Kneat Manufacturing™ is the most flexible approach to paperless manufacturing yet. It delivers a large proportion of MES benefits with almost no disruption and for a fraction of the cost.
Kneat Manufacturing has all of the management documentation functionality required for regulated manufacturing in a simple affordable FDA compliant system.
The Kneat platform allows companies to build solutions around their business processes by using our 100% configurable software.
Kneat Manufacturing has been designed to simplify the documentation processes associated with manufacturing and batch production.
Kneat is a natural alternative for manufacturing companies who are using MS Word and Excel generated paper documents to record elements of their manufacturing processes.
One Version of the Truth
A key feature of Kneat is not only can the batch or device history record be automatically generated on creation of the batch or lot number, but all associated forms from bill of materials, inventory requests, specifications, QC inspections, etc, can also be created at the same time so that they are available and easily accessed by operations personnel when required.
Instantiate All Related Batch Records
Once a new batch number is created in the Batch Number Assignment Form, the master manufacturing records are instantiated and all associated records for that batch are generated in one secure location
Removing the paper and putting your production process online means that management can now have full visibility on the progress of all production lots in real time without having to enter the production environment.
Non-conformances can be flagged and dealt with in real time, reducing delays and improving the use of resources.
No More Paper Chasing
Electronic work flow processes mean that the approval of a batch for release is now a collaborative process, gone are the days of chasing paper. Retrieval of critical records is only a button click away.
Customizations create a legacy problem when upgrading to newer system versions, because at least a part of the customizations will have to be re-implemented in the new version, creating cost in terms of development, testing, and re-validation.
Kneat’s .NET platform is 100% configurable ensuring no custom code or bespoke development is required
Part 11 & Annex 11 Ready
The Kneat.net platform conforms to compliance standards such as FDA’s 21 CFR part 11 (for electronic records and signatures) and EU’s Annex 11. Users of the Kneat Gx application can rest assured that their data is fully protected according to the regulatory requirements.
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