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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
Estimated Effort Required for the Validation Lifecycle
Creating, reviewing, and approving validation plans and projects
ValGenesis’ Impact
20-30% more efficient
Estimated Effort Required for the Validation Lifecycle
Authoring, reviewing, and approving validation protocols
ValGenesis’ Impact
20-30% more efficient
Estimated Effort Required for the Validation Lifecycle
Creating and maintaining traceability matrices and requirements
ValGenesis’ Impact
40-50% more efficient
Estimated Effort Required for the Validation Lifecycle
Executing, reviewing, and approving validation protocols
ValGenesis’ Impact
40-50% more efficient
Estimated Effort Required for the Validation Lifecycle
Performing, reviewing, and approving risk assessments and maintaining the validation status
ValGenesis’ Impact
40-50% more efficient
Estimated Effort Required for the Validation Lifecycle
Creating and maintaining periodic reviews (including risk management) and revalidation schedules
ValGenesis’ Impact
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
Estimated Effort Required for the Validation Lifecycle
Tracking the validation status
ValGenesis’ Impact
70-80% more efficient
Estimated Effort Required for the Validation Lifecycle
Audit preparation for internal and external audits
ValGenesis’ Impact
80-90% more efficient
Estimated Effort Required for the Validation Lifecycle
Document retrieval
ValGenesis’ Impact
70-80% more efficient
Estimated Effort Required for the Validation Lifecycle
Validation metrics for resource and budget planning
ValGenesis’ Impact
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.
