Dr Timo Kretzschmar, anapur AG Region Wien
Computerised systems have continuously developed over the years as an “omnipresent companion” in the GxP landscape. It is not a “clearly representable” area, but an inherent dimension in the entire GxP with a rapidly growing influence on drug safety.
As practical difficulties in the classification and treatment of computerised systems reveal, they are sometimes difficult to “separate” from their environment, can only be grasped in their entirety and thus be identified as GxP-relevant in the given case.
Computerised systems include a wide variety of forms of appearance, e.g.:
- Excel spreadsheets (with formulas)
- Production-supporting software without sensors / actuators via (individual) controls of production equipment
- complex process control systems
- broadly based cloud systems of global organisations
In order to use resources carefully, it is advisable to use audits to illuminate this jungle of possibilities with the „glasses of compliance“ before actions are taken.
The focus of this webinar is on the target-oriented use of audits to achieve compliance with legal and operational requirements. This works best accompanied by the practical, continuous improvement and development of the ability to distinguish the necessary from cosmetic issues. This prevents audits from becoming formal activities.
The webinar is aimed at managers from all areas of quality, automation, IT and technology, who, as auditors or auditees, have to deal with computerised systems / data integrity with regard to the preparation, implementation and / or follow-up of internal / external audits and official inspections.
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
The aim of the webinar is to make better accessible issues that arise in practice around audits, such as:
- Computerised systems – a new aspect in the compliance landscape?
- What are computerised systems from an auditor’s perspective?
- Are computerised systems “formalised” auditable / inspectable?
- What do audits / inspections reveal and what do they sharpen your eyes on?
- How does understanding for the compliance of computerised systems arise?
- Compliance, a necessary evil or a tool for controlling costs?