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Cleaning Validation Software That Accelerates GMP Compliance

Meet regulatory requirements and validate process equipment faster.

If you're producing pharmaceuticals, vaccines, or other regulated products, an effective cleaning validation program is critical to your manufacturing process. Inadequate cleaning of contact surfaces, packaging, and equipment can contaminate products, leading to production delays, product waste, FDA 483 observations, and costly regulatory citations. 

To stay on the right side of regulators, you must scientifically demonstrate and document that your cleaning methods consistently remove residues below the established acceptance criteria. ValGenesis cleaning validation software can help you maintain an efficient, effective automated cleaning validation program that protects product integrity while removing the human error associated with paper-based methods. 

What Are the Challenges of Paper-based Cleaning Validation?

Most companies still rely on paper and manual processes to manage their cleaning validation requirements, but paper-based validation is rife with challenges.

  • No pre-approved cleaning validation master plan: “Winging it” when it comes to cleaning validation is a recipe for disaster. Even if you have a pre-approved validation plan or strategy in place, documenting and managing it on paper leaves you vulnerable to human error and increased risk. In addition, the time required to correct mistakes or recreate lost documents and SOPs can lead to costly time-to-market delays.
  • Lack of transparency: Paper-based cleaning processes are inefficient and often lead to the compartmentalization or siloing of information within departments or with individuals. Paper records are inconveniently archived in an on-site repository or off-site facility. Relying on paper and manual methods deprives you of a unified, real-time view of your cleaning validation lifecycle activities.
  • Inconsistent outputs: Consistency is critical in cleaning validation but virtually impossible to achieve without an automated cleaning validation program. In a paper-based system, tasks are approached and documented in many ways; there is no standardization. This leads to inconsistencies in the calculation of surface area matrices, MACO calculations, worst-product and worst-case equipment identification, and other outputs.
  • Time-consuming cleanability impact assessments: Change is constant in cleaning validation, and every time you introduce a new product, piece of equipment, or change in cleaning procedure or formulation, you are required to assess the impact of the change. These assessments are time consuming and complex when performed manually.
  • Poor audit trails: Related calculations, such as maximum safe surface residue (MSSR) and health-based exposure limits (HBEL), as well as worst-case identification, are generally carried out in Excel spreadsheets, which may be challenging to access during audits and inspections. Limited access to vital records and documents can compromise data integrity and increase compliance risk.
  • Vague analytical methods: Analytical method validation defines the method parameters needed to provide confidence in your cleaning results. In a paper-based system, it’s hard to ensure your analytical methods are quantifiable when establishing your acceptance criteria. Frequently, the R&D team developing the method lacks visibility into how calculations are set.

 

 

Cleaning Validation of lab equipment

Cleaning Validation Resources

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Tip Sheet

Five Common Questions Answered about Cleaning Validation

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Digitization of Cleaning Validation Life Cycle

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The Benefits of Digitizing Cleaning Validation

A totally digitized cleaning validation solution is possible with the ValGenesis Validation Lifecycle Management System (VLMS), a cloud-based platform designed to address and simplify all areas of a life sciences company's complex validation needs—including process validation, equipment and instruments validation, and more. With the ValGenesis VLMS maintaining your organization's cleaning validation processes, you'll experience significant benefits:

End-to-end cleaning validation management: ValGenesis cleaning validation software automates the entire cleaning validation lifecycle by integrating all stages of cleaning validation, from design and development to validation to continuous monitoring. It replicates your current cleaning validation process while replacing the human error and inefficiency implicit in paper-based methods with improved consistency and reliability. There is no need to reconfigure your existing approach to reap the benefits of digitization.

Consistent outputs: Our VLMS automates key stage one activities, including analytical method development and the creation of the cleaning validation master plan, with technical controls, offering you a consistent way to perform cleaning validation lifecycle activities. You can create business rules based on your SOPs and requirements to ensure consistent output, including product family, equipment grouping, dirty and clean hold times, product assessment, and more.

Increased regulatory compliance: Our automated cleaning validation solution dynamically creates the process equipment train (PET) and equipment grouping using the product, equipment, and manufacturing master data creating a complete audit trail that complies with regulatory requirements. Information that is mandatory for international regulatory bodies will be denoted as compulsory in the system, and you can configure additional data entry fields based on your specific needs.

Risk-based approach: With ValGenesis, you can perform risk assessments at the equipment, drug product, cleaning process, and cleaning procedure levels. The solution automatically calculates the risk score for a product and identifies the worst-case molecule based on a customer-defined risk assessment process.

Streamlined cleanability impact assessments: Digitizing with ValGenesis allows you to perform the cleanability impact assessment through a one-time framework setup that automatically walks you through every required consideration. Streamlining this process saves you time and lets you know what to do to make, approve, and implement the change.

Rooted in scientific evidence: One of the biggest pain points in cleaning validation is ensuring that your methods and procedures are rooted in scientific evidence. Limit of detection (LOD) and limit of quantitation (LOQ) values are fully integrated into our cleaning validation software. The system flags out-of-limit values as not analytically supported.

Cleaning Validation digitization

Improve Your Cleaning Validation Methods with these Unique Features

Many life sciences companies are beginning to realize the cost and time savings of digitizing their cleaning validation efforts with ValGenesis' feature-rich automated cleaning validation solution. Features include:

  • Validation master plan driven by application tools such as decision trees, frameworks, templates, and dynamic trace matrices  
  • Electronic execution of cleaning log/batch records
  • Automatic creation of process equipment train (PET) and equipment grouping  
  • Automatic trend analysis as part of annual product quality reports  
  • Automatic calculation of maximum allowable carryover (MACO), total equipment contact surface area, and residual limits for worst-case vs. non-worst-case products  
  • Integrated close-looped cleaning validation lifecycle management with change control  
  • Electronic protocol execution  
  • 21 CFR Part 11-compliant features like time-stamped audit trails, reporting, and electronic signature capabilities
  • Aligns with ICH-Q principles for managing risk 

Ready to join the digital validation revolution?

Be confident your products meet regulatory, quality, and safety standards with our 100% paperless cleaning validation solution.

"We reduced cycle time more than 50% and gained data integrity in our validation process."

"Validation-related observations dropped 90% after implementation."

"We can easily manage validation deliverables and change requests across global sites with full data integrity."

Fill out the form to request a demonstration of ValGenesis VLMS.