PLM Implementation for Life Sciences Manufacturers

Navigate GMP requirements, validation protocols, and formula management. From R&D through clinical trials to commercial manufacturing—traceability for drug products, biologics, and combination products.

Life sciences manufacturing operates under the most stringent regulatory requirements in any industry.

Life sciences manufacturing operates under the most stringent regulatory requirements in any industry.

Life sciences manufacturing operates under the most stringent regulatory requirements in any industry.

Good Manufacturing Practice (GMP) regulations govern every aspect of production. Formula management requires absolute precision. Clinical trial materials must be traceable to batch and lot. And validation protocols demand documented evidence of system reliability.

Generic PLM implementations fail life sciences manufacturers because they don't understand formula management complexity, GMP documentation requirements, or the reality that your products require FDA approval with complete traceability from raw materials to patient dosing.

Element Consulting is developing specialized PLM capabilities for life sciences manufacturers. Our approach addresses formula management, GMP compliance, validation requirements, batch traceability, and integration with ERP systems designed for life sciences (SAP, Oracle, Veeva).

Life Sciences Case Studies

+64%

User adoption improvement in 6-month PLM rescue program for aerospace manufacturer.

+64%

User adoption improvement in 6-month PLM rescue program for aerospace manufacturer.

+64%

User adoption improvement in 6-month PLM rescue program for aerospace manufacturer.

-81%

Change order cycle time reduction through automated PLM-ERP integration.

-81%

Change order cycle time reduction through automated PLM-ERP integration.

-81%

Change order cycle time reduction through automated PLM-ERP integration.

67%

Reduction in manufacturing errors after implementing digital work instructions and change management.

67%

Reduction in manufacturing errors after implementing digital work instructions and change management.

67%

Reduction in manufacturing errors after implementing digital work instructions and change management.

*Results reflect specific project implementations and may vary based on organizational factors and scope.

What makes us different:

Three things our clients mention when they refer us:

Partnership, not information

  • We don't just deliver reports and leave

  • We guide you through decisions (not just present options)

  • We stay until it's working (not just technically live)

  • We make sure you can sustain it (not dependent on us forever)


That's why clients call us partners, not vendors.

  • We don't just deliver reports and leave

  • We guide you through decisions (not just present options)

  • We stay until it's working (not just technically live)

  • We make sure you can sustain it (not dependent on us forever)


That's why clients call us partners, not vendors.

Process-First Integration

73% of integrations fail from technology-first approaches.


We start with how your people actually work. Including the workarounds. Including the Excel sheets. Including the guy who knows where everything really is.


Then we build integration to match that reality.


Technology last, not first.

73% of integrations fail from technology-first approaches.


We start with how your people actually work. Including the workarounds. Including the Excel sheets. Including the guy who knows where everything really is.


Then we build integration to match that reality.


Technology last, not first.

OCM Adoption

What happens when you strip it:

  • Technology works perfectly

  • Users revert to Excel within 3 months

  • $2M investment sits unused

  • 39% adoption (industry average)


What we do differently:

  • OCM is mandatory, not optional

  • Change champions in each department (not just training)

  • Measure adoption, not just implementation

  • Fix what's not working (not just "go-live and hope")

What happens when you strip it:

  • Technology works perfectly

  • Users revert to Excel within 3 months

  • $2M investment sits unused

  • 39% adoption (industry average)


What we do differently:

  • OCM is mandatory, not optional

  • Change champions in each department (not just training)

  • Measure adoption, not just implementation

  • Fix what's not working (not just "go-live and hope")

FAQ

Can PLM support tech transfer from R&D to commercial manufacturing?

What's the timeline for life sciences PLM implementation?

How do you handle formula management for drug products and biologics?

Can PLM handle clinical trial material management?

How does PLM support FDA GMP requirements for pharmaceuticals?

What makes life sciences PLM different from medical device PLM?

Ready to Transform Your PLM System?

Get in touch

Ready to Transform Your PLM System?

Schedule a consultation with our PLM specialists. We'll assess your integration challenges, identify quick wins, and show you what 88% success rate looks like.

Get Started

Ready to Transform Your PLM System?

Schedule a consultation with our PLM specialists. We'll assess your integration challenges, identify quick wins, and show you what 88% success rate looks like.

Get Started

Ready to Transform Your PLM System?

Schedule a consultation with our PLM specialists. We'll assess your integration challenges, identify quick wins, and show you what 88% success rate looks like.

Get Started