Kneat Gx | Audit Readiness
Audits and inspections are a fact of life for companies in highly regulated industries. Every document must be ready to withstand regulatory scrutiny, or companies risk the consequences. Kneat Gx makes it easy to be audit ready, any time, by integrating compliant validation data into every step of the production lifecycle.
Dependable Data Integrity
21 CFR Part 11/Annex 11 data integrity requirements are a key aspect of audits and inspections facing life sciences and similar industries. Kneat Gx cements data integrity into all aspects of validation, regardless of stage, requirement, and process.
Key data integrity features include:
- Role-based user access controls
- Time-stamped audit trails
- Password-protected electronic signatures
- Integrated exceptions management
Streamlined Audit Preparation
Auditors can ask nearly any question that comes to mind and it’s your job to provide not only an answer, but documentation that proves it. Data accessibility is key to a successful audit, and Kneat Gx makes it easy and completely paperless.
Using Collections, Kneat Gx users can:
- Send approved documents to a staging area, acting as a virtual “War Room”
- Assign non-standard users, such as auditors, access to Kneat Gx to view validation documents, non-GxP documents, drawings, and more
- Easily show auditors, external stakeholders, and others how to use Kneat Gx to continue their reviews
Comprehensive Digital Validation
Kneat Gx handles every validation requirement and brings together validation data and documentation, non-validation documentation, drawings, and more under one secure, easy-to-use platform.
Kneat’s digital validation platform helps prepare for audits by:
- Enabling online text execution, globally remote review/approval, and automatic requirements traceability matrixing.
- Leveraging document templates and seamless data transfer between documents to reduce human error
- Providing real time validation status updates, visibility, and reporting
- Eliminating manual document handling, printing, storage, and retrieval to save time and ensure documents are always available when you need them
Transforming Traceability: From Prohibitive to Productive Risk Mitigation
The customer, a rapidly expanding biotechnology company with over 45,000 employees achieved an 88% time saving on C&Q activities, reducing the cycle time from two months to just seven days with Kneat Gx.
Other Applications
Use Kneat to manage any validation, commissioning or qualification process.
Contact
Talk to us
Find out how Kneat can make your validation easier, faster, and smarter.
Start your paperless validation revolution by speaking to our experts.