How to Reduce Costs in Computer and Software Validation

Transcription

1 How to Reduce Costs in Computer and Software Validation IVT Computer Validation Conference San Diego CA April ValGenesis, Inc. Fremont Tampa Chennai CA FL IND

2 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

3 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

4 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

5 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

6 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?

7 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

8 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

9 Cost Factor Impacting CSV

10 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

11 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

12 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 Proprietary and Confidential

13 Risk with Document Management Systems Compliance Risk Failure to follow approved procedures Lack of consistency Documentation issues Lost and misplaced records Regulatory observations

14 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

15 Cost Effective CSV strategies (Case Study) IVT Computer Validation Conference San Diego CA April ValGenesis, Inc. Fremont Tampa Chennai CA FL IND

16 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 Proprietary and Confidential

17 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 Proprietary and Confidential

18 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 Proprietary and Confidential

19 Background Case Study: Agenda Problem Statement & Business Drivers Pre-Implementation Strategies Reducing Risk During Implementation Results & Benefits Lessons Learned

20 Background 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 Proprietary and Confidential

21 Problem Statement & Business Drivers 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

22 Problem Statement & Business Drivers 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

23 Pre-Implementation Strategies 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?

24 Pre-Implementation Strategies Multiple Locations roll out some key considerations Location-specific tasks Procedure and Training alignment Management of future system updates License management

25 Pre-Implementation Strategies 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

26 Reducing Risk During Implementation 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

27 Results & Benefits 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

28 Results & Benefits 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

29 Lessons Learned 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

30 Cost Effective CSV strategies IVT Computer Validation Conference San Diego CA April ValGenesis, Inc. Fremont Tampa Chennai CA FL IND

31 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 Proprietary and Confidential

32 Pre-Approved Verification Forms Implementation of verification forms instead of Implementation protocols of verification forms instead of protocols Lifecycle driven by SOP Lifecycle driven by SOP Forms are pre-approved Installation & Functional Verification forms Forms are pre-approved Forms can be created by leveraging existing protocols Installation & Functional Verification forms Can be easily migrated to electronic test scripts!!!!! Forms can be created by leveraging existing protocols Can be easily migrated to electronic test scripts!!!!!

33 Pre-Approved Verification Forms Implementation of verification forms documents instead of protocols Forms can be created from requirements and design Forms can be used for the validation of changes to existing systems Lifecycle driven by SOP Forms are pre-approved Examples of verification forms Security verification Installation & Functional Verification forms Recipe verification Audit trail verification Parameter verification Forms can be created by leveraging existing protocols P&ID verification Loop check verification Can be easily migrated to electronic test scripts!!!!!

34 Verification Forms (cont.) System Number: CC # (s) / WO #(s): System(s) Description: User Rights Verification Requirements document: Step Action Expected Response Actual Response 1 Login with Administrator account into the application. 2 Document the user group to be modified. 3 List the privileges to be Added /Modified Deleted Successfully logged into the Administrator account 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 #: Does Actual response meet the Expected response? Yes No Verification Criteria: Visual Screenshot N/A Screen shot Attached: Yes No, Attachment #: Meets Acceptance Criteria (Pass / Fail) Verified By Initial / Date Step Action Expected Response Actual Response Meets Acceptance Criteria (Pass / Fail) Verified By Initial / Date

35 Verification Forms (cont.) Step Action Expected Response Actual Response Privilege: Test Procedure: Privileges specified in step# 3 are successfully verified Make Copies As Needed Does Actual response meet the Expected response? Yes No Verification Criteria: Visual Screenshot N/A Screen shot Attached: Yes No, Meets Acceptance Criteria (Pass / Fail) Verified By Initial / Date 7 Log off from the User account. Successfully logged off from the User account Attachment #: Does Actual response meet the Expected response? Yes No Completed by: Verification Criteria: Visual Screenshot N/A Screen shot Attached: Yes No, Attachment #: Date: Approved By Quality (Print/Sign): Date:

36 Change Control Simplifying Change Control Reducing change record reverts & rejects Simplify rejection & revert criteria Risk based approach Proprietary and Confidential Change mis-classifications Proper classification of changes based on risk Redefining classifications Not driving classifications based on validation impact

37 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

38 Thank You Ph: