A fixed-scope review of your GxP data integrity posture — audit trails, electronic records, access controls and ALCOA++ — ending in a board-ready gap report and a prioritized remediation plan. Find the exposure before an inspector does.
Why it matters
Data integrity is still the most-cited area in FDA enforcement
Missing or unreviewed audit trails, shared logins, uncontrolled spreadsheets and unverifiable records remain the fastest route to a 483 or warning letter. Expectations are tightening on both sides of the Atlantic — the EU’s draft Annex 11 revision expands from five pages to nineteen and mandates quality risk management across the full system lifecycle.
Scope
What the assessment covers
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ALCOA++ across systems
Attributable, Legible, Contemporaneous, Original, Accurate — plus Complete, Consistent, Enduring, Available — evaluated for your critical GxP records.
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Audit-trail review
Are audit trails enabled, configured, protected and actually reviewed? We assess design and the review practice behind it.
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Access & identity controls
Unique accounts, role segregation, no shared logins, e-signature integrity under 21 CFR Part 11 and Annex 11.
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Spreadsheets & hybrid records
Uncontrolled Excel, paper-to-electronic transcription and hybrid workflows — the classic blind spots.
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Backup, archive & retention
Records enduring and available for their full retention period, restorable and readable.
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Governance & SOPs
Data-integrity policy, training and the procedures that keep controls in place over time.
Deliverables
What you receive
- System-by-system data-integrity gap analysis
- Findings rated by patient/product risk and inspection exposure
- ALCOA++ scorecard across your in-scope systems
- Prioritized, sequenced remediation roadmap
- Quick wins vs. structural fixes, with effort estimates
- Board-ready summary you can take upstairs
Fixed-fee, transparent scope
A defined assessment with a defined price and timeline — no open-ended hourly billing. Scope scales to the number of systems in review. Remediation is delivered as a separate, scoped engagement on your priorities.
Get a scoped quoteHow it works
From exposure to a plan in weeks, not quarters
STEP 01
Scope
Agree the systems, records and timeframe in review.
STEP 02
Assess
Document review, system walkthroughs and control testing.
STEP 03
Report
Risk-rated findings and a board-ready gap report.
STEP 04
Remediate
Prioritized fixes, delivered as a scoped follow-on.
Why SQA Solution
Defensible findings, delivered by senior practitioners
Inspection-grade rigor
We assess to the standard an FDA or EMA investigator would apply — clear evidence, traceable conclusions.
Risk-based prioritization
You get a sequenced plan that fixes the highest-exposure gaps first, not an undifferentiated list.
Current on Part 11 & Annex 11
Including the draft Annex 11 revision and its expanded lifecycle QRM expectations.
Fixed-fee entry
A low-risk way to start: a defined assessment that scopes the work before any larger commitment.
Free self-check
Where does your data integrity stand?
A two-minute readiness check across audit trails, access control and ALCOA++. Instant result, no sales call.
Know your data-integrity exposure before your next inspection
Tell us which systems are in scope. We’ll come back with a fixed-fee assessment plan and timeline.
Request a Quote
