CAPA & Backlog Management
CAPA management is at the beginning and the end of the loop to improve quality. (cf. PDCA Plan - Do - Check - Act ° from DEMING works). The monitoring of CAPAs and its follow-up is one of the main pharmaceutical processes audited by pharmaceutical inspections and internal examiners on the sites. Axys Network assists you
- To choose your priorities in the resolution and closure of CAPA according to GMP impacts
- To compile tasks and deliverables by grouping CAPAs for the same resolution of similar problems
- To create dashboards and key metrics
- To avoid declaring CAPA when there is a risk of duplicate tasks and responsibilities on the same subject.
- To present during inspections, a clear vision of the evolution of your stock and the actions in progress of your CAPA.
Deviation & Backlog Management
The deviations and anomalies management process must be based on a classification of the criticality of the anomalies (critical, major and minor) before investigating and defining the root causes. Axys Network assists you for:
- Determine root causes better and faster, avoid backlogs and close the investigation report in the allotted time
- To better segregate deviations and focus on the most important ones related to batch release and process stability
- Design simple and efficient dashboards as well as key indicators for monitoring the deviation process.
- Train and qualify fewer people quickly without impacting the implementation of the process
- To adapt the computer systems necessary for monitoring and managing process data to prevent human error
Other services
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