Novartis and ValiMation Present a SharePoint Solution for Risk Based Cleaning Validation


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Novartis and ValiMation Present a SharePoint Solution for Risk Based Cleaning Validation

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Novartis and ValiMation Present a SharePoint Solution for Risk Based Cleaning Validation

  1. 1. Managing Cleaning Validation & Assessments Sans Paper - A Case Study Presented By Jim McElroy Nagesh Nama nagesh.nama@valimation.com1
  2. 2. Types of Cleaning Validation Documents Cleaning Procedure Cleaning Validation Assessment (CVA) Cleaning Validation Study (Lab notebook: eg. recovery study) Cleaning Verification Cleaning Validation Protocol (three episodes) Site Monitoring Program
  3. 3. Cleaning Validation is rules based Most companies maintain spreadsheets to collect and store data Require human resources to research and manage data Considerable time and energy is required to keep information current and useful Requires well-trained experts to manage the cleaning program effectively
  4. 4. Solution: Create a cleaning validation software tool
  5. 5. Control, Comply Collaborate, eliminate paper, increase productivity and simplify cleaning assessment and validation with5
  6. 6. Without CAVA Entity Management:  Information retrieval regarding the linking between different entities is complex.  Approval of the different entities required to perform a cleaning assessment is a time consuming process. Cleaning Validation Assessments:  Cleaning Assessments are paper based, inefficient and time consuming.  The calculations used for performing an assessment are manual calculations and hence can lead to human errors. Cleaning Validation Protocol:  Acceptance criteria for each protocol is calculated manually and can lead to human errors.  Cleaning validation protocol and report preparation is time consuming.  Lack of audit trails.
  7. 7. Without CAVA (continued) Executions:  Executions are completely paper based and inefficient.  Test script reviewers spend a lot of time enforcing good documentation practices.  Even summary report generation takes time since it is done manually. Workflow:  Workflow automation for entity, cleaning assessment and protocol management is highly inflexible or non existent. Collaboration:  A collaboration workspace linked to validation life-cycle entities is non-existent  A Validation Lifecycle Management system built on industry’s #1 collaboration platform (Microsoft SharePoint) is not present
  8. 8. CAVA FeaturesTasks/calendars, blogs, wikis, e- Repositories to manage Products, APIs,mail integration. Solvents, Cleaning Agents, Cleaning Procedures, Equipment and Analytical Methods. Collaboration Entity ManagementFlexible workflow CAVA Cleaningfeature Workflows Assessment tool for Cleaning Assessment and Cleaning new product, new Verification Application Validation equipment or Assessment modification to existing equipment Executions Cleaning ValidationWeb based paperless executions. Protocol Protocol forms for API ResidueAnalysis form report for each Verification, Cleaning Agentprotocol type to perform Residue Verification and Microbialexecutions. Verification.Audit Trail and electronic signaturefeatures compliant with 21 CFRPart 11.
  9. 9. Entity Management Features:  The CAVA application provides repositories to manage information for products, APIs, solvents, cleaning agents, equipment, cleaning procedures and analytical methods.  The entities mentioned above can be created, edited, approved and retired.  Rules have been defined to link an entity to other entities (eg: 1) a product is linked to an equipment, API 2) a cleaning agent is linked to a cleaning procedure etc..) Benefits:  Rules defined to link different entities makes it easy to search and retrieve information from the entity repositories.  KPI dashboards for real-time data
  10. 10. Cleaning Validation Assessment Features:  Cleaning assessment tool for a new product, new equipment or modification to existing equipment.  Rules have been established to ensure only entities that have been approved are used for performing an assessment.  Ability for the user to override the recommendation and action item provided by the tool. Benefits:  Elimination of manual calculations involved in performing an assessment leads to the elimination of human errors.  Web based assessment tool improves efficiency and reduces cost.
  11. 11. Cleaning Validation Protocols Features:  Web/Form based paperless protocols for API residue verification, cleaning agent residue verification and microbial verification  Formulas in place to calculate the acceptance criteria for each protocol type based on the cleaning assessment data Benefits:  Dependency of protocols on approved cleaning assessments eliminates the process of re- entering data in the protocols  Calculation of the acceptance criteria by the system eliminates human error  Paperless protocol preparation improves efficiency and reduces cost
  12. 12. Executions Features:  Paperless execution mode using web based forms for each protocol type  Formulas in place to determine the result (pass/fail) for every executed step  Audit trail and electronic signature features compliant with 21 CFR Part 11  Real-time execution KPIs Benefits:  Significant reduction in execution time  Increased data accuracy  Reviewers can focus on data rather than enforcing mundane good documentation practices
  13. 13. Workflow Features:  Workflow features are highly configurable and flexible  Multiple workflow types can be deployed on a single repository. Benefits:  Workflow features can be configured and deployed by business users  Workflows improve efficiency and reduce cost
  14. 14. Collaboration Features:  SharePoint features: Collaborative workspaces and social computing tools Wikis, blogs, and team discussion boards Benefits:  Empower teams to work together and collaborate more effectively  Enable communities and connect people, teams, and expertise  Enable ad-hoc information sharing  Support for business process integration
  15. 15. Flowchart for Paper Based Cleaning Validation
  16. 16. Flowchart for Cleaning Validation using CAVA
  17. 17. SummaryCAVA provides an easy to navigate tool for performingcleaning assessment and validation and helps eliminate paper,increase productivity and simplify cleaning validation Comply Control Implement cleaning Increase your compliance assessment and validation while reducing cost processes that are effective and sans paper