Company  »  Quality and Security

Quality & Security

Pharmacelsus attaches great importance to quality and security. The facility is equipped with state-of-the art safety arrangements. Additionally, all studies are performed in a GLP environment to guarantee reliable and secured data for the customers.

 

glp

GLP certification

In 2008, Pharmacelsus was included in the national GLP Compliance Program and is inspected on a regular basis.

The areas of expertise, according to OECD guidance are:

  • (2) toxicity studies
  • (8) analytical and clinical chemistry testing
  • (9) other (pharmacodynamic, pharmacokinetic, metabolic and toxicological testing)

All assays (GLP- and Non-GLP studies) will be carried out in a certified GLP-conform test facility and in compliance with all applicable GLP guidelines. (GLP certificate)

 

Quality Management System

Pharmacelsus has implemented a comprehensive quality management system responsible for internal audits, SOP and document management, and continuous employee qualification.

 

Biometric Access Control

The Pharmacelsus test facility is equipped with state-of-the-art biometrical access control systems.

 

IT Security

IT security audits are carried out by external experts on a regular basis.

 

Electronic Data

Electronic data capturing and storage is secured by continuously updated hardware and software including firewalls, antivirus-software and RAID-Systems. According to the Pharmacelsus backup strategy, data backups are carried out on a regular basis in short intervals allowing for a secure preservation of all data generated. The transfer of electronic data to the customers can be accomplished either via e-mail or through a secure web space with SSL encryption.

All communication and data transfers can optionally be done encrypted. We suggest using GPG – an OpenPGP-compliant encryption system.