PRAGMA-WFM

The web-based platform, FDA CFR 21 part 11 and cGXP Compliant,
for business process management.

PRAGMA-WFM

The web-based platform, FDA CFR 21 part 11 and cGXP Compliant,
for business process management.

digital transformation

Digitise your processes in total Compliance

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.

Respect for timelines
90%
Reduced approval times
95%
Reduced file closing times
90%
Reduced time in identifying causes of non-compliance
100%

3-solutions-in-1-platform

DIGITAL TRANSFORMATION

The strengths of PRAGMA-WFM

MODULAR AND SCALABLE

You can introduce any Module at low cost and with minimal impact, integrating it with existing Modules.

MULTIPLE-COMPANY-DEPARTMENT-PROCESS

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.

SYSTEMS INTEGRATION

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.

FDA CFR 21 PART 11 COMPLIANT

  • Electronic record management
  • Audit Trail (configurable)
  • Controls for closed/open systems
  • Electronic signature
  • Unique Reference signature/record
  • Identification code/password controls

PRAGMA-WFM in numbers

38 +
Facilities
5643 +
Users
37 +
Catalogue processes
193
Digitised processes
benefits

Why use PRAGMA-WFM

IT SIMPLIFIES

Fluid processes that adapt to the needs of your business.

IT CONNECTS AND BREAKS DOWN DISTANCES

A true Network between Companies, Departments, Systems, and Individuals. Anywhere.

IT PROVIDES OVERSIGHT

Control your processes, analyse data, manage delays, allocate tasks

it protects

It stores your data on a secure platform accessible only by authorised persons

It tracks

Choose the information you want to track. PRAGMA can get down into the smallest detail

It optimises

A digital map of all processes. Automation and simplicity

our clients

What our clients say

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COMPLAINTS

An aid to inspection work

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

AUDIT

Documents and traces activities

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