How to Reduce Costs in Computer and Software Validation · How to Reduce Costs in Computer and...

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


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


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


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


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?


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


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


Cost Factor Impacting CSV 9


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


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


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


Risk with Document Management Systems

• Compliance Risk

• Failure to follow approved procedures

• Lack of consistency

• Documentation issues

• Lost and misplaced records

• Regulatory observations


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)


San Diego CA

April 26 2017

ValGenesis, Inc.

Fremont | Tampa | Chennai

CA | FL | IND


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



• 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



• 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


• Background

• Problem Statement & Business Drivers

• Pre-Implementation Strategies

• Reducing Risk During Implementation

• Results & Benefits

• Lessons Learned

Case Study: Agenda


• 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


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


• 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


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


Multiple Locations roll out – some key considerations

• Location-specific tasks

• Procedure and Training alignment

• Management of future system updates

• License management



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



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


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


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


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


San Diego CA

April 26 2017

ValGenesis, Inc.

Fremont | Tampa | Chennai

CA | FL | IND


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


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



• Installation & Functional Verification forms

• Forms can be created by leveraging existing protocols

• Can be easily migrated to electronic test scripts!!!!!


Pre-Approved Verification Forms

• Implementation of verification forms

instead of protocols



• 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


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


Visual

Screenshot

N/A


Yes No ,


3 List the privileges to be

Added /Modified Deleted

___________________________________________________________________________________________________________________________________________________________________________


Meets Acceptance

Criteria

(Pass / Fail)

Verified By Initial / Date


Verification Forms (cont.)


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


Visual

Screenshot

N/A


Yes No ,


7 Log off from the User account. Successfully logged off from

the User account

Does Actual response meet the

Expected response?

Yes No


Visual

Screenshot

N/A


Yes No ,


Approved By Quality (Print/Sign):_____________________________ Date:______________

Completed by: Date:


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


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

Ph: 510 445 0505

Email: [email protected]

www.valgenesis.com

Thank You

mailto:[email protected]

http://www.valgenesis.com/

How to Reduce Costs in Computer and Software Validation · How to Reduce Costs in Computer and...

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