News and useful resources on Digital Transformation and Life Sciences
BLOG Digital Transformation: we have all heard these words at least once. Especially in recent months, in the light of the pandemic. Many companies are
According to ICH Q9, the benefits of risk management are to be achieved through the application of a QRM lifecycle.
BLOG The ALCOA principles are an important reference model in the pharmaceutical sector, and ensure the integrity of both printed and electronic data. Data Integrity
BLOG Quality Risk Management is a forecasting model and a systematic process for assessing, controlling, communicating and reviewing risks to the quality (understood as safety
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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