Pharma Compliance
Made Audit Ready
Meet FDA 21 CFR Part 11, EU GMP Annex 11, and WHO GMP requirements with validated systems, digital batch records, and complete, defensible audit trails.
Pharma Challenges
The Compliance Tightrope.
Stringent Global Convergence
Navigating FDA, EMA, and WHO GMP requirements simultaneously across global markets creates massive documentation overhead.
Data Integrity (ALCOA+) Pressure
Maintaining ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate) is nearly impossible with paper-based systems.
The "Hybrid System" Risk
Managing "paper on glass"—where digital systems still rely on wet-ink signatures—creates broken audit trails and validation gaps.
Four Pillars of GxP Excellence
FDA-validated systems built for pharmaceutical manufacturing and quality.
21 CFR Part 11 Validated
Secure electronic records and signatures.
Electronic Batch Records (eBMR)
Move to "Review by Exception."
QMS: Change Control & CAPA
Systematic quality improvement.
Data Integrity (ALCOA+)
Uncompromised compliance architecture.
Who Uses DBOMS in Pharma?
API & Drug Manufacturers
FDA 21 CFR Part 11 compliance for Batch Records and Lab Data.
Contract Manufacturing (CMO/CDMO)
Segregated "Multi-Tenant" QMS for managing different client products securely.
Packaging & Labeling
Managing artwork versions, serialization records, and label reconciliation.
Pharmaceutical Compliance FAQs
Common questions from API manufacturers, drug companies, and CMOs about DBOMS.
Ready to Achieve FDA Compliance?
See how DBOMS helps pharma companies maintain Data Integrity and Audit Readiness.