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- Calibration
  
  We are one of the leading calibration laboratories in Germany and accredited for more than 300 calibration procedures according to DIN EN ISO/IEC 17025:2018.
  Calibration
- Our measured variables
  Our accredited laboratories cover almost all measurands and offer a unique service portfolio.
- On-site calibration
  We calibrate test equipment and measuring points at our customers' sites with professional competence and high-precision equipment.
- Calibration equipment
  With our portable calibrators for temperature, humidity and pressure, calibrations can be carried out regardless of location.
- Test equipment management
  
  We manage your test equipment with the holistic PRIMAS test equipment management solution for compliance with standards and directives.
  Test equipment management
- PRIMAS online & mobile
  The internet-based test equipment management system PRIMAS online supports the assurance of test equipment requirements - even while on the road.
- PRIMAS validated
  PRIMAS validated is a validation-enabled test equipment management system for companies with GxP compliance requirements.
- PRIMAS exchange
  PRIMAS exchange enables automated data transfer of test equipment data between MES/CAQ systems and our data master.
- PRIMAS connect
  PRIMAS connect is a web service for automated access and queries to PRIMAS online in the Testo Industrial Services data system.
- Qualification
  
  We support qualification projects such as cleanroom qualification or plant qualification. We also qualify warehouses and transport systems according to GDP and GSP standards.
  Qualification
- Cleanroom
  Professional support for all GMP measures in the area of cleanroom qualification - from conception to implementation.
- Plants & Utilities
  Risk-based qualification of process plants, supply systems and utilities for the sustainable safety of process stability and robustness.
- Transport and storage
  Storage and transport qualification to ensure uniform temperature and climate conditions and maintain product quality.
- Validation
  
  We take care of cleaning, process and transport validation as well as computer and software validation to ensure reproducibility and robustness.
  Validation
- Cleaning validation
  Holistic handling of professional cleaning validations as well as support for validation projects and revalidation measures.
- Process validation
  Risk-based process validation to demonstrate the fulfilment of process requirements and outcomes, and to ensure product quality.
- Transport validation
  Transport validation to ensure stable climate conditions during logistics and transport of sensitive goods to the consumer.
- Computer Software Validation
  Computer system validation and software validation (CSV) to ensure the reproducibility of procedures and processes of computer-based systems.

Validierung von computergestütztem Equipment

Der zweiteilige Fachartikel gibt einen detaillierten Einblick in die Qualifizierung und Validierung von computergestützten Stand-Alone-Systemen im GMP-Bereich. Beide Teile des Artikels erschienen 2020 in Ausgabe 3 und 4 der TechnoPharm.

Nutzung von Computern und Software in einem medizinischen Labor

In ihrem Beitrag erläutert die Autorin, wie wichtig es in pharmazeutischen GMP-Bereichen ist, ein übergeordnetes Konzept zur Validierung und Qualifizierung von computergestützten Stand-Alone-Systemen zu etablieren. Ziel dabei ist eine Standardisierung des Validierungsansatzes, der technischen Maßnahmen und der Validierungs- bzw. Life-Cycle-Dokumente. Zudem wird so die Integrität der mit dem Equipment erzeugten Daten unter Berücksichtigung der behördlichen Anforderungen sichergestellt.
Des Weiteren vermittelt die Autorin praktikable Lösungsansätze zur Erarbeitung und Implementierung eines solchen Validierungskonzeptes.
Dr. Susan Spiller ist Expertin für Qualifizierung & Validierung im GxP-Bereich und CSV-Beauftragte (Softwarevalidierung und Data Integrity) bei Testo Industrial Services.

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