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Paperless Validation Software Solutions

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

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

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

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

Our Paperless Validation Solutions

Leverage ValGenesis technology to accelerate CSV and enable risk-based CSA with a single, flexible digital platform that incorporates both.

CSV and CSA Implementation

Be confident your analytical methods support informed decision-making with precise, accurate, and stable data to ensure product safety, quality, and regulatory compliance.

Analytical Method Validation

Achieve a controlled state of validation with automated tasks, managed scheduling, and a reusable content library that supports a family approach to equipment and instruments validation.

Equipment and Instruments Validation

Simplify process validation by electronically collecting and evaluating data from design stage to production, providing scientific evidence of product quality and safety.

Process Validation

Ensure your facilities, equipment, and systems are designed and installed as specified and function as intended.

Digital Commissioning and Qualification

ValGenesis's paperless validation software solution makes the end-to-end validation lifecycle process 100% digital, reducing validation cycle time by over 50%.

Paperless Validation

Incorporate agile methodology into your software validation processes to ensure product quality and patient safety.

Software Development Lifecycle Management

Learn More From Our Experts

Blog Post

Digital CPV

What is a Multi-Site Digital CPV, and Why Should You Want It?

Read the Blog Post

Industry Insight

Risk and Data as Knowledge Enablers: A Lifecycle Approach

Read the Article

Webinar

Challenges and Solutions: A Deep Dive Into Digital CQV

See how ValGenesis can support your digital transformation.