PLM Implementation for Life Sciences Manufacturers

If you manufacture combination device-drug products, our medical device expertise provides immediate value for the device portion, and we're building life sciences capability for the drug portion. For pure pharmaceutical or biologics companies, life sciences-specific consultants may be better suited today. However, if you engage during our development phase, you'll help shape our life sciences methodology—and get preferential early adopter pricing.

Absolutely—that's a major PLM value for life sciences. R&D develops formulas at lab scale, pilot scale, then commercial scale. PLM manages formula evolution, scale-up parameters, process validation data, and equipment specifications through each phase. When you transfer to commercial site, complete manufacturing knowledge transfers digitally—not in binders and tribal knowledge.

Validated systems take longer than unvalidated ones, about as long as medical device programs, because of FDA validation requirements. Validation protocols (IQ/OQ/PQ), CSV (computer system validation), and integration with manufacturing systems take time. Life sciences can't rush validation—regulatory risk is too high. We'll design implementations that balance speed with compliance rigor.

PLM manages master formulas (recipe), ingredient specifications (API, excipients), process parameters (mixing time, temperature, pressure), equipment requirements, and analytical methods. Version control ensures production always uses approved formula. Changes trigger review and revalidation workflows. Integration with ERP generates batch production orders from PLM formulas.

Yes—this is critical for life sciences. PLM manages clinical trial protocols, tracks investigational product formulations, maintains CTM batch records, provides lot-to-patient traceability for adverse event investigation, and manages changes between clinical phases (Phase 1 → 2 → 3 formulation evolution). When you transition to commercial manufacturing, clinical data comes with you.

PLM provides formula management with complete version control, batch record generation with electronic signatures, change control with deviation management, validated computer systems (21 CFR Part 11), and complete traceability from raw materials to finished product. Integration with ERP (SAP, Oracle) and manufacturing execution systems ensures production follows approved formulas exactly.

Life sciences focuses on formula/recipe management (drug products, biologics) vs discrete product design (devices). GMP requirements are similar but applied differently—batch records vs device history records, API/excipient traceability vs component traceability, process validation vs design validation. Combination products require managing both paradigms simultaneously.

We're building the practice now. If you make combination products, talk to us about the device side today, where our medical device experience applies directly. If you're evaluating PLM for pharmaceutical or biologics manufacturing, we'd like to understand your specific formula management and GMP requirements.