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Client: a company that has always been involved in the research, development and marketing of innovative medicines.
Sector: Pharmaceuticals
Objective: to improve and optimise the flow of issuing Certificates of Analysis
The purpose of the Project was to improve and optimise the flow of issuing Certificates of Analysis relating to finished products, raw materials, and primary packaging materials. The client company decided to introduce new software to manage the creation, revision, and approval of the Certificate itself.
The work of the S4BT Consultant was split into two macro-activities:
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Pharmaceutical Company
An international pharmaceutical organisation specialising in the clinical and commercial development and production of pharmaceutical products with a high degree of toxicity.
Digital Company
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Petshop Company
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Conditioner Company
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Card Rental
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Expedition Company
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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