How to Reduce Costs in Computer and
Software Validation
IVT Computer Validation Conference
San Diego CA
April 26 2017
ValGenesis, Inc.
Fremont | Tampa | ChennaiCA | FL | IND
Proprietary and Confidential
Agenda
• Challenges with traditional computer system validation Computer validation biggest challenges
Challenges related to electronic document management
systems
Challenges related to having inefficient validation processes
Areas that impact cost and efficiency
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Agenda (cont.)
• Cost effective streamlined CSV strategies Real life examples that can be easily implemented at your
facility
How to create and manage pre-approved CSV test scripts
Benefits of implementing an efficient approach for managing
computer system validation
Case Study: CSV Cost Reduction
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Challenges with Traditional CSV
• Failure to implement a risk based approach
• Excessive amount of waste• Delays during review & approval cycle
• Excessive amount of handoffs
• Duplication
• Rework
• Poor understanding of regulatory requirements
• Very poor understanding of data integrity requirements
• Unqualified resources assigned to support technical
projects
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Challenges with Traditional CSV (cont.)
• Overly conservative quality unit
• Inadequate cycle times
• Extremely inefficient process
• Cost is not well understood, managed and controlled
• Lack of data integration
• Lack of adequate accessibility to validation data and
information
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Cost Factors Impacting CSV
• Do you know the factors impacting cost?
• Are you managing those cost factors?
• Are you controlling those cost factors?
• Do you know the ENTIRE annual cost of your CSV
program?
• Do you know which areas are driving cost higher every
year?
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Cost Factors Impacting CSV (cont.)
• Unnecessary bureaucracy
• Excessive amount of reviewers and approvers
• Failure to implement a risk based approach
• Inadequate and inefficient change control process
• Duplication of activities between corporate & sites
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Cost Factors Impacting CSV (cont.)
• Bigger protocols = higher quality!!!!
• Inefficient and inadequate document control processes
• Overly conservative document control procedures
• Creating a protocol for all validation activities
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Cost Factor Impacting CSV 9
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Challenges with Paper-Based Validation• Compliance Risk
• Failure to follow approved procedures
• Difficult to enforce the approved validation procedures and validation
master plan
• Lack of consistency
• Difficult to standardize and harmonize the validation process across
sites
• Documentation issues
• Lost and misplaced records
• Regulatory observations
• Data integrity
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Challenges with Paper-Based Validation
• Business Risk
• Loss revenue
• Higher operational cost
• Higher expenses (document storage, archiving, retrieval,
resources)
• Inability to release manufacturing equipment
• Delayed production schedules
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Document Management Systems: The Solution?
• EDMS systems are inefficient due to the following
inefficiencies:
• Need to print protocols for execution
• Scanning documents back in the system
• Routing the executed document and related data for final
review
• Routing the executed document and related data for final
approval
• Initializing & dating every page and attachment
• Electronic document management systems normally
require a document control coordinator for each document
which adds additional cycle time, delays and cost
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Risk with Document Management Systems
• Compliance Risk
• Failure to follow approved procedures
• Lack of consistency
• Documentation issues
• Lost and misplaced records
• Regulatory observations
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Risk with Document Management Systems
• Business Risk
• Loss revenue
• Higher operational cost (document storage,
archiving, retrieval, resources, license cost)
• Inability to release manufacturing equipment
• Delayed production schedules
Cost Effective CSV strategies (Case Study)
IVT Computer Validation Conference
San Diego CA
April 26 2017
ValGenesis, Inc.
Fremont | Tampa | Chennai
CA | FL | IND
Proprietary and Confidential
Validation Lifecycle Management Systems
• Solutions that reduce cycle time by automating critical
validation activities
• Eliminates the non-value added manual activities that are
labor intensive and time consuming
• Web-based systems that manages the entire validation
lifecycle process including electronic execution
• Expedite the validation process and remove the
inefficiencies that plague paper-based validation processes
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Validation Lifecycle Management Systems
• Provides full visibility for GxP systems, reduces the
audit duration from a few days to hours:
• Improves efficiency
• Enhances consistency
• Reduces cycle time approximately 50%
• Enable cross-functional collaboration across multiple sites
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Validation Lifecycle Management Systems
• Provide the following integrated functions that
enable paperless lifecycle management:
• Requirements Management
• Dynamic Trace Matrices
• Risk Manager
• Validation Plan
• Protocol Developer
• Test Executor
• Off-line Execution
• Exception and Deviation Management
• Equipment Inventory
• Decommissioning/Retirement
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• Background
• Problem Statement & Business Drivers
• Pre-Implementation Strategies
• Reducing Risk During Implementation
• Results & Benefits
• Lessons Learned
Case Study: Agenda
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• Global Company
• Specializes in Medical Surgical Equipment & Instruments, Reconstructive and Neurotechnology & Spine
• Paperless Validation System Implementation:
• Implemented in US 2015 & Europe 2016
• More than 100 active users in the production instance
• More than 200 active users in the Development instance (Training)
• Planned roll out to more than 10 additional sites in 2017
Background
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Why Paperless? Some previous challenges
• Delays in completing validation projects - cycle time
• High costs with validating systems manually
• Innefficiencies in the validation process – inability to leverage documentation and personnel
• A high degree of manual effort for tracking, reporting, and audit preparation
• Risk of loss or damage to validation documentation
Problem Statement & Business Drivers
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• Streamlining some elements
• Stamping / Printing / Scanning and Costs
• Manual Approval and Execution
• Folders, Separators, Plastic Pockets etc.
• Archival and Retrieval
• Manual maintenance of system inventory
• Process for document numbering and metric generation
Problem Statement & Business Drivers
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Multiple locations roll out – some key considerations
• Senior management support
• Stakeholder inclusion in all locations – charter approval
• Robust Governance structure for the roll out program
• Robust organizational change management
• Super User training is a key requirement; ensure multiple users trained early
per location to keep continuity following org changes
• Is there the availability in each location to have a super user?
Pre-Implementation Strategies
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Multiple Locations roll out – some key considerations
• Location-specific tasks
• Procedure and Training alignment
• Management of future system updates
• License management
Pre-Implementation Strategies
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Multiple Locations roll out – additional considerations
• Vision and common organizational goals
• System configuration agreed upfront
• Changes may be needed in some locations
• Robust communication plan
• agree frequency, format and levels of communication
• Timing and relevance of end user communication key to acceptance of the system
e.g. awareness day with targeted merchandising
• Assess and eliminate inefficiencies in current paper-based
process, may vary by location
Pre-Implementation Strategies
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Considerations:
• Agree baseline and targets for measurements of success
• Generally a long term effort with a high level of technical knowledge of
the system needed; ensure sufficient numbers of personnel
trained and available
• Ensure adequate project timelines
• Identify roles and responsibilities between vendor and your
company
• Maintain organizational commitment
• Reinforce the value proposition
Reducing Risk During Implementation
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Benefits realized based on 1 yr. data
• Time/cost benefits and cycle time reduction
• 2-3 hours/document saved in validation engineers time, ~1300 docs/yr = up
to 3900 hours saved
• Minor savings in reduced cost of paper, binders, etc.
• Significant reduction in document rework due to GDP issues
• Periodic review tracking
• Site registry maintenance
• Real time metrics
Results & Benefits
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Efficiencies
• One Instance with multiple locations/sites – shared configuration and site
specific metadata
• Training is standardized with access managed through user group privileges
• Personnel can support multiple locations with single access (user group
controlled)
• Users can view previous validations in other locations
• Reporting can be performed at local, regional and higher levels
• Increased Compliance
Results & Benefits
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Ensure…
• Full understanding of configuration and functionality by project team before
planning implementation phase
• Pilot phase started as early as possible in the process
• Template, document and decision tree configurations discussed and
reviewed by all locations with case studies carried out before final decision
• Expectations for resolution of issues encountered during implementation
are agreed in advance e.g. level of regression testing carried out and
expected timeframe
Lessons Learned
Cost Effective CSV strategies
IVT Computer Validation Conference
San Diego CA
April 26 2017
ValGenesis, Inc.
Fremont | Tampa | Chennai
CA | FL | IND
Proprietary and Confidential
Document Approvers
• Typical approval cycle is more than five
validation documents approvers
• Lean approach for document approvers
should be two
• Lean Approach: Two document approvers• System Owner
• Quality
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Pre-Approved Verification Forms
• Implementation of verification forms
instead of protocols
• Lifecycle driven by SOP
• Forms are pre-approved
• Installation & Functional
Verification forms
• Forms can be created by
leveraging existing protocols
• Can be easily migrated to
electronic test scripts!!!!!
• Implementation of verification forms instead of protocols
• Lifecycle driven by SOP
• Forms are pre-approved
• Installation & Functional Verification forms
• Forms can be created by leveraging existing protocols
• Can be easily migrated to electronic test scripts!!!!!
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Pre-Approved Verification Forms
• Implementation of verification forms
instead of protocols
• Lifecycle driven by SOP
• Forms are pre-approved
• Installation & Functional
Verification forms
• Forms can be created by
leveraging existing protocols
• Can be easily migrated to
electronic test scripts!!!!!
• Forms can be created from requirements and design documents
• Forms can be used for the validation of changes to existing systems
• Examples of verification forms• Security verification
• Recipe verification
• Audit trail verification
• Parameter verification
• P&ID verification
• Loop check verification
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Verification Forms (cont.)
System Number: CC # (s) / WO #(s):
System(s) Description: Requirements document:
User Rights Verification
Step Action Expected Response Actual Response
Meets Acceptance
Criteria
(Pass / Fail)
Verified By Initial / Date
1 Login with Administrator account into the application.
Successfully logged into the Administrator account
Does Actual response meet the Expected response?
Yes No
Verification Criteria:
Visual
Screenshot
N/A
Screen shot Attached:
Yes No ,
Attachment #: ______
2
Document the user group to be modified.
___________________
___________________
Appropriate user groups are identified
Privileges are documented
Does Actual response meet the Expected response?
Yes No
Verification Criteria:
Visual
Screenshot
N/A
Screen shot Attached:
Yes No ,
Attachment #: ______
3 List the privileges to be
Added /Modified Deleted
___________________________________________________________________________________________________________________________________________________________________________
Step Action Expected Response Actual Response
Meets Acceptance
Criteria
(Pass / Fail)
Verified By Initial / Date
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Verification Forms (cont.)
Step Action Expected Response Actual Response
Meets
Acceptance
Criteria
(Pass / Fail)
Verified By Initial
/ Date
Make Copies As Needed
Privilege: _________________
Test Procedure:
_________________________
_________________________
_________________________
_________________________
_________________________
_________________________
_________________________
_______________
Privileges specified in step#
3 are successfully verified
Does Actual response meet the
Expected response?
Yes No
Verification Criteria:
Visual
Screenshot
N/A
Screen shot Attached:
Yes No ,
Attachment #: ______
7 Log off from the User account. Successfully logged off from
the User account
Does Actual response meet the
Expected response?
Yes No
Verification Criteria:
Visual
Screenshot
N/A
Screen shot Attached:
Yes No ,
Attachment #: ______
Approved By Quality (Print/Sign):_____________________________ Date:______________
Completed by: Date:
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Change Control • Simplifying Change Control
• Reducing change record reverts & rejects• Simplify rejection & revert criteria
• Risk based approach
• Change mis-classifications • Proper classification of changes based on risk
• Redefining classifications
• Not driving classifications based on validation impact
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Change Control
• Simplifying Change Control• Reduced number of assessors based on change impact
• Technical SME
• System Owner
• Validation
• Quality
• Unnecessary gates that don’t allow parallel task execution
• Break gates and allow parallel activities
• Combine task in Trackwise for parallel execution