JUMO paperless recorder for FDA-compliant recording of process data in accordance with 21 CFR Part 11
Target group:
Employees who are responsible for startup, operation, and maintainance of JUMO paperless recorders for FDA-compliant data recording. Engineers as well as technicians who are responsible for planning plants with documentation requirements and who are responsible for their optimal deployment.
Objectives:
After the seminar the participants will be able to administer the system and to configure the paperless recorders for typical applications. Time-controlled communication via Ethernet can be set up using the communication software and the data of an archive can be evaluated.
Content:
The seminar provides central basic principles and information on the startup of paperless recorders and the relevant software components:
- Explanation of the safety concept for the whole system
- Installation of the PC software components
- Creating user lists and device rights files via the PC Security Manager software PCS
- Configuration of the paperless recorder using the setup program
- Electronic signatures on the device and on the PC
- Working with the PC evaluation software PCA3000
- Connection of the devices via RS485 and Ethernet interface, time-controlled data query with the PCA communication software PCC
- Traceability according to FDA 21 CFR Part 11 and introduction of the PC Audit Trail Manager software PCAT
- Practical session: extensive workshops on the device as well as with the software components
Prerequisites:
Basic technical knowledge.
Trainer:
Manfred Walter
Product Management Recording/Transmitter/SPE
Manfred Schleicher
Trainer Sensor and Automation Technology
Booking Number:
JK 706560