Kneat Solutions

Every manufacturing process, every piece of equipment and every computer system involved in the manufacture of pharmaceutical and medical products must be validated in accordance with Good Manufacturing Practice (GMP) regulations.  Validation necessitates extensive documentary evidence that all aspects of these systems are designed and tested to ensure that they will repeatedly produce products to the approved specifications.  This documentation is subject to audit by global regulatory authorities such as the US Food and Drug Administration and the European Medicines Agency.


Traditionally validation is a paper intensive activity. Test documents must be developed, printed, approved, executed, post approved and filed away ready for audit.   Everything is done on paper using wet ink to record, apply signature and date etc.  It is a data and document minefield which leaves healthcare companies susceptible to negative patient outcomes, high costs and non-compliance.  Non-compliance can le