CAPA Deviation and Actions Management

: CAPA-Solution(click to enlarge)

CompliantPro™

The IBS CAPA system supports you in the continuous improvement of the quality of your products and processes, in increasing customer satisfaction and fulfilling ISO and FDA requirements.

CompliantPro™ CAPA assists with the documentation of all product and process deviations, defects and complaints and the analysis thereof. The CAPA workflow is a closed control loop and can be adapted to suit your processes. Actions planning can be used to launch immediate actions and long-term corrective actions, analyzed in terms of root-cause, prior to implementation and finally subjected to an effectiveness check. From hereon further actions can be launched, such as preventative actions, either dependently or independently of other processes.

Benefits at a glance:

Actions can be launched directly from customer complaints, deviations, risk analyses and environmental events. A reference link to the origin of the action is contained in the correction plan.
Enables specific task control thanks to automated workflows
Master data such as the product, customer or supplier serve as sources of information and enable a quick evaluation.
Individual deadline planning is integrated for each action, as are also the status and the handler.
It is possible to create several different templates (e.g. with different workflows) for the action plans
Fulfills the requirements of FDA 21 CFR Part 11, in particular those pertaining to electronic data records and second password
Full documentation with change history and Audit Trail
High degree of reliability / scalability thanks to role concept
Document Control is integrated in other CompliantPro™ components, such as CAPA, Change Management, Audits, Risk Management, etc.

Additional Features:

Web-based system
Defined input forms and workflows
Status administration, deadline administration
Integrated escalation management and deputy rules
Linkage to other relevant documents and external documentation
Comprehensive search and reporting functions
Multilingualism
Reliability thanks to role concept
Regulatory Compliance

IBS:infopool

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Dokumente wählen

- MAPA - CAQ in the Field of Medical Technology

- Loehr - High precision in the metal industry

- Rees - IBS:MES in the Metal Processing Industry

- Excellent production management with IBS:prisma

- Excellent quality management with CAQ=QSYS® Professional

Case Studies
- MAPA - CAQ in the Field of Medical Technology
  Dateigröße
- Loehr - High precision in the metal industry
  Dateigröße
- Rees - IBS:MES in the Metal Processing Industry
  Dateigröße
Brochures
- Excellent production management with IBS:prisma Dateigröße
- Excellent quality management with CAQ=QSYS® Professional Dateigröße