- + 39 0773.694245
- Mon → Fri: 9.00 a.m. – 5.00 p.m.
- marketing@s4bt.it
Menu
The web-based platform, FDA CFR 21 part 11 and cGXP Compliant,
for business process management.
The web-based platform, FDA CFR 21 part 11 and cGXP Compliant,
for business process management.
PRAGMA-WFM is a web-based platform for business workflow management. The platform uses the logic and functionality of Workflow Management.
PRAGMA-WFM has a specific mission:
“To optimise work activities by increasing the performance of companies, guaranteeing full governance and traceability”.
The platform was created in 2001 within the pharmaceutical industry with the capacity to respect its rigorous quality standards.
PRAGMA-WFM is CFR 21 part 11 Compliant and a particularly valuable tool in the inspection phase. It tracks even the smallest level of information, selectively archives data, and creates detailed, comprehensive reports.
You can introduce any Module at low cost and with minimal impact, integrating it with existing Modules.
PRAGMA can manage multiple processes, even when connected to each other (Quality Management System). Processes can be shared with multiple departments and multiple companies, both within the Group and with third-party companies.
PRAGMA integrates with any system that is ready for data sharing. It automatically captures information, reducing manual input and the potential for error. Data are updated in real time for quick and easy work activities.
Fluid processes that adapt to the needs of your business.
A true Network between Companies, Departments, Systems, and Individuals. Anywhere.
Control your processes, analyse data, manage delays, allocate tasks
It stores your data on a secure platform accessible only by authorised persons
Choose the information you want to track. PRAGMA can get down into the smallest detail
A digital map of all processes. Automation and simplicity
TOGETHER IS BETTER.
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