For quality teams under 21 CFR Parts 111 and 211
Every quality decision, evidence-ready.
Your AI teammate assembles the evidence and drafts the work behind every quality decision. Your team reviews and signs each one.
The agent does the work. Your team signs the decisions.
Your systems remain the systems of record. Your qualified team remains the decision-maker.
Built for 21 CFR Part 11 · 21 CFR Part 111 · 21 CFR Part 211 · GAMP 5 · EU Annex 11
Ovada · Quality operations teammate
Ovada is working · Detect
- 01Detect
- 02Work
- 03Hand off
01 / Detected
Monitoring layerControlled document approved
SOP-QA-014 v8 changed.
The monitoring layer detected downstream training and procedure impact.
No prompt requiredOvada started the impact review.
Works across Email · Slack · Teams · Project toolsControlled review in Ovada
01 / The problem
Your quality team is buried in work an AI teammate should handle.
Evidence gathering. Investigation follow-up. Change coordination. Training checks. Your team spends its day chasing records and moving work forward, leaving less time for the decisions that require their judgment.
02 / The platform
An agentic monitoring layer that never stops. AI skills you activate on top.
Ovada continuously monitors your quality system against a signed quality baseline. Add pre-validated AI skills as your needs grow. A qualified person activates each with an electronic signature, without revalidating the platform.
CAPA coordination
Change-impact assessment
Inspection preparation
Monitoring layer · always on
Signed quality baselineEvidence mapAudit trail
03 / How it works
Ovada does the work. You sign the decision.
Each AI skill carries work from evidence to decision. Every comparison, recommendation, approval, and change stays linked in an append-only audit trail.
Quality · Magnesium stearate, NF · Lot MG-26-0412
Agent · comparing COA to active specification
COA-2026-0671Controlled quality record
1 flagIncoming COA vs specification
ParameterSpecCOAStatus
IdentificationConformsConformsPass
Loss on drying≤ 6.0%4.1%Pass
Residue on ignition≤ 10.0%8.2%Pass
Assay≥ 98.0%96.1%Fail
Audit trail · append-only
14:02:11 coa.received · COA-2026-0671
14:02:14 coa.parsed · 4 parameters · cited
04 / Onboarding and monitoring
Build the quality baseline. Monitor every change.
Ovada maps your SOPs to regulations, related procedures, roles, and training, then surfaces any gaps before your team signs the quality baseline. From then on, it checks every change against that signed quality baseline and routes new findings to the right owner.
01 / Onboarding
Map your workflows. Sign the quality baseline.
What Ovada mapsOnboarding
SOPs+Regulations+Roles+Training
Maps relationships and checks alignment
Gap found during onboarding
Release authority conflicts across two procedures.
Review finding → Sign quality baseline
02 / Always on
Monitor every change.
What Ovada monitorsSigned quality baseline active
SOP revisions+Training records+Deviations and CAPAs+Change controls
Checks each change against the signed quality baseline
Finding routed to owner
Training gap after SOP revision.
Owner reviews → Signs disposition
05 / Security and validation
Built for the validated environment.
Every Ovada output links to its source. Qualified people sign regulated decisions, and every action is preserved in an append-only audit trail. Ovada supports GAMP 5 risk-based validation and aligns with Part 11 and EU Annex 11.
01Every decision cites its source
02Qualified people sign
03Audit trail cannot be edited
04Inspection-ready by default
06 / For consulting and validation partners
Give clients a living system, not a report that starts aging on delivery.
Certified partners use Ovada to assess the client's full quality system, surface any gaps, and establish the signed quality baseline. Ovada then monitors every change, so the work continues beyond a static report.
Partner with OvadaThe AI validation toolkit GAMP 5 and Part 11 guidance for quality leaders evaluating AI: validation scoping, vendor audit questions, and audit-trail requirements. Coming soon.
07 / FAQ
Questions quality teams ask.
Clear boundaries for regulated work, validation, implementation, and human authority.
01What does Ovada work from?+
Ovada works from the quality records your team already uses, including COAs, SOPs, batch records, specifications, email, paper records, and third-party laboratory workflows. It operates across your full production stack in your existing formats, with every extracted fact linked to its source.
02Who signs the decisions?+
A qualified person on your team signs every regulated decision. Every statement is cited to its source, confidence thresholds route uncertainty, and deterministic rules govern regulatory logic. The agent never signs. Ever.
03What does the signed quality baseline include?+
Onboarding maps your SOPs against the regulations that govern you, including cross-SOP contradictions. A qualified reviewer signs the quality baseline, and the agent and monitoring operate against it from day one.
04What does activating a skill involve?+
Skills ship pre-validated with their citation sets. A qualified person activates each with a Part 11 signature, extending what the agent does without reopening platform validation.
05Does continuous monitoring create inspection risk if findings pile up?+
No finding sits unacknowledged. Your team signs a disposition for every finding: remediate, accept with rationale, or dispute. The record shows continuous self-identification with documented follow-through.
06Do you replace our consultants?+
No. Certified partners deliver gap assessments and SOP-mapping on Ovada. If you work with a consultancy you trust, they can deliver on the platform.
See Ovada at work
Put Ovada to work for your quality team.
Bring a workflow. In 20 minutes, see what Ovada can monitor, complete, and hand back ready for review.
Book a demo