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Client: a well-known company operating in the engineering sector
Sector: engineering, food
Objective: To carry out an assessment against the 21 CFR part 11 regulation for the system for
controlling filling/packaging machines
As a company operating in the food sector and strictly subject to FDA regulations, the client was required to perform anaccurate evaluation of the computer system which controls its filling and packaging machines with the aim of implementing a modification of the system architecture while maintaining compliance with the requirements of current standards for IT systems.
To conduct this activity, the client company engaged an external partner with specific technical expertise and a deep understanding of FDA Regulation CFR 21 Part 11.
The client chose to entrust this activity to S4BT by virtue of our proven expertise in the development and validation of software applications for industries regulated by the FDA.
The work of the CSV Consultants was split into the following phases:
The Project has allowed the Client Company to increase its specific expertise on sector regulations and to lay the foundations for the development of a new control system capable of fully complying with current regulations on computer systems.
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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