Efficient, traceable and scalable quality document management system. Kneat Gx allows you to manage effectively and efficiently the creation, collaboration, approval, and change to all controlled documents.

Kneat Gx Document Management

At the heart of every great quality organization is an efficient, traceable and scalable quality document management system. Being in the highly-regulated Life Sciences industry, you will need to quickly understand the health of your organization, through certification metrics and who is up to date with regulatory and corporate standards. Additionally, your user base will want a system that is intuitive and user friendly while still having a traditional look and feel. With the increase in regulatory, vendor and customer audits, Life Science organizations can no longer rely on a paper based or out dated document system as the solution.

Source: https://www.fda.gov/ICECI/EnforcementActions/ucm531890.htm

Next Generation Quality Document Management

The Kneat Gx platform allows for all types of quality documents to be authored, reviewed, approved and revised within the system. Once approved the training work flow will be initiated and each relevant employee will be certified based on meeting the specific pass criteria. Your training management process can be configured in Kneat Gx in accordance with your requirements. Management can view instant metrics on the status of training for all employees in real time. With the Kneat Gx platform your organization will have complete control of your document lifecycle and increased visibility through a validated, Part II/Annex II compliant solution.

Why Kneat Gx?

Many of the existing document management systems take months of training, achieve poor user adoption and require you to make significant changes to your process. We believe in allowing you to create your process in the system, instead of having the system build you a new one. Your process in the system is the founding principle of our platform, which is why many organizations see Kneat Software as a true partner for success and continuous improvement.

Change Control

Kneat Gx will allow your organization to have full control over the creation of new documents, revising of existing documents and the expiration of outdated documents. This robust change control is a universal feature of the Kneat Gx platform, that is leveraged across any process.
Document Authoring
Kneat Gx offers a unique feature for authoring directly within the solution, which allows greater insight and data integrity. You will no longer have to upload any documents and work outside of a non-validated solution. The authoring feature within Kneat Gx gives the user a rich formatting and creation tool that has a familiar look and feel of traditional “Office” applications.

Review & Collaboration

While document owners are creating or revising existing documents, they can invite others to collaborate in parallel. Document owners can send notifications for commenting and editing at any time.

Document Approval

Within the Kneat Gx platform there is a robust universal feature of approval groups that allows you to quickly select a group of required or requested approvers. Additionally, as these groups are typically setup in an 80/20 rule you will still have full flexibility of adjusting the groups in real time.

Training – Certification Sign-Off

Your training management process can be configured in Kneat Gx in accordance with your requirements. For example, once a new or modified procedure is approved the system will ensure that all those that require training will receive a request with a link to the procedure and a training record for completion and sign off with trainee’s electronic signature. In addition the training record can be configured to require the trainee to answer specific configurable test questions based on the procedure. The system will confirm a pass or request the trainee to take a retest. Management can view instant metrics on the status of training for all employees in real time.

Periodic Review

Periodic reviews can be setup for each document to alert the owner to a specific time period for review. This process allows your organization to stay up to date on reviewing documentation and ultimately greater compliance.

Metrics

Robust metrics and reporting is a key pillar of the Kneat Gx platform. You can track multiple metrics for each document through its entire lifecycle. You will see the document status in real time, approved, due/past due for review etc.
You will instantly be able to see the certified status for each employee against each of their training requirements. The system can be configured to escalate training needs if necessary. Leadership will understand the health of their organization, helping them to reduce document and process related events