AUTOMATED.
TRACEABLE.
DEFENSIBLE.
MANUAL.
FRAGMENTED.
EXPOSED.
Every action timestamped, user-attributed, and immutable. FDA 21 CFR Part 11 compliant out of the box.
Spreadsheet edits overwrite history. Version control is whoever saved last. Auditors find gaps.
Automated escalation at 72h. Owner accountability tracked. Closure requires documented evidence.
Email chains lose context. No escalation logic. Findings sit open past recertification windows.
One-click response generation pulls all linked evidence, SOPs, and corrective actions automatically.
Legal, QA, and ops scramble to reconstruct a paper trail that may have gaps or contradictions.
Includes platform fee, prep time, and external auditor hours. Customers average 87% cost reduction.
Internal labor, external consultant fees, rework, and potential citation penalties compound fast.
SPC control charts trigger instant alerts when a batch drifts from spec. Linked to SOP version.
Operators log on paper. Supervisors review at shift change. By then, 400 units are already suspect.
All facilities, all certifications, all open findings in one view. Drill down in two clicks.
Every plant has its own format. Consolidation is a monthly manual exercise that's always stale.
Continuous compliance monitoring means no prep sprint. Last 3 years of evidence accessible instantly.
ISO recertification triggers a company-wide fire drill. Binders assembled. Gaps discovered late.
Automated reminders, manager escalation, and evidence requirements drive closure before deadlines.
Without system enforcement, 42% of findings carry over into the next audit cycle.
THE MATH DOESN'T LIE.
Every row above is a number you can verify. Run yours.
THREE ROLES.
THREE CRISES.
ONE PLATFORM.
Real scenarios from real facilities. The names are different. The spreadsheet hell is identical.
ISO 9001 RECERTIFICATION IN 72 HOURS
SCENARIO: Your registrar calls Monday. Audit is Thursday.
Without Comply: 6 weeks of prep compressed into 72 hours. You're pulling binders from 3 facilities, reconciling spreadsheet versions, and praying no one deleted the email chain from 2023.
With Comply: Three years of audit evidence accessible in two clicks. Every CAPA linked to its finding. Every SOP version-controlled with approval signatures. Your registrar has seen this before — they move fast.
OSHA CITATION ACROSS 4 FACILITIES
SCENARIO: A citation at Plant 2 may implicate Plants 1, 3, and 4.
Without Comply: You're emailing four facility managers, waiting on different spreadsheet formats, and manually cross-referencing OSHA 300 logs that don't talk to each other.
With Comply: One dashboard. All four facilities. Filter by citation type, facility, or open status. The abatement plan generates automatically with the relevant SOP and responsible owner pre-populated.
BATCH FAILURE AT 2:00 AM
SCENARIO: You're woken up. Batch 44-C failed final QC.
Without Comply: You have no idea which SOP version was active, who signed the deviation, or whether this batch is the first or the fifth. You're calling people at 2 AM to piece together a story.
With Comply: Push notification includes batch ID, linked SOP version, deviation record, and the last five similar events. You approve the hold, initiate CAPA, and notify the customer — all from your phone.
We had our ISO 9001 surveillance audit 11 days after go-live. The auditor spent 40 minutes on our CAPA records — normally that's where we lose points. We got zero findings. First time in six years.
RUN YOUR
COMPLIANCE SCORE.
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