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.