Prepare for GDPR

GDPR Readiness with Sparta Systems

With the General Data Protection Regulation (GDPR) now effective, Sparta Systems’ cloud solutions are  GDPR-ready so that customers can use our solutions as the meet both 21 CFR Part 11 and GDPR requirements. At Sparta Systems, our products are already built with “Data protection by design and by default”, or Privacy by Design (PbD), to help comply with this new regulation. We have built our systems to comply with the Title 21 CFR Part 11 and its associated rules around data integrity and data security.

GDPR’s Impact to Global Companies

The GDPR was designed to harmonize data privacy laws and regulations throughout the EU and member states, enhance data protection for EU citizens and to reshape the way all organizations approach data privacy. The GDPR covers the personal data of every EU (and member state) person and provides comprehensive rights to those data subjects. Every company that works with European employees, customers and partners will need to comply with the regulation. Failure to meet the GDPR requirements can result in fines up to EUR 20 million or up to 4% of the company’s worldwide annual turnover for the preceding fiscal year, whichever is higher.

Sign Your DPA

Sparta makes it easy for our customers to formalize and share with their stakeholders, including employees, customers and potential auditors, that they use Sparta Systems’ solutions in a way that meets GDPR data processing obligations. The Data Protection Agreement (DPA), pre-signed by Sparta, is a self-serve and easy-to-execute document that only requires an electronic signature from the customer.

After you execute the DPA, it needs to be returned to Sparta Systems, and if accurately completed, the DPA will then become legally binding. We'll communicate with you in the event of any issues. Send the document (or request it to be routed to you via DocuSign) to GDPR@spartasystems.com.

DPA - TrackWise Digital
DPA - TrackWiseDigital - Document Management
DPA - TrackWise Digital - FDA Gateway
DPA - TrackWise Supplier Collaboration

Sparta Systems and Privacy Shield

Sparta Systems is also Privacy Shield certified. Having the E.U.-U.S. Privacy Shield and the Swiss-U.S. Privacy Shield Frameworks provide legally recognized ways to transfer data across European borders.
Please see our Privacy Shield / GDPR statement for additional details:

Privacy Shield/GDPR Statement

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