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GxP Lifeline

The Cost of Disconnected Manufacturing Software for Life Sciences CDMOs


Image of a life sciences contract manufacturing professional using MasterControl’s contract manufacturing software on a tablet.

Seventy percent of manufacturers report that data quality problems are their biggest obstacle to artificial intelligence (AI) implementation. For life sciences contract manufacturers juggling multiple client products simultaneously, this data challenge isn't just a statistic—it's a daily reality that directly impacts client satisfaction and contract retention.

According to Deloitte Research, these problems with data quality, contextualization, and validation have become the most significant barrier to technological advancement—an issue particularly acute for contract development and manufacturing organizations (CDMOs) managing diverse client requirements across varying regulatory standards.

The Hidden Cost of Disconnected Data in Contract Manufacturing

Contract manufacturers face higher stakes when their data lives in separate worlds. Unlike traditional manufacturers producing consistent product lines, CDMOs pivot between different client specifications—often within the same facility and sometimes on the same day.

When your quality management system (QMS) can't talk to your manufacturing execution system, which in turn is disconnected from your enterprise resource planning (ERP) platform, the cost multiplies with every client product you manufacture. Production delays, documentation errors, and compliance risks don't just impact a single product line—they potentially jeopardize your entire client portfolio.

Ready to eliminate information black holes in your manufacturing operations? Download our free "Blueprint to Modernizing CDMO Manufacturing Operations" guide to see how leading CDMOs are connecting their critical systems.

The Multi-Client Challenge: Why Integration Is Harder for CDMOs

Contract manufacturers face unique integration challenges that traditional manufacturers don't:

  1. Variable specifications across clients:
    Each client brings different documentation standards, quality parameters, and regulatory requirements—all needing management within the same systems.
  2. Frequent changeovers:
    The need to quickly switch production between client products demands systems that can adapt to varied specifications while maintaining data integrity.
  3. Multi-regulatory environment:
    Managing products for different markets means juggling requirements of the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), and other regulatory bodies—often simultaneously.
  4. Client visibility expectations:
    Today's clients want real-time production status and quality metrics, requiring systems that provide this transparency.

When your contract manufacturing software consists of disconnected systems, operators and quality personnel waste valuable time manually transferring data, reconciling discrepancies, and creating audit trails across systems. That's time that should be spent creating quality products, not chasing paperwork.

3 Key Systems That Need to Talk to Each Other

For contract manufacturers, three systems form the backbone of operations, yet frequently operate in isolation:

  • Enterprise Resource Planning (ERP): Manages business operations, inventory, materials, planning, and financials.
  • Manufacturing Execution System (MES): Controls and documents the transformation of raw materials into finished goods.
  • Quality Management System (QMS): Manages deviations, corrective actions, quality events, training, and compliance documentation.

When these systems operate in silos, CDMOs face real-world challenges such as:

  • Materials received and logged in the ERP don't automatically update production availability in the MES.
  • Quality events identified in production don't trigger automated workflows in the QMS.
  • Training requirements tracked in the QMS don't prevent unqualified personnel from performing operations.
  • Equipment maintenance schedules don't coordinate with production planning.

The result? Manual workarounds, duplicate data entry, and inevitable human errors—all undermining the quality and efficiency CDMOs promise their clients.

Digitize production records. Eliminate system silos. Download our comprehensive guide to learn practical strategies for connecting your critical manufacturing systems.

How Contract Manufacturing Data Silos Impact Client Satisfaction and Retention

In contract manufacturing, client relationships are everything. When disconnected systems create inefficiencies, the impact on these relationships results in:

  • Delayed Time-to-Market: Manual reconciliation between systems adds days or weeks to production timelines, frustrating clients with tight market deadlines.
  • Reduced Transparency: Without connected systems, providing clients with real-time production updates becomes labor-intensive and often inaccurate.
  • Compliance Concerns: Disparate systems make maintaining consistent data integrity difficult, raising red flags during client audits.
  • Scalability Limitations: As client portfolios grow, disconnected systems become increasingly unmanageable, limiting your ability to take on new business.

In an industry where clients have increasingly sophisticated expectations and abundant options, these issues directly impact contract renewal decisions. Contract manufacturing solutions that enable data integration and visibility have become key differentiators when sponsors select manufacturing partners.

The Competitive Advantage of Real-Time Production Intelligence

Forward-thinking CDMOs are gaining competitive advantage by implementing integrated contract manufacturing software that connects enterprise systems with shop floor operations. These connected environments create "real-time production intelligence"—the ability to see, analyze, and act on manufacturing data as it's generated.

For contract manufacturers, connected systems deliver:

  • Error Reduction: Automated data transfer between systems eliminates manual entry errors that cascade through production.
  • Accelerated Batch Release: When quality systems connect to production systems, review cycles that once took days complete in hours.
  • Enhanced Client Communication: Connected systems enable real-time reporting to clients on production status and quality metrics.
  • Predictive Capabilities: Integrated data enables analytics that identify potential issues before they impact production.

One leading CDMO implemented an integrated manufacturing excellence solution and reduced documentation review times from three days to just four hours—significantly improving their ability to meet client timelines and strengthening their position as a preferred manufacturing partner.

Quality integrated. Paperwork eliminated. Learn how one contract manufacturer reduced review times by 85% with connected systems. Download our "Blueprint to Modernizing CDMO Manufacturing Operations" for the complete case study.

Building Your Path to Connected Contract Manufacturing Intelligence

Breaking down data silos in contract manufacturing requires a strategic approach:

  1. Start with the shop floor:
    Digitize paper-based production records to create the foundation for connected operations.
  2. Prioritize integration capabilities:
    When evaluating contract manufacturing software, look for solutions designed with open APIs and pre-built connectors to common life sciences systems.
  3. Implement in phases:
    Focus first on connecting the systems that cause the most manual work and compliance risk.
  4. Involve both IT and operations:
    Successful integration requires collaboration between technical teams and the operators who will use the systems daily.
  5. Measure and communicate value:
    Track key metrics before and after integration to demonstrate ROI to both stakeholders and clients.

The most successful CDMOs approach digital transformation not as a technology project but as a strategic business initiative that directly strengthens client relationships through improved efficiency, compliance, and transparency.

From Disconnected Contract Manufacturing to Data-Driven

In today's competitive life sciences contract manufacturing landscape, connecting disparate systems and extracting meaningful insights from manufacturing data has become a critical differentiator. CDMOs that break down data silos position themselves to win new business, retain existing clients, and operate more efficiently across their entire portfolio.

Higher throughput. Lower error rates. That changes everything. Download our "Blueprint to Modernizing CDMO Manufacturing Operations" to learn how successful contract manufacturers are creating seamless data flows across client portfolios.

References:

  1. "2025 Manufacturing Industry Outlook," by John Coykendall, Kate Hardin, and John Morehouse, Deloitte Research Center for Energy & Industrials, Nov. 20, 2024.
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MasterControl Inc. is a leading provider of cloud-based quality and manufacturing software for life sciences and other regulated industries. For three decades, our mission has been the same as that of our customers – to bring life-changing products to more people sooner. MasterControl helps organizations digitize, automate, and connect quality and manufacturing processes. Innovative MasterControl tools have a proven track record of improving product quality, reducing cost, and accelerating time to market. Over 1,100 companies worldwide use MasterControl solutions to streamline operations, maintain compliance, easily analyze and interpret large amounts of data, and visualize business insights in real time.


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