Ask the Expert: Insights on Digital Validation With Kneat Gx

For CDMOs, efficient and compliant validation processes are critical to staying competitive. Kneat Gx has transformed how these companies approach validation. To provide actionable insights, we interviewed Kneat Gx expert Kailash Rathi, Director, Quality Systems & Validation at ReciBioPharm — a world-leading pharma and biologics CDMO.

From getting started to uncovering time-saving techniques, his practical experience offers valuable guidance for professionals looking to optimize their use of our digital validation tool.

1. Getting Started With Kneat Gx

What features or configurations were most helpful in getting started?

One of the standout features that made onboarding with Kneat Gx seamless was its user interface, which closely mirrors Microsoft Word. As Rathi explained, this familiarity significantly reduced the training time for end users.

This ease of use is a game-changer compared to other software solutions that often come with steep learning curves. Many tools require users to adapt to unfamiliar interfaces, but Kneat’s design ensures that even those with minimal training can navigate the platform effectively. Tasks such as bolding text, inserting tables, or editing documents — often sources of frustration with other tools — are straightforward in Kneat, making it accessible to all levels of users.

Moreover, the initial setup process benefited from Kneat Gx’s modular design, allowing ReciBioPharm to tailor configurations to meet specific validation needs. For example, they customized document types to differentiate between vendor qualification documentation, external documents (e.g., certifications), and equipment-specific documents (like ETOP). This strategic categorization ensures users can easily locate files as the database grows.

“It’s all about simplifying the user experience,” Rathi noted. “Kneat allows us to hit the ground running, enabling quick adoption across the team while reducing downtime during the transition.”

For teams just starting with Kneat Gx, the key takeaway is to focus on leveraging the software’s intuitive design and configurable structure. With the right setup, new users can quickly adapt, ensuring a smooth and efficient onboarding process. 

2. Daily Workflow With Kneat Gx

What’s your daily routine like when using Kneat Gx?

For ReciBioPharm, Kneat Gx is the backbone of their validation processes. From drafting and reviewing to managing approvals and storing vendor documents, the platform handles everything. Document categorization, like tagging vendor files as “VNDR,” ensures quick and efficient searches, saving significant time in day-to-day operations.

The organization also extends Kneat Gx’s use to QC sample management. By digitizing forms, they created a streamlined workflow that includes sample requests, analysis, and results in one location, serving as a “mini-LIMS” for their QC team. Additionally, electronic forms have replaced traditional logbooks and paper-based access request forms, enhancing both efficiency and data integrity.

3. Time-Saving Techniques

What are your top shortcuts or efficiencies?

Rathi shared several practical tips for optimizing workflows:

• Streamlining Approvals: Consolidating related documents into a single type reduces the number of approval cycles, saving time and effort.
• Effortless Archiving: The ability to move files directly to an archive folder without requiring a review cycle simplifies document management.
• Change Tracking: Instead of creating full change controls for every update, the team uses a change log form. This approach is faster and ensures compliance without unnecessary administrative work.

4. Integrating Kneat Gx With Other Systems

Are there tips for using Kneat Gx with other tools or systems?

Integration success starts with planning. Rathi emphasized the importance of understanding your business case and considering future scalability. Over-customization, such as creating too many document types or properties, can complicate workflows and slow down system performance.

Another best practice is thoughtful folder hierarchy. For multi-site organizations, this team used shared folders for common documents like User Requirements, ensuring seamless collaboration while maintaining site-specific structures.

5. Advanced Features for Review and Execution

What are the best time-saving features for document review and execution?

The “compare” feature is a favorite among users. It highlights changes between document versions, allowing reviewers to focus only on updates. For execution tasks, keyboard shortcuts speed up data entry.

Key Recommendations

To maximize the benefits of Kneat Gx Rathi recommends validation teams:

• Leverage its intuitive design for quick onboarding and reduced training time.
• Strategically configure document types and properties to ensure scalability.
• Use features like change logs and compare tools to streamline validation processes.
• Plan folder hierarchies for efficient collaboration and document sharing.

Final Thoughts

From simplifying onboarding to uncovering advanced features, Rathi’s insights demonstrate how Kneat Gx empowers his validation team at ReciBioPharm to work smarter.

By following these best practices, professionals can save time, improve compliance, and fully leverage the platform’s capabilities.

Ready to streamline your validation processes with Kneat Gx? Book a 1-1 demo now to learn how we can help you transform your workflows!

About the Expert

Kailash Rathi, Director, Quality Systems & Validation at ReciBioPharm

Kailash Rathi is an experienced Validation and Quality professional with a demonstrated history of working in the Biopharmaceuticals industry for more than 14 years.

He is skilled in Validation activities, VMP, CSV,CAPA, Failure Mode and Effects Analysis (FMEA), Documentation, Root Cause Analysis, and Cleaning Validation.

Kailash is a strong quality assurance professional with a Master of Science (M.S.) focused in “Pharmaceutical Manufacturing Engineering” and Certificate in “Validation and Regulatory Affairs” from Stevens Institute of Technology.

About the Author

Lisa Wright, BA, GDL – Content Writer, Kneat

Lisa is an experienced writer whose work is focused on contextualizing the challenges and opportunities for validation, quality assurance, and compliance professionals operating in highly regulated industries. Outside of the office, she’s committed to education and has completed Kneat Academy End User and Power User 1 digital validation software training.