How Ovada works

How your digital Quality employee works.

Ovada is an AI agent for regulated quality operations. It reviews records against your approved SOPs and specifications, gathers the evidence, follows up on missing information, and prepares the work for qualified review, inside the systems your team already uses.

Your Quality Unit keeps final judgment and every signature.

Hire Ovada See an example workflow

Hiring starts with a walkthrough of one of your workflows.

Ovada · digital Quality employee● Available
OvadaGxP quality work · reports to your Quality Unit
Works in
OutlookTeamsSharePointYour QMS
Current assignmentLot RM-24-117 · incoming material disposition
  • 18 results checked against RM-SPEC-0142 v3
  • 1 required result missing: microbial limits
  • Supplier asked for a revised COA · 16 Sep
Every action recordedDecisions signed by your team

01 · The workflow

Watch Ovada take one lot from assignment to signed record.

Incoming material disposition, start to finish. Every workflow Ovada runs follows the same seven steps, from approved procedures to authorized, traceable work.

Someone assigns the work, the way they would a colleague.

Teams · #quality-ops9:01 AM

SOSam Ortiz @Ovada lot RM-24-117 just arrived. Can you get it ready for disposition?

OOvada On it. I’ll check the COA against RM-SPEC-0142 v3 and flag anything missing.OV-1182 · opened · recorded

It finds the procedure, the specification, and the records.

Evidence · lot RM-24-1174 sources
  • Certificate of analysissupplier email · 14 Sep
  • Approved specificationRM-SPEC-0142 v3
  • Supplier qualificationCastellan · approved
  • ProcedureSOP-QA-014 rev 8

It checks every result against the specification.

Comparison · 19 required resultsRM-SPEC-0142 v3
18 results checked1 required result missing
Identification (IR)ConformsWithin spec
Loss on drying4.2%Within spec
pH6.1Within spec
Microbial limits (TAMC/TYMC)Not reportedMissing from COA

It asks for what’s missing, and checks what comes back.

Outlook · Castellan Excipients QA16 to 18 Sep

Ovada · Your COA for lot C24117 doesn’t report microbial limits, which RM-SPEC-0142 v3 requires. Could you send a revised COA?

Castellan Excipients QA · Revised COA attached. COA_C24117_rev2.pdf

Ovada · checked the reply

✓ TAMC 120 cfu/g · TYMC <10 cfu/g. Within specification.

QA gets a review package, not a pile of documents.

Review packageRM-24-117
Microcrystalline cellulose · lot RM-24-117
19 of 19 required results within specRecommends release
Sources, each one linked
COA rev 2Spec v3Supplier approval4 messages
Ready for QA reviewOpen for review

A qualified person decides and signs. Ovada never does.

Material dispositionRM-24-117
Release, reject, or hold this lot?
Approved for releaseSigned by Dana Reyes, QA manager · 18 Sep 2026, 14:42 UTC
Meaning: approve for release21 CFR Part 11

The decision and its evidence are kept together.

Your QMS · material dispositionsSystem of record
RM-24-117 · releasedSigned 18 Sep
  • 16 Sep 09:02 · COA, spec v3, supplier approval linked
  • 16 Sep 09:03 · Gap: microbial limits missing from COA
  • 17 Sep · Follow-up sent, reply checked
  • 18 Sep · Revised COA verified, within specification
  • 18 Sep 14:42 · Part 11 e-signature · Dana Reyes
  1. 01

    AssignYou

    A request in Teams or email, an incoming record, a deadline, or a schedule starts the work.

  2. 02

    GatherOvada

    Ovada finds the approved SOP, the active specification, and the records involved.

  3. 03

    CheckOvada

    Every result is compared with the specification. Missing, conflicting, or out-of-spec data is flagged.

  4. 04

    Follow upOvada

    It asks the supplier or a colleague for what’s missing, then checks what comes back.

  5. 05

    PackageOvada

    Findings, sources, and a recommendation, assembled for review. Exceptions are labeled, never hidden.

  6. 06

    DecideQualified person

    The designated person reviews the evidence, decides, and signs with a Part 11 electronic signature.

  7. 07

    RecordSystem of record

    The decision, evidence, review history, and signature are preserved in your QMS or document system.

The controls behind each step

Each workflow is configured around your approved procedures, specifications, roles, evidence requirements, and approval paths. Explicit requirements run as deterministic checks; interpretation happens within defined boundaries; ambiguity, missing evidence, and material findings go to qualified reviewers rather than being concealed. Ovada performs only the steps authorized for that implementation.

02 · Onboarding

Onboard Ovada like a new hire.

Start with one responsibility. Before Ovada does any work, it learns your procedures, gets the access it needs, and works inside the limits you set.

  1. 01

    Choose its first responsibility

    One workflow to start, such as incoming material disposition.

  2. 02

    Share your approved procedures

    SOPs, specifications, and forms, at their current effective versions.

  3. 03

    Connect the systems it works in

    Email, Teams or Slack, your document repository, and your QMS or eQMS.

  4. 04

    Set its authority

    What it may do on its own, what it must escalate, and who signs.

  5. 05

    Review its work before it goes live

    Your team checks its output on real records, then validates the workflow per your procedures.

Training record · OvadaExample
214SOPs
466Specifications
46Quality agreements
  • SOP-QA-014Material disposition✓ Trained
  • SOP-QC-032Incoming material sampling✓ Trained
  • RM-SPEC-0142Microcrystalline cellulose✓ Trained
From document controlCurrent effective versions only

What your team provides

  • Your approved SOPs, specifications, and forms
  • A named owner for each responsibility
  • Access to the systems in scope
  • Your approval matrix: who reviews and who signs

03 · Responsibilities

Write Ovada’s job description.

Choose the quality workflows Ovada owns. Each one runs on your procedures, with a qualified person at every decision.

See all 62 skills
Job descriptionDigital Quality employee
Role
Ovada, AI quality agent
Reports to
Your Quality Unit
Works in
Email, Teams, SharePoint, your QMS
Signs
Nothing. Your team signs.

Responsibilities you can assign

  • Supplier and material quality

    Incoming material disposition

    Compares a certificate of analysis with the active specification, flags missing or out-of-specification results, and prepares a release-or-quarantine recommendation. The designated person authorizes the disposition.

  • Investigations and CAPA

    CAPA management

    Gathers evidence, follows up for missing information, and prepares corrective and preventive action plans for sign-off by the authorized quality leader.

  • Investigations and CAPA

    Deviation management

    Gathers evidence, prepares the deviation report for sign-off, and recommends whether escalation to CAPA should be considered.

  • Supplier and material quality

    Supplier quality management

    Tracks supplier certificates and expiration dates, contacts the supplier, files the updated document, and notifies the team. It handles the follow-up instead of adding another reminder.

  • Quality system operations

    Continuous quality monitoring

    Checks defined quality-system changes and controlled sources for contradictions, gaps, outdated requirements, and missing evidence.

Not responsible for: final decisions, dispositions, signatures5 of 62 skills shown

04 · Oversight

You supervise. Ovada reports in.

Ovada does the work leading up to the decision. Your quality team makes and authorizes the decision.

Ovada executes

Finds the applicable procedures and specifications, retrieves and compares the evidence, follows up on missing inputs, and prepares review-ready work linked to its sources.

Ovada escalates

Missing or conflicting evidence, out-of-specification findings, ambiguous procedures, unresolved risks, and anything outside its approved authority.

Qualified people control

Judgment, investigation conclusions, risk acceptance, review and authorization, and regulated accountability.

Ovada · active quality work5 in progress
  • Lot RM-24-117 · material dispositionReady for your decision
  • CAPA-0412 · effectiveness checkGathering evidence
  • DEV-2291 · chamber 4 excursionDrafting report
  • Castellan GMP certificate · renewalWaiting on supplier
  • SOP-QA-014 · revision impactEscalated: conflict
Assign
Teams, Slack, or email
Review
A package, every source linked
Sign
Part 11 e-signature
File
Back to your QMS

05 · Continuous quality monitoring

Between reviews, Ovada keeps watching.

Assessments show one moment. In between, SOPs change, CAPAs affect related processes, and records expire. Within your approved monitoring scope, Ovada watches for:

  • Revised SOPs or specifications
  • Contradictions between procedures and current processes
  • Unresolved quality events and CAPAs that affect related requirements
  • Expiring supplier documentation and missing evidence
  • Relevant FDA 483 observations
Explore continuous quality monitoring
SOP change detectedSOP-QA-014 · rev 8

Retain reserve samples for 12 24 months. Record the reviewer’s initials e-signature.

What the change touches
4 procedures2 training records1 quality agreement
Each owner gets the evidenceRouted to owners

06 · Systems and validation

Works inside your systems and controls.

Ovada is a headless AI quality agent. In plain terms: it has no new app for your team to live in. Work is assigned and reviewed in the tools you already use, and your QMS or eQMS stays the system of record.

  1. Your peopleReview the work, resolve exceptions, authorize the outcome
  2. OvadaRetrieves information, performs permitted steps, prepares evidence-backed work, escalates judgment calls
  3. Your systemsQMS or eQMS, document repository, shared drives, email, project tools
Systems store quality informationOvada performs quality work
QMS or eQMS
Stores records and routes processes. Ovada does the work across the systems involved.
Workflow automation
Moves structured inputs. Ovada interprets documents, finds gaps, and escalates.
Copilots and general AI
Answer questions. Ovada executes permitted steps within your procedures and approval paths.
21 CFR Part 111Dietary supplement manufacturers →Specifications, identity testing, batch records, and quality control review.21 CFR Part 211Pharmaceutical CDMOs and sponsors →Component testing, investigations, record review, and quality unit authority.
21 CFR Part 11 and validationValidation package included

Ovada is 21 CFR Part 11 compliant: electronic records, electronic signatures, audit trails, and access controls are addressed in its validated system. The package includes IQ/OQ/PQ documentation, user and functional requirements specifications, a traceability matrix, and supporting validation evidence.

Questions before you hire Ovada.

01

What does onboarding involve?

You choose a first responsibility, share the approved SOPs and specifications behind it, connect the systems it needs, and set what Ovada may do on its own and what it must escalate. Your team reviews its work on real records before it goes live, then validates the workflow under your procedures.

02

Where does my team assign and review Ovada’s work?

In the tools you already use. Your team assigns work in Teams, Slack, or email, reviews a package with every source linked, and signs with a 21 CFR Part 11 electronic signature. Approved records return to your QMS or document system.

03

Which systems does Ovada work with?

Ovada works across the systems a quality team already uses: email, Microsoft Teams or Slack, document repositories and shared drives such as SharePoint, and your QMS or eQMS. The systems connected for each workflow are set during onboarding, and your QMS stays the system of record.

04

Is Ovada quality management software?

Ovada provides the capabilities companies look for in quality management software, but through a different operating model. Instead of requiring your team to work inside another standalone QMS, Ovada acts as a headless AI quality agent across your existing QMS, eQMS, documents, email, and approved business systems. It executes regulated quality workflows, gathers evidence, identifies exceptions, and prepares decisions for qualified review and authorization. For 21 CFR Part 11 purposes, applicable software requirements still apply, and Ovada includes controls for electronic signatures, audit trails, validation, and repeatable workflow evidence.

Read more: Is Ovada quality management software?

05

Does Ovada replace our QMS or eQMS?

No. Your QMS, eQMS, document repository, or other approved platform remains the system of record. Ovada works across connected and authorized systems to perform tasks, gather evidence, apply approved procedures, identify exceptions, and prepare work for review.

Read more: Does an AI quality agent replace your QMS?

06

Does Ovada make final quality decisions?

Ovada performs the work leading up to the decision. It gathers evidence, executes controlled workflow steps, identifies exceptions, and prepares recommendations. Qualified people retain final judgment, authorization, and regulated accountability.

Read more: Can AI make final quality decisions?

07

How is Ovada different from ChatGPT, Claude, or another general-purpose AI tool?

General-purpose AI provides broad intelligence. Ovada adds your approved procedures, current specifications, evidence requirements, workflow controls, system access, authority boundaries, and human approval paths so AI can execute defined quality work within your operating environment.

Read more: AI quality agent vs ChatGPT or Claude

08

How does Ovada decide what can be automated?

Each workflow is implemented within an approved scope. Explicit checks can use deterministic rules where appropriate. Model intelligence can support work requiring contextual interpretation. Missing evidence, conflicting requirements, uncertainty, and matters requiring judgment are escalated to qualified people.

Read more: What quality work can be automated with AI?

09

What happens when Ovada identifies a problem?

Ovada surfaces the issue with the available source evidence and relevant operating context, then routes it to the appropriate qualified person. The exact escalation path depends on the implemented workflow, permissions, and approval structure.

Read more: What happens when AI finds a problem

10

Can Ovada monitor the quality system continuously?

Yes. Ovada can continuously monitor approved sources for defined changes, discrepancies, deadlines, missing evidence, expiring records, and relevant regulatory observations. When it identifies a potential issue, it gathers the supporting context and routes the finding to the appropriate person.

Read more: Continuous quality monitoring

11

Does Ovada support electronic signatures and audit trails?

Yes. Ovada supports 21 CFR Part 11 electronic signatures and maintains audit trails for regulated workflows. These capabilities are addressed through Ovada’s validated system and supporting validation package, which includes IQ/OQ/PQ documentation, requirements specifications, and traceability documentation.

Read more: Electronic signatures and audit trails for AI workflows

Put your digital Quality employee to work.

Bring one repetitive, evidence-heavy quality workflow. We’ll walk through how Ovada would handle it, from assignment to signed record.

Hire Ovada See the example workflow again

Hiring starts with a walkthrough of one of your workflows.

Want to see it on your own records first? Apply for the free 30-day pilot, starting November 2026.