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Project Profile
Client
- Company based in Wallonia
Tools
- AVEVA OSI-PI
- SQL Server Reporting Services
Sartocheck 5 Plus to OSI-PI
THE MISSION of Asdaex
The Sartocheck 5 Plus is a piece of equipment from the SARTORIUS company which allows the integrity of filters used in pharmaceutical production to be tested. The objective of this project is to feed back the results of the filter tests and the audit trails emitted by this device to OSI-PI in order to archive the long-term data and to allow the generation of cycle reports and audit trail.
DESIGN
A complete study on the possibilities of connection with the device was carried out in collaboration with the company SARTORIUS (e.g. OPC UA, flat file). Tests were carried out to validate these different possibilities and make a final decision. An ERES assessment (Electronic Record & Electronic Signal) was also carried out in order to validate the conformity of the electronic data of the device.
SPECIFICATIONS
The entire project has been documented (e.g. Functional and detailed analysis, Installation guide) in order to meet GMP requirements.
DEVELOPMENT
The development consisted initially in defining configuration files for the OSI-PI connector allowing the analysis and archiving of the various data in OSI-PI.
QUALIFICATIONS
A central qualification was carried out in order to be able to replicate this integration more easily, and with less testing, during local deployments of devices (Risk mitigation).
SERVICES
- Computerized industrial systems
- Manufacturing Execution System
Our partners
Result
The integrity test results are fed back as well as the audit trail in real time. Operators can now use the various reports for their validation or investigation needs at any time and over any period.
Data integrity:
ERES compliance, from source data to long-term storage (Primary record).
OSI-PI:
Integration of equipment on OSI-Pi.
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