PROJECTS

Implementation of a Workflow Manager to increase control

Client: company engaged in the research and development of innovative medicines for pain therapy and for the treatment of drug addiction for over 100 years.

Sector: Pharmaceuticals

Objective: to digitise quality processes with a workflow management system

Project

The client needed to computerise a number of strategic internal processes in the area of quality, CAPA, Deviations, Facility changes, Market complaints, Human Resources, Management of company SOPs, and Staff training.

After a careful review of providers, the client chose the specific experience offered by S4BT and its product, PRAGMA-WFM.

Implementation of PRAGMA-WFM

The Product Line work team conducted an in-depth study into the characteristics and needs of Molteni by analysing the client requirements (URS).

Once drafting of the URS was completed, the team worked on process design and configuration on the PRAGMA-WFM Platform.

For some processes, it was necessary to integrate PRAGMA-WFM and other pre-existing company systems.

The prototype was presented to the company during the configuration phase, as per S4BT standard practice.

Once the flows were designed, configured, and verified, the team took care of installation, first in the test environment and then in the production environment.

The work did not end with installation: the team also accompanied the client in the testing phase (UAT = User Acceptance Testing), in the drafting of the validation protocols, and in the training of personnel responsible for managing the system and of the end users.

The S4BT team supported Molteni during the configuration phase of the servers, backups, and system use environments.

Collaboration with the client company continues today: indeed, S4BT offers a Help Desk service in the daily use of the workflow system.

Result

By implementing the PRAGMA-WFM software, Molteni has obtained significant benefits, such as:

  • maintaining a control over workflows and documentation and managing them in real time;
  • simplifying and accelerating processes relating to Quality and Human Resources
  • providing immediate answers during the Inspection phase and having the peace of mind of a system that complies with European and American regulations and a team of professionals who have been operating in the pharmaceutical production industry for years
PRAGMA-WFM modules implemented by the customer
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Project

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Digitised processes
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Projects completed in 2019
CLIENT

Pharmaceutical Company

An international pharmaceutical organisation specialising in the clinical and commercial development and production of pharmaceutical products with a high degree of toxicity.

Home office

Digital Company

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Home office

Petshop Company

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PROBLEM

Conditioner Company

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retail office

Card Rental

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Home office

Expedition Company

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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