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Modules
Overview
An overview of ValGenesis's Validation Lifecycle Management System (VLMS)
GxP Assets Management
Manage the lifecycle of GxP assets with a documented audit trail
Validation Plan &
Framework
Maintain a consistent approach across all validation processes and sites
Validation
Projects
Manage complex validation projects with required quality gate checks
Requirements Management
Manage change requirements as a closed loop validation process
Document Lifecycle Management
Track documentation from design to change management and validation
Dynamic Trace
Matrix
Identify and fix defects related to important requirements
Electronic Test Case Execution
Execute test cases quickly and securely, anywhere at any time
Robotic Test Case Execution
Reduce execution time by up to 90% by removing human errors
Periodic Review Management
Identify and manage the review schedules of validated GxP systems
Risk-Based Validation
Evaluate and control risk at functional and/or system levels
Change Control & Management
Track and efficiently manage any type of change request
Equipment Log Management
Record, verify, and review logs as per approved SOPs/standards
Retirement & Decommissioning Process
Plan and execute the entire process with required quality gate checks
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Solutions
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Solutions
Overview
An overview of ValGenesis's Paperless Validation Software Solutions
Computer Systems Validation
Error-free, paperless, fully automated lifecycle management process
Equipment & Instruments Validation
Quick access to data and validated state of equipment
Cleaning Validation
Integrated, seamless lifecycle process across multiple groups and sites
Analytical Method Validation
Error-free, paperless, integrated analytical method lifecycle validation
Process Validation
Seamless connectivity across process, data, and knowledge management
Facility Commissioning & Qualification
Risk-based commissioning and qualification process
Cold Chain Validation
IoT capable validation for temperature controlled supply chains
eLog Book
Verification and review (with e-signature) of equipment logs at point-of-need
VConnect – SDMS
Data captured from equipment is plugged into all documentation/evidence
Validation Centric ALM
Accommodate every change while maintaining validated status
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Services
Platforms
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Platforms
Technology
Addressing critical technology elements for any life science enterprise
SaaS
Manage critical validation, quality/regulated data and documents in the secured cloud
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Compliance
Industries
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Industries
Blood & Tissue
Consistently meet Blood Establishment Computer Software (BECS) Requirements
Contract Organizations
Enforce approved validation plans to be audit-ready without preparation
GxP Laboratories
Ensure data integrity and get organized with automated audit trails
Medical Devices
Seamlessly manage Design History Files (DHF) across all units and sites
Nutraceutical
Single environment requirements management, simplifying proof of compliance
Pharma/Biotech
Achieve standardization and data integrity via seamless processes
Regulated Software Companies
Quickly release new versions/ service packs with our test automation engines
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Resources
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Resources
Overview
A quick snapshot of our library of resources
Press Releases
Check for the latest information from our newsroom
Blogs
Stay informed and up to date on hot topics and current events
Webinars
Access our library of on-demand webinars
Events
Check the calendar of events we are attending this year
Client Stories
See what clients say about our suite of validation services and solutions
White Papers
Access our library of educational white papers
Videos
Access our library of educational videos on validation
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Meet ValGenesis
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Meet ValGenesis
About Us
A global organization established in 2005 in South San Francisco, CA
Clients
Working with life science organizations, including several Fortune 500 companies
Partners
Building on the strengths of partners to add significant value to services and solutions
Contact Us
Wide support network to assist clients across the globe
Careers
A talented, well qualified team - the backbone of our success
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Product
Overview
GxP Assets Management
Validation Plan & Framework
Validation Projects
Requirements Management
Document Lifecycle Management
Dynamic Trace Matrix
Electronic Test Case Execution
Risk-Based Validation
Robotic Test Case Execution
Periodic Review Management
Change Control & Management
Equipment Log Management
Retirement & Decommissioning Process
Solutions
Overview
Computer Systems Validation
Process Validation
VConnect – SDMS
Equipment & Instruments Qualification
Facility Commissioning & Qualification
Validation Centric ALM
Cleaning Validation
Cold Chain Validation
Analytical Method Validation
eLog Book
Services
Platforms
Technology
SaaS
Compliance
Industries
Blood & Tissue
Nutraceutical
Contract Organizations
Pharma/Biotech
GxP Laboratories
Regulated Software Companies
Medical Devices
Resources
Overview
Press Releases
Blogs
Webinars
Events
Client Stories
White Papers
Videos
Meet ValGenesis
About us
Clients
Partners
Contact Us
Careers
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RESOURCES / Blogs
Blogs
Recent Posts
FDAs Computer Software Assurance (CSA) – Part 1 of 3
Why Validation projects fail
Digital Transformation/Pharma 4.0: Impressive technology, but what about people?
Genesis of Validation: Personal, Professional And Public
Chaos to Continual Improvement – A Journey Facilitated by ValGenesis
10 reasons to adopt paperless validation
Managing Cybersecurity (SaaS environment)
FDA approves record number of drugs in 2018
ValGenesis is GDPR-Friendly
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Recent Posts
FDAs Computer Software Assurance (CSA) – Part 1 of 3
Why Validation projects fail
Digital Transformation/Pharma 4.0: Impressive technology, but what about people?
Genesis of Validation: Personal, Professional And Public
Categories
Data Security (1)
Validation (14)
Compliance (5)
Data Integrity (5)
Industry (9)
Pharma (1)
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Pharma and Biotech
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Process Validation
Instrument/Equipment Validation
Method Validation
Cleaning Validation
Facility Commissioning & Qualification
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