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Frequently Asked Questions

Can we integrate our ERP system to Kneat?

Yes any ERP system such as SAP can be easily integrated to the Kneat platform based on client requirements. Kneat has been developed using the best of breed Microsoft.NET technologies so integration on any level can be easily achieved.

Can we integrate to other pieces of equipment?

As mentioned the Kneat platform has been developed using the best of breed Microsoft.NET technologies so integration can be achieved based on the clients user requirements.

Does the Audit Trail comply with 21 CFR Part 11?

Absolutely, the Kneat system has been developed closely in association with the 21 CFR Part 11 regulations and the EU equivalent Annex 11. We have a 21 CFR Technical Control document that can be reviewed at any time.

Can we use Kneat for CAPA and Complaints Management?

Kneat is 100% configurable so it is very easy to set up the system to allow CAPA or Complaints. A big advantage of Kneat is the ability to associate the CAPA or Complaint directly with the batch or lot in question.

Can we use Kneat for submissions to regulatory authorities?

Due to the 100% configurable nature of Kneat, the style and structure of reports or documents for submission can be structured into the exact format required. This will dramatically reduce the submission time.

Will you be able to support use fully?

We guarantee 24/7 help desk support to ensure business continuity.

Can two of more people work on the system at the same time?

Kneat has been developed to offer a collaborative environment where users can work in the same document at the same time. So for example if you are executing a batch record of a validation protocol someone could be filling information in section 2.0 while the other person fills in information in section 4.0.

Can documents be converted to Word and PDF format?

All documents can be converted to the MS Word or Adobe PDF format.

Has Kneat got their own Quality Management System (QMS)?

Yes we have an extremely comprehensive QMS developed closely in association with the guidelines contained in GAMP 5 that can be audited at any time.

Does Kneat offer validation support?

Yes we offer validation support for both on-site and cloud deployments.

How does Kneat help with GxP compliance?

Kneat takes care of all GxP compliance so that you will have a free flow of creation, approval, storage, use, review and archival of all data that is generated by R&D, clinical production, post pilot data and manufacturing and validation processes.

What do I need to access Kneat?

Kneat is a web application (client/server). You interface with the system via your web browser from any PC. No software resides on your PC.

How many people can login at the same time?

The Kneat application has been profiled and optimised to allow an unlimited number of people to logon concurrently within your organisation.

How long will it take to get trained on the system?

Typically a power user can be trained in 2 days, a general user can be trained in 0.5 day.

Can I upload templates directly or do I need to configure them into Kneat?

Templates cannot be imported directly but all text can be copied into Kneat documents very easily, leaving just the intelligent tables to be configured. We also offer a full service where Kneat Engineers will configure the templates for you into the application.

Does Kneat contain different modules?

Kneat is 100% configurable; it does not contain different modules. It is one single platform on which you can configure many solutions.

Do we have to change our processes to suit Kneat?

The big advantage to using Kneat relative to other applications is that it is 100% configurable to your business processes; you can map your process exactly in Kneat which means very low disruption to your current processes and personnel.

How does your license agreement work?

We offer both concurrent and named licenses as part of our user agreement. For Kneat Manufacturing we advise companies to go with the named user license agreement so that all personnel associated with manufacturing have system access at all times.

Does this product come with biometric access permissions?

Currently we do not have biometric access as part of system entry. However our system has all of the user and access permissions required to ensure 21 CFR Part 11 compliance.

How can we use this system on the product floor?

Kneat can be accessed from any device with a web browser, so depending on what zone you are working in Kneat can be accessed using a PC terminal or any approved laptop for that designated area.

Will auditors accept this system?

Yes, auditors will accept this system because it helps to achieve consistent quality, cGMP compliance and it complies with FDA regulation 21 CFR Part 11 governing electronic records and signatures.

Is it possible use a mobile device /Tablet PC for mobility to allow flexibility for an operator to run a machine and control E-BMR?

Yes. The choice of mobile or remote workstations depends on the classification of the area. The Kneat System is compatible with any portable device which can operate a web browser.

Can an authorized person or a QA person sign off from a remote place?

Yes, any person with the correct permissions can input data and signoff remotely from any PC in your organisation.

Does this solution support Microsoft Active Directory user administration?

Yes.

Does Kneat support E-Signatures?

Yes Kneat has all of the controls necessary for 21 CFR Part 11 and Annex 11 compliance and has the ability to apply electronic signatures in accordance to any predicate rule.

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