project

CSV/data integrity to rebuild the quality systems of a pharmaceutical site IS

Compliance Life Sciences France

Context and challenges

The customer is a pharmaceutical laboratory specializing in medical devices. One of its production sites is dedicated to R&D and to the manufacture of dermal filler substances based on hyaluronic acid. Faultless quality control and compliance with regulatory requirements are essential to preserve the excellent brand image of this type of injectable medical device and to maintain the regular growth of this strategic site.

In response to the new expectations for data integrity, this customer decided to optimize its quality system, in order to manage/control their IS/AS (Information Systems/Automatic Systems).

In this context, the customer has selected Assystem to help specify their data integrity remediation actions, train the members of the project team and optimize their entire quality system, to manage data and the information and automatic systems.

Project scope

  • Definition of the data integrity remediation project
  • CSV (Computer System Validation) and DI (Data Integrity) training: sharing of methods and common vocabulary with everyone involved in the project
  • Redraft of CSV-DI quality system procedures and directives for information and automatic systems:
    • Systems management procedure (roles and responsibilities)
    • Risk management, design, validation and operating directives
    • Standard templates and forms for support documents: UNS (User Need Specifications), risk analysis, test cards, SOP (Standard Operating Procedures), etc.
    • IT hardware and resources management procedure
  • Creation of a data integrity gap analysis form for existing systems

Client benefits

  • Appropriation of a data integrity culture through the provision of generic support documents, templates and forms that integrate the data integrity issue into all activities
  • Easy integration of new systems, through the integration of this approach from the start of the systems acquisition process
  • IT service structuring factor for integration into an overall quality action

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