Shared Logins
One username for the whole shift, or the admin password on a sticky note. Attributability — knowing who did what — is gone, and with it the foundation of every record the system holds.
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Service · Data Integrity & 21 CFR Part 11
Records you can defend, byte by byte.
Every release decision, every investigation, every inspection stands on records — and records stand on trust. Shared logins, unreviewed audit trails, and paper printouts standing in for electronic originals quietly hollow out that trust. We assess data integrity across your operation against ALCOA+ principles and build the Part 11 controls that make records defensible again.
WHY NOW
What “trustworthy records” actually means.
ALCOA+ is the expectation. Part 11 is the mechanism. Most plants are missing both in the same places.
ALCOA+Attributable, Legible, Contemporaneous, Original, Accurate — plus Complete, Consistent, Enduring, and Available. Every record, every system, every time.
Audit TrailsPart 11 requires secure, computer-generated, time-stamped audit trails — and, critically, that they are reviewed. Enabled-but-never-reviewed is the most common gap we find.
Hybrid SystemsPaper printouts of electronic records are still the original-record problem in most small plants: the printout is reviewed while the electronic original — the one Part 11 governs — is ignored.
WHERE IT BREAKS
The four data-integrity failures we see most.
Rarely malicious. Usually the result of systems outgrowing their controls.
Audit Trails Nobody Reviews
The system logs everything and nobody reads it. Result changes, deleted runs, and reprocessed data sit in the trail unnoticed until an inspector goes looking.
Paper Standing In for Electronic Originals
Operators print the record, sign the paper, and file it — while the electronic data it came from is uncontrolled, unbacked-up, and unreviewed. The “record” isn't the record.
Uncontrolled Spreadsheets and USB Drives
Critical calculations and data transfers happen on files outside every control: no versioning, no access restriction, no backup. The quality system has a hole shaped exactly like a thumb drive.
OUR METHOD
Assess, remediate, sustain.
We find the gaps honestly, fix them in risk order, and leave controls your team can actually operate.
Data-Integrity Assessment
A structured review of records, systems, and practices against ALCOA+ — interviews, record sampling, and system walkthroughs that surface how data really moves.
Remediation Planning
Findings ranked by risk to product quality and inspection exposure, sequenced into a plan your team can execute — quick containment first, systemic fixes next.
Control Implementation
Unique logins, role-based access, audit-trail review SOPs, backup and recovery verification, and spreadsheet controls — implemented, not just recommended.
Ongoing Monitoring
Periodic data-integrity review routines, trending of audit-trail exceptions, and training that sticks — so the fixes survive the first busy month.
WHERE IT APPLIES
One method, five industries.
Cannabis is our home base — the method was built there first. The same evidence discipline serves each industry below, mapped to its own regulations.
Food & Beverage
Preventive controls, supplier verification, environmental monitoring, and traceability under 21 CFR Part 117 and FSMA.
Dietary Supplements
Component qualification, master manufacturing records, and laboratory controls under 21 CFR Part 111.
Cosmetics
Safety substantiation, GMP records, and adverse-event readiness under MoCRA.
Pet Food
Preventive controls for animal food, supplier programs, and sanitation under 21 CFR Part 507.
QUESTIONS
Data integrity, answered.
What does an assessment actually look at?
How records are created, modified, reviewed, stored, and retrieved — across paper, hybrid, and fully electronic systems. We sample real records, watch real workflows, and test whether the controls on paper match practice.
We're mostly paper-based. Does data integrity still apply?
Yes. ALCOA+ applies to paper too — and paper has its own classic gaps: backdating, blank fields filled later, uncontrolled forms, and second-person review that never happened. We assess both.
How disruptive is remediation?
Less than a 483. We sequence by risk: containment of the worst gaps first, then systemic controls phased around production. Most plants keep running normally throughout.
Can you help us respond to data-integrity observations?
Yes. Data-integrity 483 observations get dedicated attention because they undermine every other record. We investigate scope, remediate controls, and build the evidence the response commits to.
Do you validate the systems as part of this?
Where needed, yes — data-integrity remediation and CSV go together. Our computer system validation program covers the validation lifecycle; this program covers the record-trust layer across all systems.
FREE TOOL
Start with the free assessment.
Answer 27 questions about audit trails, access control, ALCOA+, and review practice, and get a scored data integrity gap report on the spot — the same framework our experts use, mapped to FDA guidance and recent warning-letter patterns.
Don't let the first gap be found under pressure.
Start with a free call about your records — where the trust is thinnest, and what an inspector would find first. We'll name your top 3 GMP risks and give you an honest fit assessment. No pressure, no pitch.