PRIMAS validated - Validated gauge management solution for medical and pharma

With PRIMAS validated you are on the safe side and fulfil all relevant normative requirements for test equipment monitoring and management from DIN EN ISO 13485, 21 CFR 820.72, ISO 9001, ISO 10012 and the EU GMP Guideline. The GMP-compliant validation package from Testo Industrial Services includes a compliance assessment for EU GMP guidelines Annex 11 and 21 CFR Part 11 and ensures the validated status throughout the entire system life cycle. The validation is carried out according to the specifications of GAMP 5®. Our industry-experienced validation team offers you the flexibility you need, the know-how for your validation project and the support with GxP-compliant validation documentation. Learn more about PRIMAS validated's risk-based validation.

To meet your high data security requirements, we take extensive measures. These include daily backups of your test equipment data and calibration certificates. The spatial and temporal mirroring of the data servers provides additional security. The unrestricted data sovereignty lies with you and Testo Industrial Services. PRIMAS validated guarantees you a secure system without data loss.

• Encryption of your certificates during transmission and at rest
• Role-based access control with granular permissions
• Extensive monitoring of access
• Regular vulnerability analysis by independent specialised security companies to ensure cyber resilience
• AI-supported monitoring of IT systems for anomalies
• DSVGO-compliant storage of your data within the EU

Thanks to the automatic documentation in audit trails, all quality-relevant processes and changes in the system are fully traceable. You always have an overview of which employee made changes in the system at what time. In addition, PRIMAS validated provides you with a comprehensive authorisation concept in which individual authorisation roles of your employees are defined. The assignment is carried out via an administration process, which ensures that authorisations are stored correctly. In the case of process-relevant changes and when releasing your test equipment, the additional password query forms a further security level.

Take advantage of our full-service offer for manufacturer-independent calibration of all your test equipment/measuring points. Automated and paperless processes in test equipment management and calibration increase the efficiency of your processes. In addition, Testo Industrial Services takes over the administrative tasks for you. We create new users during operation and assign access rights (write, read and certificate access) via the administration process in accordance with your previously contractually defined authorisation concept. In this way, you retain data sovereignty over setting, authorisation or mass changes and can be sure that changes are only implemented by authorised persons. The assumption of administrative tasks by Testo Industrial Services also makes it easier for you to implement the segregation of duties within your company without having to define additional roles yourself. You benefit from minimal administrative effort in the event of personnel or organisational changes in your company. Put user administration in the safe hands of Testo Industrial Services.

With PRIMAS validated you can clearly map your company structure with sub-organisations (e.g. different locations). Your employees can be assigned to the corresponding sub-organisations and thus, for example, be given the right to view and change master data only at the level of their sub-organisation. To monitor calibration and maintenance due dates, an escalation scenario defined by you is stored in the system. Here you can store up to four reminders with different escalation levels and ensure the timely calibration of your test equipment. Individual data reports give you an overview of all relevant information and the development of your test equipment at all times. For further tests in addition to calibration, you can easily book reminders for tests such as verifications or maintenance.

Integrate an unlimited number of gauges and users into PRIMAS validated quickly and easily. The system always adapts to your needs, regardless of how many gauges you want to manage.

In order to meet your requirements for an efficient and safe gauge management solution, new functionalities and minor changes are introduced into PRIMAS validated in an innovation cycle of 24 months at the earliest. All changes and innovations undergo a strict project planning and test phase, including a risk-based assessment. We ensure the revalidation of the system via our change management.

Test equipment status at a glance in the dashboard: Keep track of the due dates of your test equipment and plan your calibrations in good time. You can maintain the calibration interval manually yourself.

The escalation scenario function is a graphical representation of your escalation settings. The ‘Time control’ category visualises the monitoring periods that apply to your company. Depending on the due date that can be changed, you can check for which period the respective escalation level is active for you.

Based on the calibration results, you can use the new function to decide at the touch of a button whether the test equipment is suitable for the desired application. The individual release can only be carried out by authorised persons in accordance with your authorisation concept and is password-protected.

You can copy entire list entries from Excel, for example, and paste them into the expert search. You can use the global search to search all test equipment fields for individual keywords. Frequently performed searches can also be saved under your own search queries and executed at a later time directly from the start page - so you can find the relevant data quickly and reliably.

You can make changes to up to 300 devices within your test equipment lists by saving them once and entering a password. All changed data for all processed test equipment is applied at once. As usual, all changes can be traced in the field history via the audit trail.

Create a delivery note for the devices to be calibrated directly from PRIMAS validated with just a few clicks.

Avoid extra work due to incorrect test results and keep an eye on the measured values of your test equipment. With the additional tolerance utilization and measured value analysis functions in PRIMAS validated, you can easily and intuitively select and analyse your critical test equipment and its measured values. A forecast for the next calibration allows you to adjust the calibration cycle directly. This function can be added, but is not included in the validated scope. If you have any questions, please speak directly to your responsible contact person in the field.

Do you need further tests in addition to calibration? You can use this additional function to set reminders for verifications or maintenance, for example.