Why Pharma Teams Choose PrimeInspect

Purpose-built audit management software and quality control inspection software for pharmaceutical manufacturers navigating GMP, FDA, and WHO compliance.

GMP Compliance Audits

  • Pre-built GMP audit templates (21 CFR, WHO GMP, EU GMP)
  • Customizable checklists for facility and equipment audits
  • Audit scoring with automatic pass/fail determination
  • Audit schedule management with automatic reminders

Batch Inspection & Sampling

  • Batch record inspection with electronic sign-off
  • AQL-based sampling for in-process and finished goods
  • Raw material incoming inspection workflows
  • Full batch traceability from raw material to release

Audit Trail & Documentation

  • Tamper-proof, time-stamped audit trail on all records
  • Electronic signatures for 21 CFR Part 11 compliance
  • One-click regulatory-ready PDF report generation
  • Centralized document storage with version control

CAPA Management

  • CAPA raised directly from audit findings
  • Root-cause analysis with five-why and fishbone support
  • Corrective action tracking with owner and due date
  • Effectiveness review and CAPA closure verification

Key Features for Pharmaceutical Inspection

PrimeInspect gives pharma quality teams a structured audit management software platform — from configuring GMP templates to closing CAPA actions and generating regulatory-ready documentation.

Book a Demo
01

Configure GMP Audit Templates

Start from pre-built GMP, FDA, or WHO audit templates, or build your own. Add scoring criteria, mandatory evidence fields, and e-signature requirements. Deploy to inspectors in minutes — no IT involvement needed.

GMP Compliance
02

Conduct Batch and Facility Inspection

QA teams execute batch inspections, facility walkthroughs, and equipment audits on mobile or desktop. Every observation, photo, and signature is timestamped and stored in a tamper-proof audit trail.

Batch Inspection
03

Generate Regulatory-Ready Reports

Audit reports are generated with one click — formatted for FDA, WHO, or internal review. CAPA actions are tracked to closure. Regulators and auditors get complete, structured documentation with no manual compilation.

Audit Reports
Pharmaceutical Inspection Software

Achieve GMP Compliance with Digital Audit Management Software

PrimeInspect gives pharma quality teams the audit management software and inspection management software needed to stay audit-ready, meet GMP requirements, and close CAPA actions faster.

No credit card required · Free forever plan