Careers Contact Us Blog
Products Solutions Services Industries Meet ValGenesis
Schedule a Demo

ValGenesis VLMS

The complete Validated Lifecycle Management System from ValGenesis is the industry-leading solution for digitizing the entire validation lifecycle.

ValGenesis VLMS Express

Simplified, cloud-based digital validation. Designed for small and mid-sized life sciences companies.

ValGenesis e-Logbook

Web-based electronic logbook software built for pharma, biotech and other life sciences for 100% paperless logbook management.
Paperless Validation SoftwareAn overview of ValGenesis Paperless Validation Software Solutions Cleaning ValidationIntegrated, seamless lifecycle process across multiple groups and sites Commissioning Qualification ValidationRisk-based commissioning and qualification process Computer System ValidationError-free, paperless, fully automated lifecycle management process Analytical Method ValidationError-free, paperless, integrated analytical method lifecycle validation Cold Chain ValidationIoT capable validation for temperature controlled supply chains Equipment and Instruments ValidationQuick access to data and validated state of equipment Electronic Logbook ManagementVerification and review (with e-signature) of equipment logs at point-of-need Process ValidationSeamless connectivity across process, data, and knowledge management VConnectData captured from equipment is plugged into all documentation and evidence Hands-Free ValidationAugmented reality validation software for remote, hands-free validation Mobile App for ValidationOnline and offline validation process completion
Pharmaceutical and BiotechnologyAchieve standardization and data integrity via seamless processes Medical Devices and DiagnosticsSeamlessly manage DHFs across all units and sites GxP LaboratoriesEnsure data integrity and get organized with automated audit trails Blood and TissueConsistently meet Blood Establishment Computer Software (BECS) Requirements Regulated Software CompaniesQuickly release new versions/ service packs with our test automation engines Contract Research OrganizationsEnforce approved validation plans to be audit-ready without preparation NutraceuticalsSingle environment requirements management, simplifying proof of compliance
Meet ValGenesisExplore the company's history, values and more. CareersValGenesis is hiring! Check out latest openings in our diverse, dynamic team. LeadershipMeet our management team, board and advisors. PartnersOur global partner network brings ValGenesis to customers worldwide. Upcoming EventsMeet the ValGenesis team at these upcoming industry events. Contact UsReach out to learn more about products, partnerships, support and more. ValGenesis BlogExplore key industry insights in validation, life sciences and more. ValGenesis NewsThe latest ValGenesis corporate announcements. ValConnect: The ValGenesis User Conference

Process Validation Software Designed for the Life Sciences

Eliminate data integrity issues. Ensure consistent product quality.

Solutions Process Validation

The FDA defines process validation as, “the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering a quality product.” The key word here is consistently. Product quality in the context of process validation means that product performance is consistently acceptable from batch-to-batch and unit-to-unit. 

Historically, companies managed process validation with paper-based documentation. This becomes increasingly difficult as regulatory complexity rises. The FDA and other regulatory organizations encourage a risk-based approach for your process control and validation. The FDA’s Case for Quality initiative identifies Quality by Design (QbD) as a best practice that considers critical material attributes (CMA), critical process parameters (CPP), and critical quality attributes (CQA) in assessing risk. Regulators also encourage you to adopt a lifecycle approach to validation. To stay ahead, life sciences companies of all sizes are turning to digitization to streamline the process validation lifecycle.

On this page:

What Makes Paper-based Process Validation So Challenging?

There are several challenges in traditional paper-based process validation.

  • Isolated data silos: Paper-based systems promote data silos where there is no integration between the three stages of process validation: process design, process qualification, and continued process verification. Knowledge resides with one group or one person, leading to an organizational dependency on personnel instead of processes.
  • No audit trail: In a manual system, risk assessment and mitigation activities are maintained in spreadsheets and paper documents, making it difficult to maintain an audit trail. You must make human readable audit trails readily accessible to auditors as objective evidence of compliance.
  • Increased risk: Manual systems are prone to data integrity issues, noncompliance incidents, poorly developed process control strategies, and a lack of visibility when it comes to the qualification status of equipment. All of these deficiencies increase risk.
  • Long cycle times: A manual system is inherently inefficient. There are constant delays and errors caused by paper-based validation documents and manual protocol execution. These inefficiencies lead to longer cycle times and delayed production.
  • Slow turnarounds: In a paper-based system, batch number identification for performance qualification must be done manually. Also, control charts and statistical reports for annual product reviews must be prepared by hand. Automation helps sustain compliance by simplifying these processes.
Process Validation in action
Return to top

Benefits of Digitizing Your Process Validation Efforts

The ValGenesis Validation Lifecycle Management System (VLMS) is a cloud-based platform designed to automate and simplify all areas of a life sciences company’s complex validation needs—including equipment and instrument validation, cleaning validation, analytical method validation, facility commissioning qualification, and more. The time- and cost-saving benefits of our fully automated process validation solution include:

Complete, compliant system: ValGenesis offers users a lifecycle approach to process validation in compliance with 21 CFR Part 11, Annex 11 and ALCOA data integrity principles. The solution also complies with the FDA Guidance for Industry: Process Validation: General Principles and Practices (2011) and enables cGMP regulations for validating pharmaceutical (drug) manufacturing processes to meet all the attributes they are intended to possess: 21 CFR 211.100(a) and 211.110(a).

Holistic validation management: The solution is tightly coupled with other ValGenesis solutions, including analytical method validation, cleaning validation, and equipment and instrument validation, for a holistic approach to validation management.

Risk-based approach: Using risk assessment models, our VLMS helps you conduct a risk assessment and mitigation plan for process design, parameters and attributes (e.g., CMA, CPP and CQA). The risk assessment approach is also used to identify the number of batches to be taken as part of process performance qualification (PPQ) with required justification and approvals.

Increased data integrity: Our VLMS dynamically collects the critical control points (CCPs), as per the predefined schedules, and updates batch records to eliminate human error and provide a higher degree of data integrity.

100% paperless: With ValGenesis, all validation deliverables are created, reviewed and approved electronically, entirely eliminating paper from the validation process.

Process validation master plan: Our process validation master plan drives all stages of process validation and enforces the required studies and deliverables at every stage with required dependencies between studies and deliverables.

Return to top
Process Validation features with ValGenesis

Improve Process Validation with These Unique Features

With ValGenesis VLMS maintaining your organization's process validation efforts, you'll enjoy a host of robust features and functions, including:

  • Assessments powered by decision-tree logic
  • Real-time information on the validation status of your products
  • Applied critical thinking with procedural risk assessments at system and functional requirements levels
  • Automatic task notification, schedules, and nudging features with email 
  • Integrated close-looped process validation lifecycle management
  • Controlled template management and approval 
  • Workflow management 
  • Automated trace matrix generation 
  • Real-time collaboration with remote and distributed teams
  • 21 CFR Part 11-compliant features like time-stamped audit trails, reporting, and electronic signature capabilities 
Return to top

Ready to join the digital validation revolution?

Avoid process disruptions in your manufacturing network with our risk-based, end-to-end solution.

"We reduced cycle time more than 50% and gained data integrity in our validation process."

"Validation-related observations dropped 90% after implementation."

"We can easily manage validation deliverables and change requests across global sites with full data integrity."

Fill out the form to request a demonstration of the ValGenesis VLMS.