Our Implementation methodology is designed to deliver enterprise validation lifecycle management solutions based on aggressive timelines, with well defined deliverables. Combining industry-standard System Development Lifecycle (SDLC) practices, with the Rapid Implementation Approach, enables us to deliver solutions tailored to your company’s unique validation, quality, compliance and regulatory requirements.

ValGenesis’ Rapid Implementation Approach comprises of seven main phases, tailored individually to meet the specific implementation and resource needs of your company, with defined deliverables. These phases ensure that each part of the project is given the appropriate level of attention, this guarantees a successful implementation, on time and within budget. Our methodology optimizes resources and streamlines your ValGenesis implementation process.

Gather and Analyze Configuration Requirements

In this phase, the ValGenesis team will analyze the current validation and quality processes and associated challenges. ValGenesis will provide comprehensive templates to gather configuration requirements, based on the current process, the ValGenesis team will work with stakeholders and Subject Matter Experts (SMEs) at client sites, to illustrate the value-added functionality and built-in best practices that ValGenesis will deliver to standardize and harmonize the corporate validation process.

This phase maps client specific process-flow against product features, functions, and capabilities. The output from this phase helps define the specific business processes that will be implemented to address the business and operational goals outlined by the customer requirements.

Deliverables: Approved design and configuration requirements document.

Configure/Design

This phase delivers a configured ValGenesis system, based on the approved design and configuration requirements document. As well as configuration, data migration can be accommodated from the existing manual, or legacy system.

We execute rigorous unit and end-to-end functional testing to ensure that the configured system performs consistently and meets all requirements. The testing includes reviewing the configured system against client approved configuration requirements.

Deliverables: Configured and tested ValGenesis Software system, based on client specific configuration.

Conference room Pilot and readiness Assessment

The configured ValGenesis system, based on the approved client requirements, will be installed on the client’s pilot, or ValGenesis’s hosted, server.  The ValGenesis team will assist clients by creating and reviewing the system at the pilot level.  This plan must be representative of the production process, so that all functions can be tested.  This phase helps to maximize the effectiveness of the implementation by providing an in-depth analysis of the project status and readiness to implement.

A readiness assessment is a review of the project objectives and goals. This will determine if they have been met and what the overall project status, in relation to the ability to go to production with the application. ValGenesis Professional Services has developed a functional audit form, based on the approved requirements, so the client and ValGenesis teams can use this form to determine the project status.

Validation

ValGenesis provides a pre-configured Operational Qualification (OQ) package and support to develop a Performance Qualification (PQ) package, based on client specific configuration requirements, to meet the stringent regulatory demands for software validation. These packages reduce the validation effort significantly.  A critical part of our product offering is providing superior validation support. Our team can also help develop the overall plan for validation, create tailored scripts, assist with execution of the test plans, and provide detailed documentation.

Automated Validation Framework

ValGenesis has developed an Automation Framework to validate ValGenesis instances, using this framework the configured ValGenesis system can be validated automatically, including dynamic traceability matrix generation, dynamic test case generation and automated execution. Generated and executed test cases contents will be routed for review and approval, through the controlled workflows available in ValGenesis. The entire validation process can be done in approximately 2-3 business days.

Finally, ValGenesis VATS can compile the executed test cases into a single file, in PDF format, with all the screenshots appended in the same document. The approved PDF document can be stored in your document management system. When audited by the FDA, or other governing body, validation reports are immediately available for review.

Training

ValGenesis offers a full range of flexible training programs that can be tailored to fit your needs.  Training is available both on-site and via online training sessions.

On-Site - Customers can request on-site training any time they have enough participants to make this an economical option. This is very effective when a group of people needs to be trained at the same time.

Online Training – A ValGenesis training professional will train clients over the web. This can be very effective if users are scattered across different locations.

Go Live

We help you launch your Track Wise system – on time and within budget – and seamlessly transition you to our solutions support team. The final phase delivers a smooth transition and cut-over to the newly configured solution.