a verdict. Ovada shows you the boundary around it: what it looked at, what it found, and what it deliberately left out.
Scope, Stated Up Front
Ovada records what it assessed and what it left out. Every report states the scope at the top, lists findings by criticality, and spells out what wasn’t covered. No vague “compliant” score, just the coverage behind the assessment: what was evaluated, what was found, and where you still need to look.
Not an Inspection, and Not Proof of Compliance
A gap assessment is not an inspection, and passing one is not proof of compliance. Ovada reads your registered documents. It does not observe your floor or certify your system. It shows you where you stand and where to look next.
05 / Gap Assessment
Turn Findings Into Work
A finding is only useful if someone acts on it. Ovada turns each gap into a tracked item that your Quality Unit owns, reviews, and signs off on.
A Finding Stays Open Until It’s Handled
A report gets filed and forgotten. Ovada keeps findings in a ledger built for Quality to work through. A finding stays open until someone dispositions it. It doesn’t disappear because you ran a new assessment.
What Your Team Decides for Each Finding
For each finding, a qualified reviewer signs one of three dispositions:
Remediate it.
Accept it, with a documented rationale, through the right Quality authority.
Dispute it.
06 / Gap Assessment
Your Starting Point for Continuous Monitoring
A gap assessment is a snapshot. Your quality system keeps changing after it. New SOPs, deviations, CAPAs, and change controls can quietly reopen a gap you thought was closed.
Ovada flags the documents each finding relied on. When one of them changes, the requirements that depended on it come back for another look. Your first assessment becomes an always-on control instead of a report that ages on the shelf.
07 / Gap Assessment
Know Where the Gaps Are. Know What to Do Next.
Give your Quality Unit a faster, structured way to see where the quality system stands today, check the evidence behind every finding, and put attention where it’s needed most.