Roland Miksche, MiRo Consulting, Vienna, Austria
MS Excel is widely used in laboratories as well as in production. Excel spreadsheets are used in both larger and smaller companies for GxP-relevant applications. However, numerous risks with regard to data security result from the diverse and flexible application possibilities. If Excel is used in a GxP-regulated environment for quality-relevant tasks, special requirements must be met. Such Excel applications may easily come into focus in authority inspections.
But what exactly is necessary to use this powerful tool GxP-compliant and how to pass an Audit?
This webinar is aimed at all those responsible for Excel applications in the various departments (e.g. quality control, quality management, production, IT). These are, e.g. coworkers and high-level personnel from the following industries:
- Pharmaceutical companies
- API manufacturer
- GLP Laboratories
- other companies working according to GxP
Also addressed are employees of medical device manufacturers as well as of universities and research institutions who, for regulatory reasons, have to use Excel in a GxP-compliant way.
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
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 following topics are addressed:
- Areas of usage in the GxP environment
- Authority requirements and findings
- Spreadsheet categorization according to GAMP 5
- Life cycle model (from requirement to decommissioning)
- Presentation in the context of an audit
- Best practices from the pharmaceutical industry