Transcript Presentation - ValGenesis Inc

ValGenesis
Enterprise Validation Lifecycle Management System
ValGenesis, Inc.
47102 Mission Falls Court, Fremont, CA 94539
Ph: 510.445.0505 : www.valgenesis.com
ValGenesis, Inc.
• Best-in-Class system for Validation Lifecycle Management Process
• Years of combined industry experience in pharmaceutical drug substance
and drug product manufacturing, quality, and information technology
• Pharmaceuticals, Biotech, Medical Device
• Global Regulated Life science companies - Bayer, Amgen, Roche, ………
• 100% Web-based system scalable from a single site deployment to a
multi-location global deployment
• PDA New Innovative Technology Award for providing an innovative
software platform
Current State of Corporate Validation Process
No Single View of the Quality Status and Validation Information
Peer
Review
Review
Approve
Execute
Difficult to Track
Inefficient Collaboration
Audits
Create
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?
Validation Manager
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Time consuming Audits
?
Islands
of data
Enterprise
?
?
Method
Validation
Instrument
Validation
Validation
Data
?
DMS
Equipment
Validation
LIMS
Process
Data
CSV
DMS
Validation
Protocol
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LIMS
Cleaning
Validation
Process
Validation
Process
Data
LIMS
Process
Data
LIMS
Process
Data
Validation Lifecycle and Change Management
After Implementing ValGenesis – Efficient Validation Process
Peer
Review
Holistic View
Review
Efficient Collaboration
Approve
Execute
Create
Audit
Successful Audits
Global
View
Enterprise
Central
Validation
Management
Instrument
Validation
Equipment
Validation
CSV
Process
Validation
Cleaning
Validation
Method
Validation
QMS
DMS
LIMS
ERP
MES
LMS
ValGenesis System Overview
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100% browser based system with zero footprint clients
Compliant with 21 CFR Part 11 and Annex11
Integrates with your LDAP or Active Directory
User and Role level security
Support
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Offline Data Entry Capability
eMail Notifications
Alerts & Escalations
Out of office delegation and Task Reassignment
Serial / Parallel / Combination Workflows
Web Service and API integration
PDF generation with watermarking
 Ad-hoc Report Writer
ValGenesis Validation System Platform
KPIs/ Metrics
KPI Dashboard
Ad hoc Query/Reporting
Validation
PM
Tools
Business Analytics
Framework
Dynamic
Trace Matrix
Risk Management
(FMEA and ASTM)
Protocol Execution
Management
Validation Project
Continuous Monitoring
Validation Status
Monitor/Control
Protocol/Content
Authoring
Change Management
Requirements
Management
Workflow Designer
Periodic Review
Management
Forms Designer
Flexible Designer
Process Flow Designer
Tracking and Reporting
Features
“We have…”
Document Pie Charts
Inventory Manager
Benefits
“It Will…”
Value
“Which Means…”
Improved management of
document deliverables
Find out the bottle necks process
Singular repository for document
deliverables, change controls, and
system validation status
Track validation of status in real time
Delivery on time
Holistic view of validation status
Always prepared for Audits
Ad Hoc Reporting
Any type of report can be
generated
Reports can be exported to MS
Office tools
Validation Calendar
Provides visibility to all the cross
functional groups about the
upcoming Periodic review of any
system site/corporate wide
Report on any data & document
Metrics reports
Granular and easily share reports
Minimizes the impact of periodic
review schedules on other regular
activities
Status of Documents under Development
Documents Under Development Pie Chart displays all
of the documents being developed. Each section of
the pie chart represents a different phase in the
development life cycle
Click on any pie chart section to view the
documents that are in the selected phase
Example of Process Flow Accessible through Pie Charts
When Val. Doc. No. or Val. Exe. No.
is clicked for list of documents being
developed, executed, reviewed, or
approved from Development and
Execution Pie Charts, the Process
Flow is displayed.
Process Flow indicates where the
document is and where it is going
next
Inventory Report in Dashboard
Categories
Sub Categories
Entities
Inventory Report provides a holistic view of the corporate validation status. Real time validation status or Audit trail
of any entity or documents can be found in few mouse clicks through this inventory report.
Example of Metrics Report for a User
Metrics reports for users will display all of the
tasks that have been completed by the user
Filtering options available to display tasks
completed over a given time frame
Validation Calendar –Revalidation Schedules
Delayed Schedule
Tasks displayed
in Red Font
Current Schedule
Tasks displayed
in Green Font
Future Schedule
Tasks displayed in
Blue Font
Upcoming Periodic Review and Revalidation schedules will be captured and displayed in the Validation
available in dashboard.
Frameworks and Projects
Features
“We have…”
Benefits
“It Will…”
Value
“Which Means…”
Validation Frameworks
Standardized document deliverable Consistency in validation
requirements that determine
Ensures that all key deliverables are
validation status of any system
Project Designer
Assign Project Managers to
manage validation throughout
project lifecycle
Set deliverables in phases to
enforce quality gate checks
Simplifies project management with
real time document tracking
Enforces document to document and
system to system dependencies
Real time document status updates
Controlled Approval
Workflows
Frameworks, projects, and project
summaries routed through
controlled user defined workflows
to enforce consistent validation
procedures
Consistent workflows
Enforce validation policies and
procedures derived from SOPs and
policy documents
Enforce Document Deliverable Requirements
Level of
Documentation
required is based
on the risk level
Enforce validation policies and procedures derived from SOPs
and policy documents
Document Authoring
Features
“We have…”
Benefits
“It Will…”
Value
“Which Means…”
Develop documents using Author, Review and Approve
MS Office tools
documents quickly using tools
already familiar with end users
Leverages existing infrastructure
Template driven
development
Develop from pre-approved
templates stored within a single
repository
Enforces document consistency
Test function
management
Define standard tests that can be
reused across several documents
Accelerates document authoring
through test functions
No need to learn new tool to manage
validation documents
Simplifies template management
through single repository
Enforces document consistency
Controlled workflows
User defined workflows to manage
review and approval of documents
Documents can be routed in
parallel to accelerate review and
approval
Documents routed electronically
Accelerates review and approval
Eliminates possibility of lost
documents
Simplifies management of documents
through controlled workflows
Dynamic Traceability Matrix
Features
“We have…”
Dynamic Trace Matrix
generation
Benefits
“It Will…”
Value
“Which Means…”
Trace matrices can be built in the
system in three easy steps
Ensures that requirements have been
tested thoroughly
System automatically links
requirements to tests
Provides forward and backward
traceability
Impacted requirements
automatically updated
Dynamic update to trace matrix to
illuminate any requirements that
may be impacted as a result of
testing failures
Easy to conduct regression testing
Controlled workflows
User defined workflows to manage
review and approval of trace
matrices
Accelerates review and approval
Requirement changes illustrated
directly on trace matrix
Simplifies management of
requirement changes
System provides ability to add,
modify, or delete requirements
Automatically updates impacted
traceability matrices
Requirements
management
Real time information related to
testing and requirements
Manages trace matrices like any other
validation deliverable
Dynamic Traceability
CQP and Verification
Test cases
Linked
Easily through
Checkboxes
CQPs are living data and
linked with other data
sources.
Passed Tests
Highlighted in Green
Unexecuted Rows
Highlighted in
Orange
Failed Test Cases
Highlighted in Red
Good Engineering Practice (GEP) should underpin and support the specification, design, and verification activities.
Electronic Execution and Deviation Management
Features
“We have…”
Electronic Execution
Benefits
“It Will…”
Execute documents electronically
without paper
Quantify test results for each test
with screenshots and supporting files
Deviation Management
Manage deviations electronically
Accelerate deviation assessment
and management through controlled
workflows
Value
“Which Means…”
Eliminates possibility of lost documents
Captures user name and date and time
stamp for each row executed
No more lost screenshots and file
attachments
Deviations assessed, resolved,
reviewed, and approved quickly
Simplifies management and tracking of
deviations
Execution Metrics
Tracks execution metrics during an
execution
Provides a clear picture of execution
including the number of tests, test
results, and deviations
Controlled workflows
User defined workflows to manage
review and approval of documents
Accelerates review and approval
Documents routed electronically in
serial or parallel
Eliminates possibility of lost
documents
Electronic Execution
Test Results are
Populated Dynamically
Screen Shots are Captured
and Populated Dynamically
at the Row Level
User ID with Date and
Time Stamp Captured
for Each Row Executed
Supporting files can be
attached at the row level
Validation Schedule Management
Features
“We have…”
Periodic review
management
Benefits
“It Will…”
Define any number of periodic
review schedules
Value
“Which Means…”
Simplify management of complex
periodic review schedules
Easily manage periodic review
schedules and associated tasks
Automatic alert
notification for upcoming
schedule tasks
Users can better plan their tasks
and avoid missing the critical GMP
system from being not reviewed as
per SOP
Ensures that critical GxP entities are
revalidated and periodic reviews
completed in a timely manner
Automatic alert
notification for delayed
schedule tasks
Take necessary actions including
expedite the periodic
review/revalidation with grace
period or initiate CAPA etc.
Mitigates risk of non-compliance
Ensures that systems stay within
defined compliance parameters
Maintain Validation Status through Assessment
Include Changes
after an
Assessment
Upcoming Periodic
Reviews and Revalidation
Tasks can be included in
an Assessment
Closed Loop Change Incident/CCR/DCR Management Process
Initiate
Incident/CCR/DCR
Review
IT Updates
Compliance
Team
Assessment
IT
Assessment
Vendor
Assessment
Initial Release
Notes
Post Approval
QA
Assessment
Validation
Update
System
QA/Compliance
Approves
Develop Release
Summary
Review/Approve
Final Release Summary
Incident/CCR/DCR
Closed
Compile and
Review
Approval
Integrated Solution for Validation Lifecycle Management Process
Validation Plan and Projects
Requirements Management
Document Development
Template Approach
Supports MS Word and Excel
Electronic Execution
Deviation Management
Automated Execution
Dash Board – Real time Status
Validation Metrics
Change Management Process
Periodic Review
Dynamic Traceability Matrix
Risk Assessment (FMEA and ASTM)
Revalidation Scheduler
Content Management
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Connector for EMC Documentum
 ValGenesis can be leveraged as user interface to Documentum to manage the
validation lifecycle process
 Taxonomy created in ValGenesis will be dynamically created in a specified
Documentum Cabinet
 Approved ValGenesis documents (Templates, Requirements, Developed
Protocols, and Executed Protocols etc.) will be available in a specified
Documentum Cabinet
 Documents authored in Documentum can be synchronized with ValGenesis to
create traceability matrix and to execute electronically, the final approved
documents will be stored in Documentum
 Reference documents such as SOPs, User Manuals etc. available in
Documentum can be bound within ValGenesis, these reference documents will
be available as hyperlinks in ValGenesis during the validation process
 Validation documents and data generated in ValGenesis are available to
Documentum users
SAP - ValGenesis Integration
SAP ERP
SAP
xMII
Architecture
–APO
Overview
CRM
PM
PP/PI
MM
QM
…
SAP NetWeaver
XI
BW
SAP xMII Core Manufacturing
Services
EP
Enterprise Service
Repository
BAPI/RFC/IDOC
Repository
oValidation Status of New Equipment
oUpcoming Period Review
oRisk Assessment Details
oMaster Recipes
oMaterial Details
oResources & Functional Locations
Industry Standard Business
Packages (e.g. S95)
Validation Status
Validation Status Update
Plant Maintenance Plan
Material Consumptions
Quality Notifications
Validation Data & Documents
Maintenance Notifications
GxP Asset Info
ValGenesis
Validation Plan
& Projects
Requirements
Management
Test Case
Management
Traceability
Matrix
Test Case
Execution
Risk
Management
Periodic
Review
Change
Management
Impact of ValGenesis Implementation
BEFORE VALGENESIS
RESULTS WITH VALGENESIS
Inconsistent Documentation
Template driven development
Improves consistencies
Review and Approval Delays
Approvals are tracked and alerts
through corporate e-mail are sent out
Ineffective Tracking
Dynamic audit trails provide real
time validation status and metrics
Missed periodic reviews
Automated alert notification to SMEs
regarding periodic reviews
Time consuming audit preparation
A click of the mouse and everything is
ready
Difficulty enforcing validation
standards and policies
Helps to enforce validation standards,
policies and procedures
Scanning documents and electronic
management
Web-based system allows for approvals
on-line with full view of documentation
Elimination of Non-Value Added Activities
Creating Binders
With Electronic Validation, Binders are no longer required
Document Storage
Documents are stored electronically in the system.
ValGenesis generates approved documents into PDF with
watermark
Locating Document in Archives
Since documents are stored electronically, there is no need to find
documents in a document archive
Tracking mechanisms available to locate bottlenecks quickly
Bottlenecks in process can be located easily
Thank You
Thank
Ph: 510 445 0505
Email: [email protected]
www.valgenesis.com