Validation concept for PRIMAS validated

Initial validation

PRIMAS validated is a validatable test equipment management system whose functionalities can be individually adapted to your requirements. Therefore, the validation includes both the systemic basis and its functions (such as audit trails and certificate histories), as well as your customer specific configurations (such as the escalation scenario and the authorization concept). For the validation of PRIMAS validated we offer you a fully comprehensive validation service, consisting of a standardized validation concept supplemented by your user-specific configurations.

As part of our validation activities, we have subjected the systemic basis to comprehensive GAMP®-based risk management and implemented organizational and technical measures derived from this. The correct functionality was confirmed by extensive testing as part of the installation and functional qualification. A summary validation report documents all validation activities and provides you with additional security vis-à-vis the authorities in the event of an audit. The validation package is provided by the Validation of your user specific configurations. Our validation team creates the appropriate validation and test documents and adapts them to your configurations. The execution of the specified validation tests and their documentation is carried out by you or our validation support.

Change Management

In order to meet your requirements for an efficient and secure test equipment management solution, new functionalities are only introduced into PRIMAS validated in an innovation cycle of 24 months at the earliest, in the form of update packages. All changes and innovations go through a strict project planning and test phase and are already successfully used by users of the established PRIMAS online. We ensure the revalidation of the system via our change management.

We will inform you about the implementation date and the planned changes in good time before the update is published. In addition, depending on the scope of the changes, we provide you with validation documents with the necessary test documents, which you can integrate into your change management on site. With our uncomplicated revalidation services you benefit from a safe and controlled further development of your validated test equipment management system.

Your validation expert

Take advantage of my many years of experience in the implementation, conceptual design and coordination of validations/qualifications of computer-aided systems. For your questions around the validation of PRIMAS validated I am at your disposal - please contact me.

Dr. Susan Spiller

Expert for computer and software validation

sspiller@testotis.de