GxpManager’s application for risk analysis allows you to manage all your procedures for risk management and automatically publishes the risk management file: identification, evaluation, control, acceptability, report…..we ensure complete control of your risk analysis in full compliance with standards applicable Gamp5, FDA, ISO 14971…
This application is suited to risk analysis procedures within the medical and pharmaceutical industry (AMDEC, Criticality, ISO: 14971…).
All our applications are based on a range of powerful functionalities that are compliance oriented (21 CFR Part 11, traceability matrices, reporting and automatic publishing,…) and can be easily connected to our regulatory database monitoring platform (fragmented regulatory texts available in the Regulatory Database, and regulatory watch ).
- Capitalising on your risk analysis (identifying hazards…)
- Drawing up rules for scaling and controlling your risks
- Assessing efficiency of measures for risk control
- Monitoring KPIs drawn up to help you with decision making.
- Reducing time spent on document management (technical files…)
- Centralising and sharing data (check-lists, hazards, measures for risk control, rules…)
- Automated process for scaling and controlling hazards (scales, aversion matrix, level and type of risk)
- Reporting in real time (dashboards, KPI monitoring….)
- The risk management file is automatically published