How Life Sciences Companies Reduce MES Validation Time By 80%

Four months for validation? Try 45 minutes instead.

In the highly regulated life sciences industry, software validation remains one of the most significant hurdles to implementing new technologies. Manufacturing execution systems (MES), which are essential for modernizing production processes, often face lengthy implementation delays due to regulators' validation requirements. The good news? Savvy companies are now slashing validation times by up to 80% through innovative approaches and tools designed specifically for cloud-based environments.

The Validation Burden in Life Sciences Manufacturing

For regulated companies who implement a manufacturing execution system, validation can consume enormous resources. Traditional approaches often require extensive documentation, repetitive testing, and lengthy approval cycles. It's not uncommon for validation activities to stretch across four months or longer for the implementation of a single computer system.

The challenge becomes even more daunting in some cloud environments. While on-premises software might require validation every few years, cloud-based manufacturing execution software typically releases updates quarterly. Without an optimized validation strategy, production and quality teams can find themselves in a perpetual validation cycle that diverts valuable resources from other critical activities.

A New Paradigm for MES Validation

The U.S. Food and Drug Administration (FDA) has long advocated for a risk-based approach to validation, as outlined in their "Pharmaceutical cGMPs for the 21st Century" initiative.¹ This philosophy encourages companies to focus validation efforts on aspects that present the highest risk to product quality and patient safety.

Building on this foundation, MasterControl has developed a streamlined methodology for manufacturing execution system validation that can dramatically reduce the time and resources required to validate an MES while maintaining compliance with regulatory requirements.

The 8 Best Practices for Quick and Compliant Validation

Based on over two decades of experience working with regulated companies, these validation best practices can transform how life sciences organizations approach MES validation:

1. Leverage Supplier Documentation

Software providers, particularly those offering software-as-a-service (SaaS) solutions, typically produce extensive validation documentation as an integral part of testing their products. Both the FDA and industry guidance (like GAMP 5) recommend leveraging this supplier documentation rather than recreating everything from scratch.

The GAMP 5 guidance notes that regulated companies should seek to maximize supplier involvement throughout the system life cycle in order to leverage knowledge, experience, and documentation, subject to satisfactory supplier assessment.²

2. Include Supplier's Usage Testing

Leading manufacturing execution software providers perform comprehensive functional testing before each release. By incorporating this testing into your validation package, you can avoid duplicating efforts while ensuring system quality.

3. Follow Industry Best Practices for Configuration

While customization offers flexibility, it significantly increases validation complexity. Adopting the best practice configurations recommended by an MES provider with a proven track record of validation excellence can drastically reduce implementation time and simplify future validation efforts.

4. Conduct Risk-Based Assessment of Your MES Configuration

Not all aspects of a manufacturing execution system carry equal risk. A thorough risk assessment based on your specific configuration and usage patterns allows you to focus validation efforts where they matter most.

5. Focus on Critical Business Processes

Instead of validating every possible function, concentrate on the critical business processes that directly impact product quality and regulatory compliance. This targeted approach ensures comprehensive coverage of high-risk areas while eliminating unnecessary testing.

Ready to transform your software validation process? Download the complete guide to compliant and quick software validation for in-depth strategies.

6. Implement True Risk-Based Validation

Many organizations claim to follow risk-based validation while still treating every system aspect as high-risk. Authentic risk-based validation requires identifying genuinely critical areas and focusing resources accordingly.

As the FDA guidance on software validation states: "The selection of validation activities, tasks, and work items should be commensurate with the complexity of the software design and the risk associated with the use of the software for the specified intended use."³

7. Use Change Control Methodology for Updates

Instead of performing complete revalidation for minor upgrades, implement a change control methodology that allows for targeted validation of modified features. This approach reduces documentation overhead and streamlines the approval process.

8. Upgrade Frequently

While counterintuitive, frequent upgrades with smaller validation efforts are more efficient than infrequent, massive validation projects. Regular updates keep systems current with the latest features and security enhancements while maintaining a manageable validation workload.

The Validation Excellence Tool: A Game-Changer for MES Validation

With the recognition of the FDA, MasterControl developed the Validation Excellence Tool (VxT), a patented solution that quantifies and streamlines risk-based validation. This revolutionary tool:

• Assesses configuration variations from best practices.
• Evaluates regulatory sensitivity of customer usage.
• Determines how well configurations are covered by internal testing.
• Generates customized risk-based protocols tailored to specific usage patterns.
• Produces consolidated validation documentation through a well-established change control approach.

For manufacturing execution system implementations, VxT has demonstrated remarkable results. What once required months of effort can now be completed in days or even hours. For system upgrades, the validation time has been reduced to as little as 45 minutes in some cases – an efficiency improvement that transforms how life sciences companies approach their manufacturing technology strategy.

Real-World Impact on Manufacturing Operations

The implications for life sciences manufacturing are profound. Companies adopting these validation best practices report:

• Accelerated Digital Transformation: With validation no longer serving as a barrier, life sciences organizations can implement manufacturing execution systems faster, driving operational excellence sooner.

• Reduced Total Cost of Ownership: Streamlined validation significantly reduces the personnel hours required for system maintenance, lowering the total cost of ownership for manufacturing execution software.

• Improved Compliance: Counterintuitively, focused validation efforts often yield better compliance outcomes by ensuring critical areas receive appropriate attention rather than spreading resources too thin.

• Enhanced Agility: When validation can be completed quickly, organizations become more willing to adopt updates that introduce valuable new features or address security concerns.

How to Get Started

If your organization is struggling with lengthy, resource-consuming MES validation processes, consider these steps:

1. Evaluate Current Validation Practices: Compare your existing validation approach against the eight best practices to identify improvement opportunities.
2. Partner With Experienced Providers: Choose manufacturing execution system vendors with proven validation methodologies and comprehensive documentation.
3. Implement Risk-Based Assessment Tools: Consider solutions like the Validation Excellence Tool that formalize risk assessment and streamline validation documentation.
4. Train Your Team: Ensure your quality and validation teams understand modern, risk-based approaches to validation.

Want to see how leading companies are validating their systems in record time? Download our comprehensive industry brief for detailed implementation strategies.

The Future of Validation

The life sciences industry is moving toward even more streamlined approaches in the digital era, including self-validating software that can validate at the click of a button. These innovations will further reduce the burden of validation without jeopardizing regulatory compliance.

As manufacturing becomes increasingly digitized, efficient validation processes will be a key competitive advantage for life sciences companies. Organizations that master these approaches will be better positioned to implement advanced manufacturing execution systems that drive quality improvements, cost reductions, and accelerated time to market.

Conclusion

Software validation doesn't need to be the bottleneck that delays implementation of your manufacturing execution system. By adopting a risk-based approach, leveraging supplier documentation, focusing on critical business processes, and utilizing modern tools like the Validation Excellence Tool, life sciences companies can dramatically reduce validation times while maintaining compliance with regulatory requirements.

In today's ultra-competitive market, the ability to quickly deploy and update manufacturing execution software can provide a significant competitive advantage. Companies that master efficient validation processes will be better positioned to leverage technology for operational excellence and accelerated product delivery.

Ready to transform your validation approach? Download our industry brief on compliant and quick software validation to learn how leading companies are validating their systems in record time.

As the life sciences industry continues to evolve, those who embrace modern validation methodologies will lead the way in bringing life-changing products to market faster and more efficiently than ever before.

References:

1. “Pharmaceutical CGMPs for the 21st Century – A Risk-Based Approach,” Final Report, U.S. FDA, Sept. 2004.
2. “GAMP 5 Guide 2nd Edition,” ISPE.
3. “General Principles of Software Validation; Final Guidance for Industry and FDA Staff,” U.S. FDA, Jan. 11, 2002.