ValGenesis VLMS: Features

The Most Feature-Complete System for Digitizing the Validation Lifecycle

Highlight Features of ValGenesis VLMS

Single Source of Truth

Eliminate fragmented data silos and processes with a united platform for all validation activities.

AI Innovation

Gain intelligent insights across validation activities to unlock unprecedented operational efficiency.


Establish risk-based requirements and execute both automated and unscripted testing.

Offline Support​

Use the mobile app to complete key validation tasks offline for contemporaneous evidence capture.

PDF Execution

Execute validation activities directly from PDF documents, including vendor documentation.

Dynamic Trace Matrices​

Automatically link requirements and documentation to generate traceability matrices in real time.

Built for Agile​

Stay nimble and responsive with software built for the agile workflows.

Periodic Reviews and Tasks

Establish periodic review schedules with dynamic calendars to enforce consistency and safeguard compliance.

Audit Trails

Adhere to ALCOA+ data integrity principles with a robust, immutable audit trail of all activities.

Electronic Signatures 

Execute and approve documentation with Part 11-compliant electronic signatures.

Change Control

Assess updates to validation deliverables at the requirement or system level to verify the entity's state of validation.

Robust Reporting

Define regular, automatic reports or compile ad hoc reports to monitor all validation activities.

Scale without compromise:

Industry-Leading Architecture

Deploy on validated, redundant, and regionally sovereign Microsoft Azure data centers.

Expand to multiple sites, multiple languages, and multiple validation lifecycles.

Grow with total confidence with ValGenesis VLMS.

FDA 21 CFR Part 11 Compliant
EU Annex 11 Compliant
ISPE GAMP 5 Certified
SOC 2 Type 11 Compliant
ISO 27001 Certified

Explore the Modules of VLMS

ValGenesis VLMS is a tightly integrated set of modules that are configured for maximum user productivity within your specific environment and validation lifecycle.

Content Manager centralizes content management, performing all content-related tasks with additional control over content usage and application, including discrete templates for different content types.

Design Manager enables compliance with the FDA’s computer software assurance (CSA) guidance. Develop risk-based requirements upfront and perform both scripted and unscripted testing to reduce unnecessary documentation to “right size” validation efforts. Learn more about how VLMS supports CSA.

Execution Manager empowers customers to perform all validation tasks 100% digitally, managing execution from initiation to final approval. Deviation management, split execution, dry runs, and the ability to attach screenshots and other files as objective evidence are critical features.

Assessment Manager is a powerful tool to reduce risk and improve quality. It enables decision-tree logic to enforce standardized frameworks that determine validation deliverables and the validated state of an entity.

Change Manager manages updates to validation deliverables, either at the requirement or system level. If a deliverable is changed, an authorized individual must verify whether the entity is still in a validated state. This “change impact” functionality aids during audits and inspections by highlighting entities that may have been affected by a change.

Requirement Manager automatically generates traceability matrices by visualizing the relationship between requirements and executable documents. Maintaining a closed-loop requirements change management process eliminates the need to manually manage traceability in spreadsheets, minimizing compliance risk and saving significant time.

Risk Manager enables risk-based validation via FMEA, Risk Priority Number (RPN), and any other risk model, including custom models. Custom models support multifactor risk assessments, configurable calculations, and derivatives that drive logic and outcomes.

Report Manager empowers users to generate comprehensive reports effortlessly. Its extensive features and variety of report types, including support for both regular and ad hoc reports, allow teams to precisely compile and organize process intelligence.

Schedule Manager delivers accurate and relevant validation materials aligned with the user's predetermined schedule. Using a checklist approach for periodic reviews, the system ensures consistency and completeness while integrating calendars to manage shifts, holidays, and company shutdowns.

Vault Manager provides document repositories and storage capabilities, allowing users to quickly locate, view, and search documents. The intelligent file recovery system acts as a safety net by automatically saving works in progress. Vault Manager can also create PDF file packages for virtual audits and inspections.

Project Manager empowers users to effortlessly establish project plans and define deliverables, dependencies, and due dates for seamless workflows. Tasks are automatically initiated with dependencies between validation deliverables to ensure they are performed in order and no crucial details are overlooked.

System Manager allows teams to configure various objects and settings, such as workflows, electronic signatures, functional roles, reference folders, business rules, and process templates, before any validation activities commence.


ValGenesis integrates with many major software applications commonly used in regulated environments, including ERP, QMS, and MES.

Our comprehensive API stack allows for bi-directional integration between ValGenesis VLMS and other business systems. Similarly, VLMS can call third-party APIs to provide status updates on validation activities to other systems.

Integration plays a pivotal role in digital transformation roadmaps by automating data exchanges without manual intervention.

Get a complete tour of ValGenesis VLMS and see all of its industry-leading features.