Processing of CAPA & Deviations Backlogs

Axys-Network offers two services:

The overhaul of your Deviation and CAPA processes

Backlog handling by experienced consultants

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 

Take advantage of experienced experts and benefit from their experience

Human Error Prevention