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BLOG Corrective and Preventive Actions (CAPA) are currently one of the major points of observation by the FDA. The management of CAPAs is complex and
BLOG Life Science companies are subject to frequent inspections by partners, agencies and authorities. For example, you may receive an inspection when you introduce new lines, produce
BLOG In companies that are highly regulated, such as Life Science, problems that impact quality need to be supported by robust and well-structured processes so
BLOG Can procedures impact the number of deviations? Deviations arise when unforeseen events or problems deviate from an approved GMP process and/or from what is required/accepted in
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Simplify the management of Complaints, from filing, through investigation, follow-up, judgment and final report.
The module is designed to provide step by step Quality Assurance support
in the implementation and supervision of the process and the assignment of tasks to the departments involved. The module supplements the CAPA procedure, which the user can open directly from the Complaints procedure.
PRAGMA-WFM documents and traces all activities and information in the Complaints process. In each phase, you can also attach files in various formats to support activities and investigations.
During inspection phases, the functionality dossier enables the real-time generation of a document that provides information and lists the activities of the process and related processes
It simplifies the management of internal and external audits, from planning, through execution, to the management of remarks.
The module supplements procedures for handling CAPAs , Non Conformitiesand Change Control that the user can open directly from the audit to resolve the observations found.
PRAGMA-WFM documents and traces all activities and information of the Audit process. For each process step, it is possible to assign tasks to the people involved, and attach files in various formats.
Duringthe inspection phase, the dossierfunctioncan generate a document in real time which records the information and activities of the Audits and related processes