Skip to content

PHARMACEUTICAL QUALITY MANAGEMENT

Make every quality decision traceable.

Investigate deviations and OOS/OOT, verify CAPA effectiveness, review batches and prepare inspection responses—with evidence, ownership and human review connected.

Interactive tour · Sample records · No customer data

BAYESPEAQ / QUALITY CASE PREVIEWSample record
DEV-041 · B24091

Temperature excursion

Evidence needed
OPEN QUALITY QUESTION

Was the probe calibration current at the time of the excursion?

The conclusion remains limited until the exact calibration record is verified.

Exact revision under reviewTEMP-12 · Rev 02
Evidence still requiredProbe calibration record
Next accountable roleInvestigator
Source identified · InvestigatorThe controlled temperature log and revision remain visible for review.
Open linked stage →

A single case excerpt keeps the evidence gap, owner and next action readable.

Product tour · choose your workflow

Start with the quality work you need to do.

Your selection stays active as you move through the tour and role views. Every example is read-only sample data.

LAB / OOS-017 · SAMPLE RECORD

Investigate without erasing uncertainty.

Preserve the original result and testing rationale while comparing hypotheses against supporting and contradicting evidence.

RESPONSIBLE ROLESQC Analyst → Investigator → QA Reviewer
Inspect investigation
OOS-017 / INVESTIGATIONREAD-ONLY
ChronologyOriginal result → review → hypothesis testing
Hypothesis AInstrument drift · supporting evidence incomplete
ContradictionCalibration record not yet verified
Reviewed conclusionNot ready
Illustrative example · No customer dataSelection is preserved while you explore this page

Product tour · selected workflow: Investigate OOS/OOT

Follow the evidence from signal to accountable decision.

The selected workflow stays in context while you inspect evidence, ownership, review gates and the Decision Passport. Sample data only; no customer records.

Sample record · read-only
Stage 1 of 7 · Event raised

Inspect every step · sample records only. No approvals take place.

01 / 07 · Illustrative quality case

A quality signal becomes an owned record.

An excursion is reported with a controlled identifier, product context and initial owner. No conclusion is invented at intake.

BayesPeaQ / DEV-041READ-ONLY DEMO
RecordDEV-041 · Temperature excursion
BatchB24091 · Illustrative
StatusOpen · triage
Next action: investigator checks what evidence is available.
01 / 07 · Event raised

Core pharmaceutical quality workflows

Six reasons to evaluate BayesPeaQ.

Each workflow exposes a practical outcome, a small evidence example and the accountable next action—without hiding the review boundary.

INVESTIGATIONS / OOS-OOT

Investigations

Build chronology, compare competing hypotheses and preserve supporting and contradicting evidence.

OOS-017
Calibration evidence missingConclusion limited
Inspect an investigation →
EFFECTIVENESS

CAPA effectiveness

Separate implementation from effectiveness criteria, observation period, collected evidence and reviewed outcome.

CAPA-011
18 / 30 observation daysReview pending
Explore effectiveness →
MANUFACTURING QUALITY

Batch review

Reconcile manufacturing and laboratory evidence with linked investigations, holds and document currency.

B24091
OOS-017 linkedDisposition blocked
Inspect batch review →
PERIODIC REVIEW

APQR

Review a reconciled batch population against a persisted source freeze, then track section review and follow-ups.

APQR / 2026
24 batches · source set frozenSection review
Inspect an APQR example →
DOCUMENT GOVERNANCE

Documents & qualification

Connect SOP revisions to affected roles, retraining, competency evidence, expiry and effective authority.

SOP-QA-014 · Rev 04
3 affected roles1 retraining due
Review qualification flow →
INSPECTION READINESS

Inspection response

Own requests and deadlines, review responses, control sharing and reconstruct what was known at the decision date.

INSP-009
Response due 09 OctQA review pending
Inspect a response →
Additional capability directory
Change control · Supplier quality · Complaints · Quality risk · Recall readiness

Available according to tenant configuration, role permissions and intended use.

Qualified integrations

Current MES adapter scope is customer-specific: connection and qualification must demonstrate object-level and field-level reconciliation, corrections, duplicates and retries. Do not infer verified LIMS or ERP qualification from this example.

Same record · materially different work

See the handoff through each accountable role.

The case identity stays consistent. The task, permitted action and responsibility change with the role.

Selected workflow: Investigate OOS/OOT

My Work / Investigation

Resolve the evidence gap.

Priority: High · Due: Today · Blocker: calibration record.

Next action: verify the exact source before proposing a determination.

DEV-041 · INVESTIGATOREvidence gap
Accountable owner Investigator
Source required CAL-PROBE-17
Permitted action Verify evidence →

Navigation rule illustrated here: Quality Contributors lead with My Work; other authorized QMS manager/head roles can use Mission Control + My Work. Actual access remains tenant- and role-controlled.

Evidence → assistance → verification → decision

Inspect the reasoning, not just the status.

BayesPeaQ keeps AI assistance inside the evidence trail while accountable people retain review and decision authority.

DEV-041 / DECISION CONTEXTSample record · read-only
CONTROLLED EVIDENCE

Exact source identity and revision stay visible.

TEMP-12 · Rev 02 is under review. CAL-PROBE-17 is still required, so the evidence set is incomplete.

Exact revision under reviewTEMP-12 · Rev 02
Evidence still requiredCAL-PROBE-17

Illustrative workflow only · not customer records, an electronic signature or qualification evidence.

For evaluators and validation leads

Evaluate the workflows your quality team actually uses.

Use a focused walkthrough to review scope, intended use, your configuration and the evidence needed for a responsible deployment decision.

01

Walk your workflow

Show the records, investigation steps, approval roles and review gates relevant to your operation.

02

Confirm the boundaries

Discuss access roles, tenant configuration, integrations, data flow and records that remain external.

03

Review qualification evidence

Request applicable testing, release and integrity evidence for your own validation assessment.

Request a workflow-specific walkthrough.We can review your workflow, relevant records, role handoffs, integration scope and qualification evidence.Selected workflow: Investigate OOS/OOT

Request walkthrough ↗

A few useful answers

Before you
step inside.

Who is BayesPeaQ for?

Pharmaceutical quality teams working across quality events, investigations, CAPA, change control and quality review. Workspace access depends on your organization’s assigned Quality role.

Can AI make or approve quality decisions?

No. AI helps organize and compare evidence, surface context and identify gaps. Authorized people retain final quality decisions, signatures, release and closure authority.

Which workflows can my team evaluate?

Start with deviation investigation, evidence inspection, CAPA effectiveness and your authorized QA decision paths. Discuss additional scenarios such as APQR, batch disposition, recall readiness and management review according to your intended use and tenant configuration.

Can we review qualification and electronic-record controls?

Yes—review applicable release, test, access-control and evidence-integrity materials for your own risk-based validation. Visit Trust & Validation for framework context; product features alone do not establish compliance.

How would integrations and tenant setup work?

Discuss source systems, record types, controlled import paths, organizational roles and configuration with the Bayes Pharma team before determining suitability.

Request a workflow-specific walkthrough →
Do I need to install an app?

No. Use BayesPeaQ in your browser, or install the web app on a supported desktop or mobile browser for quicker access. Controlled quality records still require an authenticated connection.

How do I access my workspace?

Sign in with your platform account. BayesPeaQ checks your session and Quality role before opening the workspace. Contact your organization’s administrator if you need access.

Sign in to BayesPeaQ

Quality management built for evidence

Build a quality system you can defend.

Bring investigations, evidence, CAPA, approvals, quality decisions and inspection history into one governed system—then assess its suitability against your intended use and validation requirements.

Desktop + mobile

BayesPeaQ, one click closer.

Use your browser’s Install app option to add BayesPeaQ to this device.

Installation adds the app shell. Controlled quality records remain online and require authenticated access.