PROJECTS

Implementation of a Workflow Manager to boost productivity

Client: an international pharmaceutical contract manufacturer specialising in the clinical and commercial development and production of pharmaceutical products with a high degree of toxicity.

Sector: Pharmaceutical

Objective: to computerise strategic internal processes

Project

The client company, an international pharmaceutical contract manufacturer specialising in the clinical and commercial development and production of pharmaceutical products with a high degree of toxicity, required a solution that would allow its management to:

  • computerise strategic internal processes
  • perform an accurate check
  • optimise the use of resources
  • eliminate rejects and errors

A long selection process led to the choice of PRAGMA-WFM ,thanks to which the client was able to manage processes in the following areas automatically:

  • Production: management of calibrations and revalidations and the respective deadlines
  • Quality: management of company SOPs and Personnel Training
  • IT: management of user profile assignment by group

The implementation of PRAGMA-WFM

The Product Line work team designed a software solution perfectly tailored to the Client’s requirements throughthe analysis and drafting of the document summarising the requirements (URS).

Subsequently, in agreement with the client, the team focussed on process design and configuration on the PRAGMA-WFM platform.

In the next phase, the Product Line Team Installed the PRAGMA-WFM version at the pharmaceutical company, first of all in a test environment, in which the Client was able to conduct a formal verification, then in the production environment.

S4BT’s work was not finished with the installation. The Team also assisted the Client in theTest phase (UAT = User Acceptance Test), for the drafting and execution of the Validation Protocols , and implemented Training Programmes for the staff assigned to managing the system as well as for end users.

The S4BT team guided the Customer during the Server Configuration, Backup and System Usage Environment phases, and provided support during the initial data upload.

The co-operation with the Client company continues today: S4BT provides the Help-Desk service in the daily use of the system.

Result

Implementing the PRAGMA-WFM software has given the Client important benefits, such as:

  • keeping workflows and documentation under control and managing them in real time;
  • simplifying and speeding up processes;
  • being able to provide immediate answers during inspections.

All this has led to:

  • Savings in time and costs
  • Optimisation of resources with the confidence of relying on a System compliant with European (Eudralex Vol. 4 – GMP guidelines to Good Manufacturing Practices, Medicinal Products for Human and Veterinary Use-Annex 11 Computerised Systems) and American (US FDA-21 CFR Part 11: Electronic Records; Electronic Signatures) standards, and a team of professionals who have been working in the field of pharmaceutical production for years.
PRAGMA-WFM modules implemented by the customer
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Project

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Projects completed in 2019
CLIENT

Pharmaceutical Company

An international pharmaceutical contract manufacturer 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