Comparing Kneat, ValGenesis, Veeva Vault, Valkit.ai, and others
Digital validation tools (DVTs) are an effective alternative to paper-based validation for life sciences companies that make validation faster, speeds time-to-market, and protects compliance and data integrity.
ValGenesis is a well-known digital validation software known for its extensive marketing presence and smooth-looking interface. Some customers have found that the ValGenesis platform lacks flexibility and support compared to other platforms. This article explores the best ValGenesis alternatives based on platform type, functionality, user experience, and brand reputation.
Alternatives to ValGenesis
Validation involves many teams from across an organization. It spans the entire production life cycle and is required on everything from process planning to equipment upkeep. As such, many platforms have features that can be used for a portion of validation. It’s recommended by experts that validation be fully digitalized in either a single platform or an integrated network of platforms.
Quality management systems
Quality Management Systems (QMS) have a lot of overlap with validation processes and are arguably the most related to the validation function outside of dedicated validation platforms. These platforms typically involve features that help organizations manage:
- Change control
- CAPA management
- Audits
- Deviations
Organizations can use QMS to manage validation documentation, including protocols, reports, and specification documents. However, a QMS doesn’t typically help create these documents, requiring another method to produce these vital components. Any out-of-system document management creates data integrity risks that could threaten compliance.
Some of the major QMS platforms for life sciences companies include:
- Veeva
- MasterControl
- Trackwise
Using QMS for validation-related functions
| Function | Description | Capability |
|---|---|---|
| Document Management | Digital accessibility, version control, archiving, etc. | Good, but varies system to system |
| Test Execution | Real-time test step execution and data capture | Limited – typically stores only completed protocols |
| Reporting and Dashboards | Validation metrics, statuses, KPIs | Good, specifically for quality and document status |
| Traceability Matrices | Requirements or risk tracing and linking | Limited, manual creation necessary |
| Audit Trails | Complete electronic records | Excellent, a standard function of most QMS |
| Data Integrity | ALCOA++ principles | Limited, but good, for the areas of validation it addresses |
| Deviation Management | Handling test failures or unexpected results | Good when integrated with a CAPA system. |
Application lifecycle management
Application lifecycle management (ALM) software is another alternative to validation platforms such as ValGenesis. These are frequently already deployed across most organizations with complex manufacturing needs, especially medical device manufacturers. ALMs manage the entire lifecycle of a software application, which makes them relevant to many Computer System Validation (CSV) or Computer Software Assurance (CSA) requirements.
Some of the most popular ALM platforms include:
- Jira
- Azure DevOps
- Polarion
Using ALMs for validation-related functions
| Function | Description | Capability |
|---|---|---|
| Document Management | Digital accessibility, version control, archiving, etc. | Good, for requirements and test cases. |
| Test Execution | Real-time test step execution and data capture | Good, typically tracks with pass/fail. |
| Reporting and Dashboards | Validation metrics, statuses, KPIs | Excellent. |
| Traceability Matrices | Requirements or risk tracing and linking | Very good for core functionality and tracing to other documents within platform. |
| Audit Trails | Complete electronic records | Good, but may lack certain GxP-specific requirements. |
| Data Integrity | ALCOA++ principles | Limited, ALMs are not designed with 21 CFR Part 11/ Annex 11 in mind. |
| Deviation Management | Handling test failures or unexpected results | Good, defect tracking and management is a common feature. |
ALMs are capable alternatives to ValGenesis across many stages of CSV management. However, they may not be effective for early stages of validation, including process mapping, workflow establishment, and user requirement logging.
Validation alternatives to ValGenesis
The most recommended way of managing digital validation is through a digital validation tool (DVT) or platform, such as Kneat Gx, ValGenesis, or others.
Comparing ValGenesis competitors
The top validation platforms which are viable alternatives for ValGenesis include:
- Kneat Gx
- Veeva Vault
- Valkit.ai
Any DVT will eliminate, or at minimum significantly reduce, the reliance on paper-based practices. There are many requirements a platform should also satisfy and for the purpose of comparison, we will examine:
- Test execution
- Audit readiness
- Platform flexibility
- Ease-of-use
- Industry trust
| Category | ValGenesis | Veeva Vault | Valkit.ai | Kneat Gx |
|---|---|---|---|---|
| Audit Readiness | Good, automatic data integrity protection and digital document management for easier reporting | Excellent, audit trail generation and virtual Audit Room for external parties. | Fair, standard benefits of digital validation, such as digital access to documents and automatic audit trails. However, no evidence of more advanced features. | Excellent, built in data integrity protections from beginning to end, virtual audit room, and numerous features purpose-built for life sciences regulations. |
| Ease-of-use | Poor. Online reviews cite style over substance and clunky interface. | Good. Those already familiar with Veeva’s platform will learn quickly. May be a steeper learning curve for those who aren’t. | Indeterminate. New to the space, Valkit’s marketing is untested. However, AI features in other platforms have been effective in limited deployment with dedicated human oversight. | Excellent, Kneat has won multiple awards for user experience and customer satisfaction. Multiple published case studies cite ease of use as a key differentiator. |
| Industry trust | Fair, ValGenesis is used by several life sciences companies. | Good, Veeva’s broader quality platform is well respected, but their validation module is new to the space. | Poor. Valkit launched in 2023 and is still building a reputation. They are, however, advised by some industry experts. | Excellent, used by 8/10 top global life sciences companies, Kneat is purpose-built for the industry. |
| Platform flexibility | Good, ValGenesis promotes capabilities across numerous validation disciplines. | Limited. Veeva Vault is an effective CSV solution but hasn’t released functionality for CQV or other disciplines. | Indeterminate. The website cites CQV as well as CSV but stops short of promising comprehensive validation. | Excellent, Kneat manages every validation discipline and needs while enabling customers to adopt their own unique workflows. |
| Test execution | Good, but offline test execution carries data integrity risks. | Good, but limited to CSV and some CQV at this point. | Fair, promises AI generated testing workflows. Human review/approval. | Excellent, online test execution protects data integrity and has many features to streamline testing, review/approval, and even re-testing requirements. |
Recap: Kneat is the best alternative to ValGenesis
The best alternative to ValGenesis is Kneat Gx. For validation needs, a digital validation platform provides more comprehensive benefits. Other platforms may partially meet requirements, but unmet needs will require paper-based approaches or additional platforms. Either way, these become weak points in an overall process, presenting compliance risk, additional resources, and wasted potential.
Other key differences that make Kneat a good alternative for ValGenesis include:
- Low data storage costs
- Lower support costs
- Lower consulting costs
- Excellent technical and process support
When comparing digital validation platforms, it’s important to plan for the future, while also relying on evidence. Validation is too important to go with untried solutions, and Kneat Gx is a proven platform with customer-informed roadmap that addresses emerging trends.
