GLP / Quality Assurance
AROS employees are strongly committed to quality and reproducibility.
The staff has been trained in quality procedures, and AROS is from 2005
GLP approved by the Danish Medicines Agency.
Quality assurance and Regulatory compliance at AROS
AROS was GLP certified by the Danish Medicines Agency in 2005,
and is authorized to conduct pharmacological and toxicological
studies. AROS complies with 21 CFR Part 58 (USA), and OECD Principles
of GLP from 1998 (Europe). AROS Data and IT systems are compliant with
21 CFR part 11.
The certification of AROS was awarded after careful inspection
of AROS facilities. AROS has an advanced SOP (standard operating
procedure) system with close to 300 SOP´s covering all activities,
such as receiving samples, storage of samples, extraction of molecules,
robotic handling, labelling for microarrays, microarray analysis, storage
of data, file keeping, document handling, validation of equipments and
reagents, training of staff etc.
AROS staff is going through a comprehensive training program to obtain the competence needed. Annually the staff is following courses in quality assurance and an independent audit process is established.
AROS has used and continues to use significant resources on the Quality Assurance of all activities. AROS customers are most welcome to visit and inspect the facility.
For GLP compliant projects, AROS issues a report that includes all
SOP´s that were in use, equipment used, log files etc.