The Most Feature-Complete System for Digitizing the 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.