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PROJECTS

Assessment of the control system for filling/packaging machines

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

Project

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.

Our contribution

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:

  • provision of two training sessions: one related to FDA 21 CFR part 11 and one introducing the GAMP 5 guidelines.
  • execution of a control system assessment for the filling and packaging machines, through the inspection of all technical documentation and targeted interviews with key users of the automation and aseptic technology departments
  • drafting of an Assessment Report identifying the gaps (with respect to FDA regulations) of the new control system under development

Result

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.

CONSULTANCY SERVICES PURCHASED BY THE CLIENT COMPANY
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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.

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