Audit Readiness

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:

1. • 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:

1. • 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:

1. • 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