Servicios de validación

Validación y cualificación para instrumentos de laboratorio y tecnología analítica de procesos

Un elemento esencial de los procesos de validación es la cualificación de los equipos y sistemas. Como fabricante de equipos de laboratorio y sistemas de análisis de procesos, en SCHMIDT + HAENSCH satisfacemos la enorme demanda de servicios de cualificación con un concepto integral. Obtenga documentación que respalde los requisitos reglamentarios y las normas del sector para el cumplimiento de los instrumentos.

Nuestro proceso de cualificación está diseñado para ahorrarle costes, recursos y tiempo en el proceso. Nuestros especialistas tienen años de experiencia en la cualificación de instrumentos de medida y conocen los requisitos reglamentarios actuales de las directivas, normas y leyes aplicables. Con nuestros servicios de cualificación de instrumentos, puede estar seguro de que sus instrumentos están instalados, funcionan y rinden de acuerdo con las especificaciones del fabricante y las normas internacionales como la conformidad con el 21 CFR parte 11, IQ, OQ, PQ o IPV y GLP / GMP.

Organic Certification Laboratory. Filling a Form for Organic Certification Procedure

21 CFR part 11 conformity is the recommended qualification variant for highly regulated, mostly pharmaceutical laboratories, also in some cases valid for cosmetics and food. Based on the standard qualification, further requirements are additionally covered, such as:

  • All necessary services and documents certifying and evaluating conformity with GAMP5 assessment, GMP, USP1058 as well as 21 CFR Part 11.
  • All necessary services and documents for a comprehensive DQ, IQ, OQ, PQ qualification requires
  • Pre-commissioning consultation, if required, as well as review, comment, and conformity assessment of the written DQ requirements in the customer’s specification document
  • All required documentation for risk analysis and risk-based documentation or hazard assessment
  • Review and documentation of software requirements using an understandable checklist
  • Comprehensive on-site SOP support and documentation
  • User training that includes the metrological methodology of operation and cleaning as well as the security aspects of audit trail, user management and data integrity.
  • All services covered in the standard license described above 

Since the requirements are always customer-specific, our team will check your specific User Requirements Specifications (URS) to ensure the 21 CFR Part 11 conformity for our product in your company. Together with the IQ, OQ, PQ, and software validation, the instrument will meet all pharmaceutical requirements.

Already during the development and manufacturing of SCHMIDT + HAENSCH instruments, attention is paid to compliance with Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP). All instruments are designed to ensure conformity to GLP and GMP during the whole lifespan of the instrument. To  maintain this status, service and support are carried out by our trained service experts and always documented in a GMP/GLP-conform way. Standard Qualification is a GMP/GLP compliant qualification of laboratory equipment at our customers’ site. Documentation includes: all necessary IQ, OQ, and PQ services in the working environment of our customers; all necessary documents, test protocols, and certificates; provision of all certified test equipment required for qualification, as well as measurement, control, and special tools; SOP support based on the requirements of the user and the measurement task; comprehensive application-related training of the operating personnel.

Installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ), or instrument performance verification (IPV) services verify and document your instrument’s ability to meet manufacturer design specifications for performance. All steps of this procedure are performed by trained engineers.

Software validation ensures that the software satisfies your customer-specific requirements. Documentation for software validity reduces the work required to integrate the new device into your system.

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