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ParaTechParaTechPharma ERP
Quality Assurance

Quality at Every Step — Built for Regulators, Trusted by Plants

Every test, every release and every deviation is recorded — and ready for DRAP, WHO-GMP or USFDA audit at any moment.

Compliance is non-negotiable.

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Quality · QA Release Workflow
Release PipelineOOS / OOTCAPA
PCM API · Batch PCM-API-0117
QA Review
  1. Received
    Quarantine — no consumption
  2. Under Test
    Sampled per AQL plan
  3. QA Review
    Test record validated & signed
  4. Released
    Quarantine → Approved
  5. Available
    Visible to MRP · FEFO-allocated
No material moves without QA approval — 21 CFR Part 11-ready signatures.
Capabilities

What this module delivers

Purpose-built features that map directly to how pharmaceutical operations actually run.

QC Test Templates

Pharmacopoeia-ready (USP/BP/IP/EP), versioned and configurable.

Quality Gates

No material moves without QA approval.

QA Release Workflow

Quarantine → tested → reviewed → released → available.

OOS / OOT Management

Auto-flag, investigate and disposition with audit trail.

CAPA Tracking

Corrective and preventive actions tracked to closure.

Certificate of Analysis

One-click, client-branded, multi-format CoA.

Stability Studies

ICH-aligned conditions, pull schedules and shelf-life decisions.

Supplier & Instrument QA

Supplier scorecards and instrument calibration register.

OOS / OOT Management

Out-of-spec results, investigated not ignored

A structured workflow takes every out-of-specification result from auto-flag through investigation, disposition and CAPA linkage with a full audit trail.

OOS investigation workflow
1
Auto-Flag at Entry
Result outside spec triggers OOS
2
Lab Investigation
Phase I: analyst, instrument, calc
3
Full Investigation
Phase II: root cause & retest plan
4
Disposition
Reject, rework, reprocess or release
5
CAPA Linkage
Findings drive corrective actions
Certificate of Analysis

One click, audit-ready CoA

Client-branded, multi-format Certificates of Analysis with digital signatures and a locked audit trail, versioned and archived for years.

  • Pharmacopoeia methods (USP / BP / IP / EP)
  • ICH-aligned stability studies with OOT alerts
  • Supplier QA scorecards & instrument calibration
  • 21 CFR Part 11-ready electronic signatures
Quality · Certificate of Analysis
CoAStabilityTemplates
Paracetamol Tablets 500mg
Batch PCM-26-0117 · 250,000 Tablets
Released
TestSpecificationResultStatus
DescriptionWhite uncoated tab.ConformsOK
Assay (%)95.0 – 105.099.4%OK
Dissolution80% @ 30 min94%OK
Hardness (kp)4.0 – 8.06.2OK
Disintegration15 min9.4 minOK

Released by QA Manager · Signed Electronically · Audit Trail Locked · Multi-format export (PDF / Word / Excel)

Related Workflows

Connected, end-to-end

  • Goods receipt → QC sampling → QA review → QA release → available for production
  • OOS workflow: auto-flag → investigation → disposition → CAPA linkage
  • Stability: pull schedule → CoA per timepoint → OOT alert → shelf-life
  • Pharmacopoeia method library with tolerance-driven OOS detection
Business Value

Why it matters

  • DRAP / WHO-GMP / USFDA audit readiness
  • Auto OOS detection on result entry
  • Full deviation and CAPA closure tracking
  • 21 CFR Part 11-ready electronic signatures
One Platform

Connected modules

Inventory ManagementEvery batch, every bin, every expiry — under one system.ManufacturingPlan it. Make it. Cost it. Trace it.Contract ManufacturingToll & contract manufacturing — built in, not bolted on.
Get Started

Schedule Your Pharma ERP Demonstration

See ParaTech Pharma ERP in action on your real-world scenarios — batch traceability, QA release, FBR invoicing and batch profitability.

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