Paperless Validation Software Solutions

All the validation tools you need to boost productivity and accelerate compliance.

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A 100% paperless validation process makes the entire validation lifecycle more efficient and cuts effort and cost by >50%.

Paper-based validation is prone to human error. It stifles innovation, increases compliance risk, and hinders time to market. These inefficiencies cost regulated companies tens of millions of dollars annually.

Companies that do not use paperless validation software face significant challenges: the high costs associated with risk management, validation, and the subsequent change management and continued qualification to maintain the validation status throughout the lifecycle of entities. In fact, traditional paper-based validation costs can represent almost one-third of the total resources required for an implementation.

The ValGenesis Validation Lifecycle Management System (VLMS) is designed to manage the entire validation lifecycle electronically and remove the inefficiencies that plague paper-based processes. This 100% paperless validation solution reduces the cost of validation by optimizing and stabilizing existing processes and procedures. Customers say their validation lifecycle processes have improved by 50% or more simply by implementing and harnessing the power of the ValGenesis VLMS.

ValGenesis Optimizes Core Validation Activities

In regulated companies, core validation activities constitute 80% of the overall validation lifecycle.

Estimated Effort Required for the Validation Lifecycle ValGenesis’ Impact
Creating, reviewing, and approving validation plans and projects 20-30% more efficient
Authoring, reviewing, and approving validation protocols 20-30% more efficient
Creating and maintaining traceability matrices and requirements 40-50% more efficient
Executing, reviewing, and approving validation protocols 40-50% more efficient
Performing, reviewing, and approving risk assessments and maintaining the validation status 40-50% more efficient
Creating and maintaining periodic reviews (including risk management) and revalidation schedules 40-50% more efficient

ValGenesis Also Optimizes Supporting Validation Activities

Supporting validation activities consist of 20% of the overall validation lifecycle.

Estimated Effort Required for the Validation Lifecycle ValGenesis’ Impact
Tracking the validation status 70-80% more efficient
Audit preparation for internal and external audits 80-90% more efficient
Document retrieval 70-80% more efficient
Validation metrics for resource and budget planning 50-60% more efficient

A 100% paperless validation solution is the only path forward for pharmaceutical, biologics, and medical device companies as they seek to harness the promise and power of Industry 4.0 and Pharma 4.0.

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