Risk-Based Assurance in Pharma Manufacturing: Balancing Compliance and Operational Efficiency in MES

In today's pharmaceutical manufacturing landscape, companies face a critical challenge: maintaining strict regulatory compliance while improving operational efficiency. Manufacturing execution systems (MES) sit at the heart of this tension, requiring extensive validation that often leads to costly delays and operational disruptions. But what if there was a better way?

The Validation Burden in Modern Pharma Manufacturing

Traditional computer software validation (CSV) approaches have become increasingly burdensome as systems grow more complex. According to a recent BioPhorum report, manufacturers cite "excessive documentation requirements" and "lengthy validation cycles" as major challenges, with validation activities contributing substantially to implementation delays, inability to accept product updates and patches, and operational disruptions.

The administrative burden of validation can be overwhelming—extensive protocols, test scripts, and documentation requirements consume significant resources and expertise. In biologics manufacturing environments, where systems are particularly complex, this challenge is especially acute as validation activities can extend project timelines by months or even years. This results in manufacturers often missing out on the latest patches and enhancements that are available through the vendor – items that would enhance workflows, expand capabilities, and improve end user experience.

Revolutionary validation approaches await. Ready to cut months of validation time down to minutes? Our guide "8 Tips for Compliant and Quick Software Validation" shows you exactly how to maintain compliance without the operational disruptions. Download it today and join manufacturers who've already transformed their validation processes.

The CSV to CSA Transition: A Modern Approach

The industry is now embracing a major transformation as it shifts from traditional CSV to the more risk-based computer software assurance (CSA) recommendations provided in the recently finalized U.S. Food and Drug Administration (FDA) Computer Software Assurance for Production and Quality System Software guidance.² This risk-based approach fundamentally changes how we think about validation, focusing efforts where they matter most rather than treating all system elements with equal scrutiny.

As I noted in the recent BioPhorum paper, "MANUFACTURING EXECUTION SYSTEMS (MES): Industry challenges and enablers," streamlined validation processes and risk-based assurance are no longer just aspirational. MasterControl supports the paper's blueprint to modernize lifecycle management and validation, to ensure upgrades are safer, faster, and less costly, without compromising compliance or audit readiness. We are fortunate today to have processes and solutions to support more advanced tools to enable organizations to reduce this burden.

The Principles of Risk-Based Validation for MES

At its core, risk-based validation recognizes that not all system functionalities carry the same level of risk to product quality and patient safety. Manufacturers can ensure they are maintaining their validation compliance by applying a tiered approach:

1. Risk Assessment: Evaluate each MES function based on its intended usage and impact on product quality, patient safety, and data integrity.
2. Right-Sized Testing: Apply more rigorous testing to high-risk functions while streamlining validation for lower-risk elements.
3. Continuous Assurance: Move from periodic revalidation to continuous monitoring and incremental validation.

This approach allows manufacturers to achieve the same—or better—compliance outcomes while significantly reducing the validation burden.

Focus where it matters. Validate with confidence.

MasterControl's patented Validation Excellence Tool (VxT) puts these risk-based principles into action, helping you target validation efforts precisely where they impact patient safety and product quality. Discover how in our complimentary validation guide that's already helping life sciences companies slash validation time while enhancing compliance.

Modernized MES Validation in Practice

When looking at what modernized MES validation looks like in practice, three key elements emerge:

1. Automated Validation Tools

To streamline processes, modern validation practices leverage automation such as:

• Auto-generated test protocols based on historical batch data.
• Automated execution of validation scripts.
• Continuous integrity checking rather than point-in-time validation.

Modern tools also allow for automated validation of fully customizable workflows. Previously any customization or variation from vendor provided out of the box workflows, would require all manual validation. This a problem of the past with tools like MasterControl's Validation on Demand (VoD). You can learn more about MasterControl's approach to validation and the unique VoD offering in this blog post.

Validation in less than 10 minutes, not months. That changes everything. MasterControl customers have transformed their upgrade cycles from multi-month marathons to sprints of just a few minutes. Get our industry brief to see how our digital validation methodology can revolutionize your MES processes—because when validation isn't a burden, innovation thrives.

2. Vendor-Supplied Validation Packages

The BioPhorum report emphasizes "leveraging vendor-provided validation packages for systems and automated testing frameworks" to significantly streamline compliance efforts. By accepting out-of-the-box systems and relying on supply-partner-provided validation materials, organizations can reduce resource-heavy in-house validation.

3. Modular Validation Approaches

Modern, modular MES architectures enable targeted validation of specific components like:

• Validating only updates to the validated state rather than the entire system, based on risk.
• Implementing blue/green deployment strategies that allow seamless switching between validated environments. Having this capability for configuration management across environments helps ensure there isn't drift for the validation efforts and that your validation testing is perfectly reflective of your production usage.
• Decoupling operations management functions to reduce interdependencies.

Balancing Compliance and Innovation

The traditional view that validation acts as an innovation barrier is outdated. Modernized lifecycle management approaches actually enable faster innovation while maintaining compliance, bringing benefits like:

• Accelerated Updates: With CSA approaches, updates that once took months can be deployed in days or weeks.
• Reduced Resistance: When validation is less burdensome, organizations become more willing to implement beneficial changes.
• Enhanced Compliance: By focusing validation efforts where they matter most, overall system quality and compliance can actually improve.

Implementing Modernized Lifecycle Management

There are five steps organizations looking to modernize their MES validation approach can take:

1. Evaluate Your Validation Strategy: Review current practices against CSA principles to identify opportunities for optimization.
2. Establish Risk Categories: Create clear definitions of high, medium, and low-risk system components and add commentary regarding your reasoning for making those assessments. Documenting the critical thinking you are doing to determine the risk and level of validation testing required is the most important part of CSA.
3. Update Procedures: Revise validation standard operating procedures (SOPs) to reflect risk-based approaches.
4. Build Quality by Design: Embed validation considerations into implementation planning rather than treating it as an afterthought.
5. Engage Stakeholders: Work closely with QA, IT, and operations to build consensus around modernized approaches.

Digitize validation. Accelerate innovation.

Join forward-thinking manufacturers who've embraced modern validation approaches. Download "8 Tips for Compliant and Quick Software Validation" and discover how MasterControl's risk-based methodology not only ensures compliance but actually becomes a competitive advantage. When validation enables innovation instead of hindering it—that changes everything.

A Competitive Advantage

Organizations that successfully implement risk-based validation approaches stand to gain significant advantages. As the BioPhorum report highlights, this approach can help "reduce time-to-value from years to months," creating a more responsive, user-focused MES environment.

The observation that modernized validation helps manufacturers realize value in months, not years reflects the transformative potential of this approach. By embracing CSA principles, organizations can maintain compliant MES while dramatically improving their operational efficiency and responsiveness.

The path forward is clear: modernized computer software validation through risk-based approaches isn't just a regulatory trend—it's a competitive necessity for manufacturers looking to balance compliance requirements with the need for operational excellence in an increasingly complex manufacturing environment.

As you evaluate your own validation strategies, consider how a modernized, risk-based approach could transform your MES implementation, maintenance, and upgrade processes, potentially saving months of time and millions in costs while maintaining the highest standards of compliance and product quality.

References:

1. "MANUFACTURING EXECUTION SYSTEMS (MES): Industry challenges and enablers," BioPhorum, Sept. 2025.
2. "Computer Software Assurance for Production and Quality System Software," Guidance for Industry and Food and Drug Administration Staff, FDA, Sept. 2025.