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

1. Managing Cleaning Validation & Assessments
Sans Paper - A Case Study
Presented By
Jim McElroy
jim.mcelroy@novartis.com
Nagesh Nama
nagesh.nama@valimation.com
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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. 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. Solution:
Create a cleaning validation software tool

5. Control, Comply
Collaborate, eliminate paper,
increase productivity and simplify
cleaning assessment and
validation with
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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. 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. CAVA Features
Tasks/calendars, blogs, wikis, e- Repositories to manage Products, APIs,
mail integration. Solvents, Cleaning Agents, Cleaning
Procedures, Equipment and Analytical
Methods.
Collaboration
Entity
Management
Flexible workflow CAVA Cleaning
feature Workflows Assessment tool for
Cleaning Assessment and Cleaning new product, new
Verification Application
Validation equipment or
Assessment modification to
existing equipment
Executions
Cleaning
Validation
Web based paperless executions. Protocol Protocol forms for API Residue
Analysis form report for each Verification, Cleaning Agent
protocol type to perform Residue Verification and Microbial
executions. Verification.
Audit Trail and electronic signature
features compliant with 21 CFR
Part 11.

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. 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. 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. 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. 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. 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. Flowchart for Paper Based Cleaning Validation

16. Flowchart for Cleaning Validation using CAVA

17. Summary
CAVA provides an easy to navigate tool for performing
cleaning 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