Cleaning is a critical process and must be validated. Documented evidence of a validated cleaning process should provide a high degree of assurance that a procedure deployed consistently, cleans to a predetermined, acceptable level. These requirements have been traditionally managed manually using paper-based systems. Unfortunately, such manual and paper-based processes can pose many challenges:

  • Paper-based documentation of cleaning validation and execution of protocols are prone to errors, and the time required for correction of these errors causes delays
  • The paper-based process can be inefficient and can lead to information “silos” within organizations that can hinder the integration of data and information generated over the product and process life cycle
  • Availability and visibility of cleaning data can be sub optimal and hinder verification of the cleaning validation statuses of equipment
  • Related calculations, such as MACO & ADE/PDE and worst-case identification, are generally carried out in spreadsheets, which may not be easily accessed and have challenging to verify audit trails, increasing the likelihood of compromised data integrity
  • Knowledge management can be hindered as knowledge tends to reside with only one person/group, leading to an organizational dependency on personnel instead of processes

Automated Cleaning Validation Lifecycle with ValGenesis VLMS

The ValGenesis VLMS integrates cleaning validation with process validation and equipment qualification. Additionally, lab instruments and equipment can be easily integrated to provide real-time capturing of sample test results from laboratory instruments and cleaning process parameters from equipment into the cleaning validation protocols. Cleaning log/batch records do not require manual data entry, ensuring compliance with 21 CFR Part 11, Annex 11, and Data Integrity standards.

  • Cleaning validation Master Plan created and approved in ValGenesis drives all stages of the cleaning validation process for products and equipment
  • Helps to determine and conduct the design and development of cleaning validation requirements, such as solubility, coupon, sampling, and dirty hold time studies
  • ValGenesis enables risk assessment at the equipment, drug product, cleaning process, and cleaning procedure levels
  • Optionally, dynamically creates the Process Equipment Train (PET) and Equipment grouping using product, equipment, and manufacturing master data with a complete audit trail that complies with regulatory requirements
  • Automatically calculates the risk score for a product and identifies the worst-case molecule based on a customer-defined risk assessment process
  • Automatically calculates the MACO value and residual limits for the worst-case molecule in comparison with the non-worst-case molecules and proposes final residual limit to be maintained in the SOP
  • Cleaning validation is driven by the Cleaning Validation Master Plan using application tools such as decision trees, risk assessment, frameworks, templates, and matrices
  • All validation deliverables are electronically created, reviewed, and approved, eliminating paper from the validation process and providing real-time validation status information
  • Electronic execution of cleaning batch record/log as part of the continuous monitoring process helps to monitor the cleaning process in real-time
  • Automatically perform trend analysis as part of annual product quality reports

Cleaning Validation

Advantages of Digitizing the Cleaning Validation Process:

ValGenesis VLMS enables total visibility across multiple sites, for critical data during the cleaning validation life cycle.

  • Reduced cleaning validation cycle time and cost by over 50%
  • Improved evidential consistency and standardization
  • Elimination of non-value-added activities
  • Increased levels of compliance with regulatory and data integrity requirements
  • More accurate tracking of changes and approvals
  • Real-time access to cleaning validation status
  • 100% electronic approach to cleaning validation life cycle in compliance to 21 CFR Part 11 and Data Integrity standards
  • Automates the cleaning validation life cycle by integrating all stages of cleaning validation, from design and development to validation and continuous monitoring
  • Electronic Cleaning Log/Batch Record with integration to lab instruments and equipment, directly capturing and recording sample results and process details

Resources

Videos

Efficient, paperless CSV
WATCH VIDEO

Press Releases

Leading Global R&D-Based Pharmaceutical Company Chooses ValGenesis’s VLMS to Manage Validation Process
LEARN MORE

Blogs

Cleaning Validation Requirements for the Life Science Industry
LEARN MORE