Pharmaceutical & CDMO eQMS Solution
Pre-Configured for ICH Q7–Q10, 21 CFR 210/211 & EU GMP Annex 11
Engineered specifically for drug manufacturing operations, API facilities, and contract manufacturers. Pre-seeded with Qualified Person (QP) release workflows, batch deviation templates, and environmental monitoring log governance.
What Gets Activated Instantly at Onboarding
Pre-Seeded Industry Roles
- Qualified Person (QP)
- Head of Quality Assurance
- QC Laboratory Lead
- Production QA Specialist
Document Types & Numbering
- Master Batch Records (MBR)
- Standard Operating Procedures (SOP)
- Analytical Test Methods (ATM)
- Validation Protocols
Risk Assessment Matrix
ICH Q9 Quantitative Matrix (5x5 FMEA with Critical Severity Dominance)
Pre-Built Workflow Lifecycles
Batch Release Approval Loops, Out of Specification (OOS) Investigations, Annual Product Quality Reviews (PQR)
Operational Advantages for Your Sector
Eliminate batch release delays with automated cross-functional deviation sign-offs.
Out-of-Specification (OOS) investigation workflows with Phase I laboratory check triage.
Zero unqualified operators: batch record SOP updates automatically trigger LMS qualification.
Complete ALCOA+ data integrity with PostgreSQL cryptographic audit hash chains.
Launch Your Turnkey Pharmaceutical & CDMO eQMS Solution
See the exact pre-configured GxP workflows, templates, and qualification evidence designed for your sector.