Validated test equipment management in medical technology - from PRIMAS online to PRIMAS validated
Since 2009, Richard Wolf GmbH has been using PRIMAS online to manage its more than 4,000 pieces of test equipment. Since regulatory requirements meanwhile demand the use of a validated test equipment management system, an uncomplicated and quick changeover to PRIMAS validated was to take place.
The products of Richard Wolf GmbH are known for their quality. It is not without reason that the company has earned its place at the forefront of endoscopic diagnosis and therapy in human and veterinary medicine over the past 100 years. Professional test equipment management is an important cornerstone for ensuring and guaranteeing product quality. The company previously used the PRIMAS online IT solution, which was individually tailored to its needs and covers the complete process of test equipment management: calibration, organization and documentation.
Due to regulatory requirements of 21 CFR part 820 and ISO 13485, it was necessary to switch to the validatable and thus audit-proof software solution from PRIMAS. Testo Industrial Services implemented this change to PRIMAS validated smoothly during operation.
Since we already had very good experiences with PRIMAS online, the decision to switch to PRIMAS validated was made relatively quickly. In the course of the changeover, we checked our complete data stock and were thus able to improve our data quality even further. Another big advantage was that the entire project flow was already outlined by Testo Industrial Services. In addition, we were able to fall back on a comprehensible guideline and the entire validation documents were available to us. Thus, due to the good preparation, the execution of the validation was completed in 3 days. The cooperation during the whole project ran smoothly and in case of queries we always had a contact person at our disposal. The processes and workflows optimized by PRIMAS validated let us work more securely regarding audits, but also regarding our own data management of more than 4,000 test devices.
Tobias Schaefer
Responsible for test equipment management
Richard Wolf GmbH
Your advantage: Our competence
- Fully comprehensive validation service: Standardized validation concept supplemented by user-specific configurations including GxP-compliant validation documentation
- Safety: Ensuring the validated state over the entire system lifecycle of PRIMAS validated.
- Comprehensive support: validation know-how throughout the process reorganization
- Efficient partnership: Smooth process and low effort due to close cooperation and competent project management
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Test equipment management with PRIMAS
Holistic test equipment management solution with many pragmatic modules
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