Current Edition

PenThu® compliant with FDA 21 CFR part 11 and EU Annex 11

Gent, Belgium: 17th June, 2016 –  PenThu®, the first Interactive Guidance Management System (IGMS) in the clinical research industry developed by Europital, has reached a new milestone via fulfillment of critical regulatory requirements.
The safety of a computer system is reflected by the confidentiality, integrity, and availability of the system. Regulatory requirements define the criteria under which computerized system are considered trustworthy and reliable. The technical and procedural controls of a computer system are required to maintain the accuracy, integrity, and reliability of the data throughout the lifecycle of the records.
Documentary evidence is needed to demonstrate these controls are fit for purpose. Accordingly, the validation of a computer system must address the implementation and maintenance of the controls to enable integrity, including data entered manually and that automatically acquired in addition to the data processing.
Last May 5th, 2016 PenThu®, the Interactive Guidance Management System (IGMS) from Europital, was successfully audited for FDA 21 part 11 and EU Annex 11 compliancy by Ofni Systems, Raleigh, NC (USA).