PenThu® Compliant with FDA 21 CFR Part 11 and EU Annex 11
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.
Ghent, Belgium, June 22, 2016 --(PR.com)-- 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).
About Europital
Europital is an international organization dedicated to Medical Management and Scientific Research. We provide our expertise in a flexible end-to-end model tailored for the business needs of our clients in the Pharmaceutical industry and Healthcare sector. Via our niche services and creative solutions, we support private companies and governmental institutes in achieving and maintaining high-quality and efficient work standards.
To know more about Europital, visit https://europital.com/
About PenThu®
PenThu® is the first Interactive Guidance Management System (IGMS) in the clinical research industry. It is an innovative approach from Europital that drives performance, knowledge and efficiencies via the creation of an interactive environment that provides the kind of transparency needed to share and access information in a way that really maximizes team performance and creates true partnership.
To know more about PenThu®, visit https://penthu.com/
Contact:
Europital BVBA
ICC Building, Van Rysselberghedreef 2
9000 Ghent, Belgium
Tel: +32 9 331 60 30
Fax: +32 9 329 55 48
Email: info@europital.com
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).
About Europital
Europital is an international organization dedicated to Medical Management and Scientific Research. We provide our expertise in a flexible end-to-end model tailored for the business needs of our clients in the Pharmaceutical industry and Healthcare sector. Via our niche services and creative solutions, we support private companies and governmental institutes in achieving and maintaining high-quality and efficient work standards.
To know more about Europital, visit https://europital.com/
About PenThu®
PenThu® is the first Interactive Guidance Management System (IGMS) in the clinical research industry. It is an innovative approach from Europital that drives performance, knowledge and efficiencies via the creation of an interactive environment that provides the kind of transparency needed to share and access information in a way that really maximizes team performance and creates true partnership.
To know more about PenThu®, visit https://penthu.com/
Contact:
Europital BVBA
ICC Building, Van Rysselberghedreef 2
9000 Ghent, Belgium
Tel: +32 9 331 60 30
Fax: +32 9 329 55 48
Email: info@europital.com
Contact
Europital BVBA
Patricia Piera
+3293316030
europital.com
Patricia Piera
+3293316030
europital.com
Contact
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