Case Study: The Impact of Product Lifecycle Management (PLM) in the Pharmaceutical Industry

The pharmaceutical industry is characterized by its complexity, stringent regulatory requirements, and the critical need for innovation. As companies strive to bring new drugs to market faster while ensuring compliance and quality, the implementation of Product Lifecycle Management (PLM) systems has emerged as a transformative solution. This case study explores how PLM systems enhance efficiency, collaboration, and compliance in pharmaceutical companies, ultimately leading to improved patient outcomes.

Pollux was approached by a well known Pharmaceutical company to help them with their production/delivery process, specifically with concerns pertaining to their bill of materials (BOM), especially in a multi plant/multi city environment. They were finding issues with managing details of specific items that make up the parent drug.

We were expected to build a centralized system that can track non-stock, bulky items along with production notes and issues. The system had to be lean and capable of handling vast amounts of data which could serve as a single source of truth.

Team Pollux identified the specific pain points of the customer

Complexity Among Plants: BOMs for the same product differed depending on the equipment or somewhat different methods used by various plants of the client. Coordination became difficult as a result, as factories were spread across multiple regions and had distinct regulatory needs (such as FDA vs. EMA requirements).

Regulatory Compliance: BOMs must adhere to all applicable laws, including Good Manufacturing Practices (GMP), which were different depending on the market. Errors occurred when this was managed manually across several plants.

Data Integrity and Version Control: BOMs were revised across several production locations leading to confusion and error. Maintaining data integrity and monitor BOM changes (such as changes in ingredient quantities, substitutes, or process adjustments) was getting difficult. Disparities in BOM across locations were creating confusion in procurement process

Collaboration and Communication: Inconsistent BOM data frequently prevented R&D, production, and supply chain teams in various locations from working effectively together, which can resulted in inefficiencies or quality problems.

At Pollux, we had just the system to mitigate these issue from happening and making life easier for the customer

The answer was Pollux PLM!

Objective - Create a solution with which you can create and maintain digital product information throughout the enterprise and for the entire product life cycle to manage manufacturing processes. Our PLM combines the management of product and process data with other applications.

The Specifics

Team Pollux had the solutions in it’s PLM. These solutions are customizable based on the client’s needs. Pollux PLM has detailed BOM management capabilities, allowing users to control and track BOM structures, versioning, and changes across multiple plants. It also supports complex multi-level BOMs.

Centralized BOM Repository

A centralized data hub where all BOMs are stored and maintained in a single, unified platform. This ensured that all plants access the same up-to-date version of the BOM, reducing errors caused by discrepancies between different sites.

BOMs for each product were stored in a standardized format, making it easier to track, compare, and update them as needed. Pollux PLM can store the raw materials information like batch sizes, packaging details, regulatory documentation, and manufacturing steps, ensuring comprehensive visibility.

Version Control & Traceability:

Version control ensured that all changes to a BOM (such as ingredient substitutions, process changes, or packaging alterations) are logged with an audit trail. This provided full traceability of changes across all plants. if a change is made to the BOM for a new formulation, the PLM system ensured that all manufacturing sites are informed and the correct version was used, preventing errors from outdated or inconsistent BOMs.

Product Standardization Across Plants:

PLM systems helped standardize BOMs across multiple plants. While some minor plant-specific adaptations (e.g., equipment or local supplier constraints) were still be necessary, the core BOM was standardized across all sites. This ensured that product formulations, regulatory documentation, and quality standards were consistent, regardless of which plant manufactured the product.

In case of a formulation change, the PLM system automatically pushed updates to all affected plants, ensuring consistency across all manufacturing sites and avoiding discrepancies in the BOM.

Regulatory Compliance & Quality Management:

PLM systems integrated with regulatory compliance modules, ensuring that any changes made to the BOM adhered to local regulations. For example, the system validated that raw materials are sourced from approved suppliers and complied with GMP, ICH, or FDA regulations.

The PLM system tracked regulatory filings related to BOM changes (such as new excipients or packaging materials) and automatically linked the BOM to the corresponding regulatory submission, ensuring a seamless compliance process.

Collaboration & Cross-Functional Integration:

PLM enabled real-time collaboration among R&D, production, quality assurance, regulatory affairs, and supply chain teams, even if they were located in different plants or regions. These teams worked with a single source of truth for BOMs, reducing miscommunication and ensuring everyone is on the same page.

For example, if the R&D team modified a formula in one plant, the new BOM was communicated instantly to other plants for review and validation before implementation, streamlining cross-functional collaboration.

Integration with ERP and MES Systems:

PLM systems can integrate with ERP (Enterprise Resource Planning) and MES (Manufacturing Execution Systems). This integration allows for smoother coordination of the BOM with procurement, inventory, and manufacturing systems.

For instance, when the BOM is updated in the PLM system, the ERP system can automatically adjust inventory levels or initiate procurement orders for the new raw materials, preventing stockouts or overstocking.

Change Management and Impact Analysis:

When changes were made to a BOM (e.g., a change in the supplier of an active pharmaceutical ingredient), our PLM system enabled the change management processes. This included automatic impact analysis to assess how the change affects other areas like production, supply chain, and regulatory approvals.

Our systems flagged potential regulatory impact and helped coordinate the necessary filings or certifications required before the new BOM is approved for use at all sites.

Supply Chain Optimization:

With standardized BOMs across plants, our client was able to better manage their global supply chains. Since the BOM is consistent, it simplified raw material procurement and inventory management across multiple regions, reducing lead time, minimizing waste, and ensuring that the right materials are available at the right time for production.

Simulation & What-If Scenarios:

Our PLM systems can help simulate different scenarios when modifying a BOM (e.g., testing how a new material or formulation affects cost, supply, or production capacity). This allowed plants to evaluate the impact of changes before implementing them, reducing the risk of production disruptions.

Outcomes

The implementation of Pollux PLM system yielded significant improvements across multiple dimensions.

Our client achieved better consistency in product formulations, improved regulatory compliance, and reduced manufacturing errors due to BOM discrepancies. The integration with ERP systems also streamlined raw material procurement and production scheduling, leading to improved supply chain efficiency.