Are you sure your organisation is compliant with “GDPR” european law?
The GDPR GxpManager solution drives you through all the steps of the process required to be compliant and will help you to document all your actions.
Your needs
- Make an inventory, build your organization data registry process
- Identify your weak points and improve your process
- Inform the concerned person of your processing
- Allow them to use their rights
- Demonstrate your respect of the “GDPR” law
- Trace your actions
Our solutions
- A simple register to fulfill and consult compliance with the “GDPR”
- Integrated tool for risk analysis and corrections actions plans
- Audit trail
- Standard publication to document your compliance
FDA 21 CFR part 11
Access Management
You can create a profile for each user or group of users according to their access rights for features, databases, reading, writing, deleting or implementation.
Workflow
Monitoring levels of approval for data or test implementation made easier.
Tailored Regulatory Data Management for Medical Device Manufacturers
the importance of rigorously managing critical data for medical device manufacturers due to regulatory requirements. It highlights the limitations of office applications, such as spreadsheets, in ensuring data integrity and confidentiality. The concept of "Shadow IT" is introduced, emphasizing the need for compliance-oriented solutions. GxpManager offers an agile software solution, GxpApps Ultra-Agile, to address these challenges by integrating compliance features. The solution aims to provide a reliable and fast alternative to office files, enabling easy integration of critical data and supporting various regulatory constraints faced by different professions in the Life Sciences sector.
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