Digitizing Pharma Product Lifecycles with a Unified PLM Platform

Project Solution

INNERLUXES delivered a unified PLM platform that centralized formulation, API, packaging, and regulatory workflows — automating change control, strengthening compliance, and improving visibility to accelerate product development and reduce operational errors.

The Client

The Client is an international pharmaceutical company known for producing a wide range of branded and generic medicines distributed globally. It relied on INNERLUXES to modernize a complex product development process. With a large global product portfolio, the Client faced growing challenges managing formulations, ingredient data, and packaging standards while ensuring compliance with stringent global health regulations.

The Challenge

The Client's product development processes were fragmented, leading to:

• Disconnected formulation development: R&D departments tracked formulas in spreadsheets and LIMS with no central version control, making even minor process changes costly and risky to apply across multiple systems.
• API specification silos: API testing procedures, supplier information, and certificates were stored in separate repositories, and outdated API specifications caused batch and quality-control delays.
• Packaging & artwork bottlenecks: label and carton artwork were handled manually by global packaging teams and rarely updated with regional specifics, with each compliance failure costing weeks of re-work and regulatory submissions.
• Regulatory & audit challenges: change requests weren't directly connected to dossiers or filings, so audits took days of document collation — a major issue in a business where traceability is critical.

The Approach

The goal was to link all elements of the pharmaceutical lifecycle — from formulation to packaging through regulatory release — via one tested PLM environment. INNERLUXES collaborated with the R&D, regulatory, and quality teams to map the current workflow, identify redundancies, and design a digital thread that provided traceability and compliance at every level.

The Solution

INNERLUXES designed and implemented a drug-grade Product Lifecycle Management (PLM) system, built with global drug formulation and packaging processes in mind, to turn complex workflows into a cohesive, data-driven platform.

Core functionalities:

• Formulation & API data management: all formulations, excipients, and API specifications are stored in a centralized, version-controlled PLM repository. Every update triggers an automated impact analysis to keep associated formulations, BOMs, and dossiers up to date.
• Packaging artwork automation: digital artwork workflows replaced manual revisions, letting regional teams review, approve, and archive packaging and label designs through automated version control and regulatory sign-offs.
• Change control automation: an end-to-end ECR/ECO workflow connects the PLM system with SAP ERP. Once a change is approved, the Bill of Materials and production records update automatically, eliminating manual steps and minimizing errors.
• Regulatory compliance module: built to meet FDA 21 CFR Part 11, GxP, and ICH Q10 standards, ensuring complete data integrity with e-signatures, audit trails, and submission-ready reports.
• Analytics & reporting dashboard: a Power BI-driven interface gives leadership a real-time view of launch readiness, supplier certifications, and change-control cycles.

The Results

• Unified digital thread: connected formulation → packaging → market release.
• Compliance confidence: reduced audit prep from 10 days to under 2.
• Speed to market: accelerated product launches by up to 50%.
• Reduced risk: improved traceability of ingredients, suppliers, and formulations.
• Cost savings: minimized rework and non-compliance penalties.

Technologies and Tools

Pharma-grade PLM platform, LIMS & SAP ERP integration, digital artwork & label management, Power BI analytics dashboard, e-signature & audit-trail automation, regulatory compliance module (FDA 21 CFR Part 11, GxP, ICH Q10).