GDPR Consent: Legally Managing Data about EU Citizens

If you collect data in the European Union, you’re well aware of GDPR and potential for steep fines if you are not compliant. Find out which consent rules are key.

It’s been well over a year since the European Union’s (EU) General Data Protection Regulation (GDPR) went into effect. Proposed in 2012, the regulations were approved in 2016 to provide consistency between data privacy and protection regulations across EU member nations.

The cornerstone of GDPR is consent: information about a person belongs to that person. If your organization is collecting data thatin any way relates to a citizen of the EU, that person should be informed about how you plan to use that information and kept informed as your organization’s data management strategy evolves. It doesn’t matter where the individual is located — universities who have even one student who is a citizen of the EU must also comply.… Read more...

Regulatory Responsibilities in the Cloud

Core to the process of ensuring quality in products is the concept of validation. This is the process whereby manufacturers provide objective, documented evidence that their processes, equipment and computerized systems are checked and validated to ensure the quality of their offerings.

Central to the validation journey is the required documentation produced with each step. To satisfy regulators, companies must record evidence to prove what work was done and when, including elements such as designs, tests and test-script executions.

A new method for achieving this is gaining significant traction. Known as the Cloud model, it sees companies handing off various parts of the validation process to third-party (or Cloud) providers who, for a fee, handle them on their own information technology infrastructure.

Companies that move to the validation of their Quality Management System (QMS) to the Cloud are still responsible for meeting the same regulatory obligations as in traditional models. … Read more...

Documentation and Traceability: Ensuring Your Software is Doing What it Should

Software validation is at the heart of the Quality process. It’s the method by which manufacturers provide objective, documented evidence that their processes, equipment and computerized systems are checked and validated to ensure the quality of their final products.

Traditional on-premise validation of a Quality Management System (QMS) typically utilizes a “V Model” workflow. The process begins on the top left, with the left side defining a series of required deliverables. Once these are mapped out, you can configure and develop the system. Finally, as illustrated on the right arm of the model, the system is tested, with these actions being traced back to the previous planning stages.

The model helps organizations answer key questions about the project, such as:

  • What are you trying to accomplish?
  • What are the roles?
  • What documents are you going to generate?
  • Who approves them?
  • What process will you follow to develop this
Read more...