Working alongside our customers for about 30 years. We achieve Business and Compliance goals together.
We are an organisation of over 80 specialists, with ISO 9001:2015 certification.
We’ve been providing specialised consulting and software solutions for the Life Science sector for over 30 years.
We help companies achieve their business and compliance goals in an ever-changing market.
PRAGMA4U is a web-based platform for the digitisation of business processes. It is 21 CFR Part 11-compliant and relies on the logic and functionality of the Workflow Management. It integrates with other systems, such as ERP, automates operations and reduces the possibility of errors.
PRAGMA4U has a specific mission:
“To optimise work activities and increase company performance”.
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