Is Your Cleaning Validation Stuck in the Slow Lane?

Despite being a long-standing requirement in regulated manufacturing, cleaning validation continues to challenge even the most mature organizations. Manual workflows, disconnected data, and reactive documentation make it difficult to consistently meet rigorous cleaning validation requirements in today’s increasingly complex manufacturing landscape. 

In many cases, outdated processes limit productivity, delay batch start, and increase the risk of inspection findings. At the same time, regulators are raising the bar—treating cleaning validation as a continuous lifecycle activity, not a one-time event. As expectations evolve, especially for cleaning validation in GMP environments, teams are under pressure to modernize how they approach compliance, quality, and risk. 

This blog post explores what cleaning validation is in pharma, why cleaning validation is required, and how modern digital platforms can help you meet compliance requirements while driving measurable gains in efficiency and control.

Is Cleaning Validation Slowing You Down?

In some pharmaceutical facilities—especially sterile-liquid and biologics operations—cleaning activities routinely consume 30% or more of planned production time, limiting output and driving overall equipment effectiveness (OEE) to barely a third of its potential. That lost time goes beyond idle lines—it delays approvals, consumes resources, complicates investigation and review cycles, and each rework cycle slows the path to starting the next batch. 

Top-performing sites face the same regulatory pressures, but they’ve taken a different approach. Rather than adding more headcount or investing in new physical assets, they’ve focused on modernizing how they plan, execute, and monitor cleaning validation. The result? OEE rates can climb to 90%, with cleaning-related downtime treated as a rare exception—not the norm. 

What separates these leaders isn’t the age of their facility or the cost of each piece of equipment. It’s the decision to move away from paper-heavy, error-prone manual workflows and adopt a digital framework that captures, connects, and confirms every step of the process.

What is Cleaning Validation in Pharma—and Why Is It Still a Challenge?

Understanding why cleaning validation is required is essential. In GxP environments, it is a regulatory mandate designed to prevent cross contamination in pharma and ensure patient safety. In the U.S., FDA cleaning validation guidelines, such as 21 CFR 211.67, require documented procedures for the cleaning and maintenance of equipment used to manufacture drug products (Code of Federal Regulations, 2023). European guidelines emphasize toxicology-based residue limits, replacing outdated numerical thresholds with scientifically justified criteria and risk assessment and understanding. 

These developments have elevated cleaning validation from a static compliance task to a dynamic, lifecycle discipline. However, as requirements increase, manual processes continue to create friction. Each cleaning agent, product, and surface changes the equation. Residue limits depend on a combination of potency, toxicity, dosage, and surface area—and proving control demands statistically confident methods and lifecycle monitoring. 

If your cleaning validation processes still rely on spreadsheets, binders, or isolated files, you're likely dealing with delays, deviations, increased inspection risk from hidden errors, and lost opportunities for deeper risk understanding in complex manufacturing environments.

The Hidden Costs of Paper-Based Cleaning Validation

• Time and labor inefficiencies: Creating, circulating, and approving strategies, assessments, protocols, and reports on paper consumes valuable cross-functional time, delays equipment release, and obstructs validation readiness. Each round of rework or clarification adds hours—or days—before cleaning can begin.
   
• Inconsistency and variability: Ad hoc spreadsheets and paper checklists allow too much room for interpretation. Operators may apply procedures differently, especially when cleaning processes lack consistent documentation, provide limited access to knowledge sources, are buried on dozens of pages of text and tables, or involve equipment that’s inherently difficult to clean. This variability is a key reason why cleaning validation deficiencies contributed to 42 FDA warning letters in 2022 (BioProcess International, 2023).
   
• Limited traceability: When data is scattered across binders, file shares, and uncontrolled folders, audit readiness becomes a scramble. Quality teams may spend hours tracking down the most recent version of a cleaning validation protocol or verifying execution records.
   
• Regulatory lag: As agencies refine expectations—particularly around toxicology-based acceptance limits and lifecycle-based cleaning validation requirements—teams must recalculate MACO values, revise SOPs, and often revalidate. When these updates depend on manual processes, each site’s response time slows to a crawl. 

How Digital Tools Accelerate Cleaning Validation

Modern cleaning validation software is designed to manage the growing scientific, regulatory, and operational complexity of today’s GMP expectations. Platforms like ValGenesis streamline critical validation tasks while improving consistency, traceability, and efficiency across global operations.

Key capabilities include:

• Automated MACO determination: The platform calculates Maximum Allowable Carryover based on defined toxicological parameters and equipment mappings. Inputs like product potency, shared surface areas, and cleaning agent compatibility are integrated to deliver defendable calculations—automatically aligned with your site’s SOPs and business rules.
  
  
• Visualized sampling plans: Using 2D and 3D imaging, the system identifies specific swab and rinse locations. This ensures consistent execution of sampling protocols, even across large, complex facilities or infrequently used equipment.
   
• Embedded cleaning logic: Business-rule-driven workflows flag conflicts and identify worst-case product and equipment pairings instantly. This eliminates reliance on tribal knowledge and reduces the risk of inconsistent bracketing decisions.
   
• Integrated change management: When new equipment is introduced or a process change occurs, the platform highlights impacted cleaning validation protocols, risk assessments, and validation plans. This ensures no downstream impact is overlooked.
   
• Audit-ready execution: Operators perform tasks using electronic logbooks with timestamped entries, QR code scanning, and guided instructions—ensuring ALCOA+ compliance without adding manual overhead (ValGenesis, 2024b).
   
• Lifecycle traceability and verification: The platform supports independent scheduling of requalification and cleaning validations, tailored to specific products, equipment, or cleaning procedures. Built-in dashboards and alerts help ensure nothing is missed. 

Digital validation tools like Process Manager can reduce cleaning-related downtime and support resources by up to 40% within the first year—while virtually eliminating repeat deviations (ValGenesis, 2024a). Just as important, they give teams the confidence that every cleaning event, record, and result is both verifiable and inspection-ready.

Automation of CIP workflows can reduce cleaning-related downtime by up to 40%. 

Your Roadmap to Modern Cleaning Validation

• Assess current performance: Begin by quantifying the impact of your existing cleaning validation practices. Track average cleaning downtime in hours per batch, frequency of deviations, and the time spent preparing for audits. Look at variation between shifts or facilities; it may reveal gaps caused by undocumented or inconsistently followed procedures.
   
• Map manual touchpoints: Identify where data changes hands or is entered manually: protocol drafting, risk assessments, swab result recording, deviation resolution. Every manual step introduces a delay and a potential compliance risk. Use this mapping to prioritize which areas need digitization first.
   
• Launch a pilot: Choose one product family or manufacturing line with frequent changeovers or known cleaning challenges. Focus your pilot on demonstrating value—shorter turnaround times, reduced rework, improved protocol clarity, or easier validation of difficult to clean assets.
   
• Document outcomes: Capture both qualitative and quantitative benefits. Highlight reductions in human error, stronger control over acceptance documentation, and faster closure of investigations. These results help secure buy-in from quality leadership and operational teams.
   
• Standardize and scale: Use lessons from your pilot to define reusable workflows and data structures. Harmonize how cleaning procedures are developed, executed, and approved across sites. A centralized data model ensures consistency while enabling local flexibility where needed. 

This roadmap not only sets the foundation for sustainable digital transformation but also strengthens your compliance posture, improves operational agility, and prepares your team for the evolving expectations of global regulators.

The Business Case for Digitalizing Cleaning Validation

• Higher throughput: By reducing cleaning-related downtime from 30% to below 10%, plants can unlock previously unproductive and revenue-impacting capacity. This efficiency gain can defer capital investments in new equipment or facility expansions, while improving agility in meeting fluctuating market demand.
   
• Faster tech transfers and launches:  A digital platform accelerates cleaning validation across Stage 1 and Stage 2 activities by standardizing templates, automating acceptance criteria, and ensuring that all validation tasks align with current product and process data. The result is faster facility readiness, smoother regulatory submissions, and reduced time to market.
   
• Cost control: Manual errors in calculations, missing signatures, and repeat validations add hidden costs to every batch. Digitalization reduces rework, overtime, and the burden on quality and engineering teams—lowering the cost of goods and freeing resources for strategic initiatives.
   
• Improved compliance: With built-in version control, audit trails, and role-based access, digital systems maintain compliance by design. They also make it easier to demonstrate validation controls during inspections—especially when dealing with high-potency compounds or multi-product facilities (ValGenesis, 2024b).
   
• Scalability across global operations: Cloud-based, configurable platforms provide a unified framework for validation while allowing site-level flexibility. Whether you're managing a single facility or a network of CMOs, you gain a consistent approach to cleaning validation requirements that scales with your business. 

When implemented thoughtfully, digital cleaning validation enables measurable performance improvements while building a stronger foundation for long-term regulatory success.

A digital cleaning validation system centralizes control—from MACO calculations to audit-ready protocols.

Modernize with Confidence

In today’s regulatory and manufacturing environment, cleaning validation must do more than meet baseline compliance. It must scale across product lines, sites, and systems—while delivering traceability, scientific justification, and ongoing verification. 

Paper-based cleaning validation methods may have served in the past, but they no longer meet the speed, consistency, or reliability required in modern pharma and biotech operations. As regulatory bodies continue to elevate expectations around lifecycle validation, data integrity, and risk-based decision-making, the limitations of paper-based systems become more pronounced—and more costly. 

By embracing intelligent digital tools, you gain more than efficiency. You create a framework for ongoing improvement: harmonized data structures, standardized procedures, and faster alignment with evolving global requirements and FDA cleaning validation guidelines. You reduce the friction that slows production and introduce the visibility needed to make proactive, confident decisions. 

Digitalizing cleaning validation doesn’t just reduce deviations—it empowers your team to operate with precision, speed, and resilience. In a world where product pipelines are accelerating, increasingly complex, and scrutiny is intensifying, digitalized control is more than a technical upgrade. It’s a competitive advantage.

References

BioProcess International. (2023). Cleaning validation: Increasingly under the regulatory spotlight. https://bioprocessintl.com/ 

Code of Federal Regulations. (2023). Title 21 CFR 211.67: Equipment cleaning and maintenance. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/section-211.67 

ValGenesis. (2024a). Five cleaning validation challenges digitalization solves. https://valgenesis.com/blog/five-cleaning-validation-challenges-digitalization-solves 

ValGenesis. (2024b). Avoiding common FDA 483 observations in cleaning validation. https://valgenesis.com/blog/avoiding-common-fda-483-observations-in-cleaning-validation