25 Mar 2021

Quality Management System in OPIS

To ensure quality of performance and data OPIS has established a Quality Management System based on OPIS´ standard operating procedures (SOPs), and OPIS Policies. OPIS adheres to ICH/GCP, international and local laws and requirements, business ethics as well as standards and specifications which are related to the execution of operational processes.
The aim of quality management is to avoid bias of results by using an adequate data analysis, to assure authenticity, completeness and validity of the data and to identify and resolve deficiencies at an early stage.
Supervisory structures through all involved OPIS departments will insure, the OPIS work according to the applicable procedures and completely fulfill their contractual obligations. The same level of training and oversight will be applied to every team member within the OPIS team.
Our systems are ISO 9001 and 27001 compliant. Our in-house developed digital platform has been validated in accordance with FDA 21CFR part 11 requirements.

In 2018, the Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (‘GDPR’) came into force. OPIS has adopted all the proper measures to comply with the new law, also by updating its privacy policy and appointing a Data Protection Officer (‘DPO’).
A dedicated unit is responsible for ensuring staff and system adherence to the established Quality Management System based on OPIS standard operating procedures (SOPs) and OPIS Policies.

Quality Assurance as a service

The unit also provides the following services:

  • quality assurance for clinical trials
  • reference for ICH-GCP related issues
  • training content preparation and delivery
  • support in audit/inspection preparation at site
  • ad hoc quality activities in accordance with Sponsor requirement

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