EASY UP AUDIT TRAIL REVIEW
P-Sorter is a reviewer designed to collect and compare analytics and audit trail data in every work area of a pharmaceutical company.
It is simple, intuitive and easy to use: this tool ensures that everything in the system has been reviewed, taking evidence of all controls and generating reports with GMP standards.
Its automation system architecture guarantees flexibility and expandability over time without affecting already automated processes.
Within P-Sorter there is no limit to the number of laboratory instruments: the user can select the type of instruments and insert or remove them completely independently.
KEY POINTS
- Review of all data received, and evidence of all checks performed
- Fast and low impact implementation, it’s easy to use and no instructions are required
- 95% of operator time saved checking data
- Processing of data manumission reports
- APP available on any device, with web server technology
- Data Integrity and CFR 21 Part 11 compliance
SUCCESS STORY IN TAKEDA
The most important aspects for Takeda have been:
- Being able to collect and compare analytical data and audit trails together
- Being able to ensure that the entire system has been examined
- Being able to highlight all the controls carried out in the process
- To achieve a fast and low impact implementation