Overview

ValGenesis – Validation Lifecycle Management System Overview

ValGenesis revolutionized Life Sciences in 2004 by advocating a technology solution companies can leverage to significantly improve validation processes and relieve the paper burden of traditional validation.

The ValGenesis Validation Lifecycle Management System (VLMS) effectively manages all types of validation activities such as equipment, instruments, computer systems, cleaning, method, and process validation. ValGenesis’ VLMS spans the entire validation lifecycle delivering a singular technology solution that’s readily available, rapidly deployable in a validated cloud, and is securely fortified.

ValGenesis’ VLMS includes a regulatory framework allowing validation requirements to be specified in advance. Risk Management is integrated and flexible giving companies the ability to leverage standard risk tools to best suit their needs. Reusability is inherent and available at Test and Requirement levels, significantly improving efficiency via pre-approvals. Change Control and Periodic Review functionality ensures validation entities in the system’s Inventory maintain their validated state. Consistency is driven through standardization which improves a company’s compliance posture.

The Graphic below illustrates the expansive nature of the ValGenesis VLMS

vlms

With its intuitive interface and dashboard functionality, ValGenesis’ VLMS renders a panoptic view of the entire validation lifecycle delivering instant access, real-time status reporting, and the ability to drill-down to ever increasing levels of granularity for electronic validation document deliverables and tasks assigned to groups or individuals; furthermore, email notifications alert individuals automatically.

ValGenesis’ Validation Lifecycle Management System (VLMS) renders a panoptic view of the entire validation lifecycle

Features

There are many features available with the ValGenesis’ Validation Lifecycle Management System (VLMS). Below are just some of them:

AUTOMATIC

The system automates your entire validation lifecycle

COMPREHENSIVE

Anything that can be validated can be managed in the system

PAPERLESS

Documents are developed & managed electronically

INTEGRATED

Built on an industry standard platform and tightly integrated with Word & Excel

NOTIFIED

Status is available via the on-line dashboard and via email notifications

COMPLIANT

Enhances compliance with a Regulatory Framework & Risk Management

AVAILABLE

Software as a Service (SaaS), cloud-based system available 24/7/365, globally

RE-USEABLE

Test Functions allow reusability of pre-approved test scripts

EXTENSIBLE

The systems modularity allows you to use what you want, and grow from there

DEPLOYABLE

The system is available in a validated cloud making deployment rapid

PANOPTIC

The system’s interface provides a view of the entire validation lifecycle

The above only represents some of the features of the ValGenesis VLMS. Contact ValGenesis today to arrange for a demonstration of the entire system, and to discuss your specific needs and requirements

ValGenesis’ Validation Lifecycle Management System (VLMS) features everything you expect, and more…

Process

The ValGenesis’ Validation Lifecycle Management System (VLMS) is comprehensive spanning the entire validation lifecycle. Following is a very high-level explanation of the process.

First, companies configure the system to meet their specific needs. Documents are then developed in the system leveraging Microsoft Word or Excel. Documents are routed through approval cycles. Once approved documents (e.g., test scripts) are executed. Trace Matrix is automatic, and maintained current. Deviations are captured and managed electronically. Once complete, with deviations resolved, documents are routed for final approval. Once approved documents are always readily accessible. If revalidation is required all one needs to do is update existing documents, as appropriate, and then initiate validation through the workflows.

If companies choose to leverage the ValGenesis’ Test Functions, then when developing documents users simply choose from a library of pre-approved test scripts to expedite the document development.

If companies choose to use Risk Management features then risk can be assessed at the system or even the requirement level. This propagates throughout the system, thus ensuring regulatory compliance and consistency. Should a change occur, then associated impact assessments are expedited, and compliant, because risk has already been determined and the Trace Matrix is maintained linking all associations to validated systems, documents, and even requirements.

Bottom line, the process is significantly more efficient with cost and effort savings at approximately 50% over traditional validation processes.

Benefits

The ValGenesis Validation Lifecycle Management System (VLMS) is a disruptive technology forever changing the way Validation is performed.

ValGenesis’ VLMS makes validation less burdensome by driving towards paperless processes with electronic deliverables that are processed through defined and pre-approved workflows.

Electronic signatures significantly improve approval cycles. Automatic notifications make sure the right individuals are informed at the right time.

Regulatory and Validation Frameworks ensure consistency and adherence to legal requirements. Risk management functionality is available allowing companies the ability to leverage their preferred risk-based tools.

Reusability is achieved by template functionality and the system’s Test Functions feature offers the ability to develop libraries of test scripts users can select to expedite test protocol development.

Bottom line, by implementing the ValGenesis VLMS customers have realized effort and cost savings up to approximately 50%. Call today to see the system live and to discuss how you can also benefit from implementing the ValGenesis VLMS.

ValGenesis’ VLMS is a disruptive technology forever changing the way Validation is performed in the Life Sciences industry

 

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