Pharmaceutical Equipment FMEA Software, GMP

15.3% less unplanned downtimeone critical fill-finish station

32% → 73% work order completenesscustomer scoring method

20,000 failure reports and 100+ manuals56 hidden attributes surfaced in 4 weeks

How it works, every week

Your equipment risk assessments keep themselves current.

New evidence, matched

Deviations, CAPAs and work orders checked against your equipment FMEAs as they arrive.

One short list a week

Your engineer and QA get a short list, not a re-review.

Approve once, it reaches everything

Each approved change reaches every comparable filler, isolator and lyophilizer.

Nothing changes without your engineer's approval. Every change versioned and sourced.

From evidence to action

Turn evidence into approved action.

Protect production

Fillers, isolators and lyophilizers ranked by criticality, every failure mode sourced.

Connect CAPAs

Deviations and CAPAs checked against the risk analysis. Gaps flagged with root cause.

Control revisions

Accepted changes enter change control. Rejected ones never touch the record.

Reuse approved work

Approved content reaches comparable equipment. Each team confirms it applies.

Fit validated systems

Validated systems stay untouched. Your VPC or on-premise, with IQ/OQ/PQ support.

Improve maintenance data

Work order quality scored, so weak documentation never hides a risk.

Customer evidence

What changed in one fill-finish engagement.

Scoped fill-finish engagement 15.3% less unplanned downtime on one critical station Seven equipment gaps found. Work order completeness from 32% to 73%.

From our clients

What pharma reliability teams are saying.

“From 20,000 failure reports and 100+ manuals, Tacit AI surfaced 56 data quality and failure attributes we had no visibility into. First actionable results came within 4 weeks.”

56 attributes surfaced Results in 4 weeks

“I’ve been evaluating top-quartile solutions for the past year. Even the best ones don’t have what Tacit AI offers. The combination of AI-generated FMEAs, data quality scoring, and source traceability is unlike anything else available.”

FMEA + data quality Source traceability

Built for pharma leaders

For leaders who own uptime and quality.

For Manufacturing, Quality, Engineering, and Reliability leaders making controlled equipment-risk decisions.

Operating site

Close operating risk gaps

Work orders, deviations and CAPAs show if your baseline matches the line.

New or changed process

Build the pre-startup baseline

A pre-startup baseline from OEM manuals and qualification evidence.

Standards supported

Built to the methods you already use.

Structured to the frameworks your Quality unit already works in. Compliance decisions stay with the manufacturer.

21 CFR 210 / 211

21 CFR Part 11

EU GMP Annex 11

ALCOA+

EU GMP Annex 15

ICH Q9

ICH Q10

GAMP 5

ISO 14224

IEC 60812

SAE JA1011

Validation and AI governance

Built to pass your CSV/CSA review, not to bypass it.

We supply the documentation. Your Quality unit decides.

Tacit AI supplies

Validation support package

Specifications and traceability matrix
IQ/OQ support and PQ script templates
Part 11 / Annex 11 assessment inputs
Model, prompt, and release records

Your Quality unit owns

Classification, criteria, execution

GxP impact and risk classification
Validation plan and acceptance criteria
PQ execution in your environment
SOPs, periodic review, change control

Every output versioned with its model and sources. Nothing enters a controlled record without approval.

How you get there

One line this quarter. The whole site next year.

Start where the evidence is richest. Each system after starts ahead.

MONTH 1

Start with your equipment FMEAs

Bring one line's work orders, deviations and CAPAs. First draft in under 3 weeks.

MONTH 3

Deviations and CAPAs flow in weekly

Your engineer and QA approve each change once. Every comparable asset updates.

YEAR 1

Every line on one living baseline

The list shrinks every month. The next inspection is just another week.

Start with one line’s work orders, deviations and CAPAs.

Request a demo

Questions

Pharma validation and governance questions, answered.

Can Tacit AI run inside our validated environment?

Yes. Deploy in your VPC on Azure, AWS, or GCP, or on-premise, with a dedicated database. Phase 1 starts with bounded data extracts from your CMMS, QMS, and document system. Validated source systems are not modified. Integration is scoped after Phase 1 with your Quality and IT owners. See all 100+ connectors.

What validation documentation do you supply?

Functional and design specifications, a requirements traceability matrix, IQ/OQ support documentation, PQ test-script templates, Part 11 / Annex 11 assessment inputs, audit-trail specification, model and prompt version records, and release change-control notices. Your Quality unit owns GxP classification, the validation plan, acceptance criteria, and PQ execution, following GAMP 5 or your CSA approach.

How does this fit 21 CFR Part 11 and Annex 11?

Every record is attributable, legible, contemporaneous, original and accurate, plus complete, consistent, enduring and available: the ALCOA+ set. That means a full audit trail by user, record and operation. Role-based access. MFA through your identity provider. Versioned and attributed reviewer decisions. And complete data export. Your Quality unit classifies the records under Part 11 or Annex 11, and Tacit AI supplies the assessment inputs for that call.

How is AI use governed under GMP?

Nothing is final until an authorized reviewer accepts it. Model version, prompt, retrieval sources and confidence indicators are recorded per change and exportable. Model changes go through change control. Connect your enterprise LLM gateway (Azure OpenAI, AWS Bedrock, Google Vertex AI, internal endpoint) or use ours. Aligned with the EMA reflection paper on AI, FDA draft AI guidance and draft EU GMP Annex 22.

Does Tacit AI close deviations or decide CAPA effectiveness?

No. It connects deviations, CAPAs and events to the equipment-risk baseline, surfaces root-cause context with its source and flags every row that needs reassessment. Quality approves every change before it enters a controlled record.

Our CMMS data is incomplete. Is that a blocker?

No. Work order completeness, failure coding, and terminology are scored field by field before analysis, so gaps are visible rather than hidden. One fill-finish customer moved completeness from 32% to 73% under their own scoring method during the engagement. OEM manuals, SOPs, and qualification records fill context where records are thin.

Pharmaceutical FMEA software

Your equipment risk assessments keep themselves current.

New evidence, matched

One short list a week

Approve once, it reaches everything

Turn evidence into approved action.

Protect production

Connect CAPAs

Control revisions

Reuse approved work

Fit validated systems

Improve maintenance data

What changed in one fill-finish engagement.

What pharma reliability teams are saying.

For leaders who own uptime and quality.

Close operating risk gaps

Build the pre-startup baseline

Built to the methods you already use.

Built to pass your CSV/CSA review, not to bypass it.

Validation support package

Classification, criteria, execution

One line this quarter. The whole site next year.

Start with your equipment FMEAs

Deviations and CAPAs flow in weekly

Every line on one living baseline

Pharma validation and governance questions, answered.

Bring one line’s deviations.
See what your equipment FMEA is missing.

Pharmaceutical FMEA software

Your equipment risk assessments keep themselves current.

New evidence, matched

One short list a week

Approve once, it reaches everything

Turn evidence into approved action.

Protect production

Connect CAPAs

Control revisions

Reuse approved work

Fit validated systems

Improve maintenance data

What changed in one fill-finish engagement.

What pharma reliability teams are saying.

For leaders who own uptime and quality.

Close operating risk gaps

Build the pre-startup baseline

Built to the methods you already use.

Built to pass your CSV/CSA review, not to bypass it.

Validation support package

Classification, criteria, execution

One line this quarter. The whole site next year.

Start with your equipment FMEAs

Deviations and CAPAs flow in weekly

Every line on one living baseline

Pharma validation and governance questions, answered.

Bring one line’s deviations.See what your equipment FMEA is missing.

Bring one line’s deviations.
See what your equipment FMEA is missing.