Validated PLM. Auditable by design.
Formula and CMC management, stability data, validation workflows, and regulatory documentation — unified with batch operations and 21 CFR Part 11 controls baked in.
Pharma lifecycle
How pharma products move through Enjen.
Stage names re-tuned to match how your operations actually run.
Stage 1 / 8
Concept
Ideation, briefs, and viability — captured in one place.
Capabilities
Built for the way pharma actually works.
Formula & CMC Management
Manage active/excipient ratios, in-process specs, and CMC dossier sections in one structured system.
- Multi-strength and multi-pack family management
- Side-by-side compare across formulation revisions
- CMC dossier sections (3.2.P) auto-assembled from spec data
Stability & Shelf-Life
Run stability protocols (ICH Q1A) with auto-scheduled pull points, results capture, and trend analysis.
- Long-term, accelerated, and intermediate study tracking
- Out-of-trend alerts before specifications are breached
- Shelf-life recommendation engine with statistical justification
Validation Workflows
IQ/OQ/PQ for equipment and process validation with versioned protocols and signed-off reports.
- Risk-based validation scoping (ICH Q9)
- Linked deviations and CAPA across studies
- Re-validation triggers from change-control events
Supplier Qualification
Qualify API and excipient suppliers with audit calendars, GMP certifications, and re-qualification triggers.
- Track GMP / ISO certifications and expiries
- Risk scoring on quality-event history
- Auto-flag spec drift across vendor lots
Compliance heatmap
Compliance, mapped to how the system actually works.
Compliance shouldn't be a project you tack on — it should be how the system works. Here's how Enjen PLM maps to the frameworks regulated manufacturers actually face.
"We cut our CMC change-cycle from 90 days to 23. The formulation, stability, and supplier change all moved through one workflow — no more email forwarding between QA, RA, and manufacturing."
PLM in other industries
Same platform, different verticals — see how Enjen fits adjacent operations.
See PLM built for pharma operations.
A pharma specialist will walk you through formulation control, validation, and audit readiness on your real-world workflows.