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Client: well-known pharmaceutical multinational
Sector: Pharmaceuticals
Objective: To support the “Quality Assurance” department in the management of Process
Deviations, Change Control and CAPA (Corrective Actions Preventive Actions)
Due to a peak in workload, the client company needed specific support in the area of Quality Assurance to manage the following processes:
The project involved S4BT Consultants with proven experience in Quality Assurance acquired in a number of sectors, including chemical and microbiological.
After an initial analysis phase of the client’s business processes, part of Team focused on reducing process deviations already open, actively collaborating with the entire company organisation to obtain the necessary information and to process the related reports in accordance with internal client procedures.
The focus later shifted to new deviations.
By participating in the implementation of a targeted survey plan, through effective CAPAs, the team contributed to the achievement of two important objectives:
The resources involved in the management of Change Control and CAPA collaborated with the relevant departments for the following activities:
Already during the first phases of the project, the client company achieved two fundamental results:
The contribution of the S4BT Specialists in the management of Change Control and CAPA activities proved to be fundamental, making it possible to:
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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.
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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