Validation Services

Validation and qualification for laboratory instruments and process analytical technology

An essential element of validation processes is the qualification of equipment and systems. As a manufacturer of laboratory equipment and process analytical systems, we at SCHMIDT + HAENSCH meet the enormous demand for qualification services with a holistic concept. Get documentation that support regulatory requirements and industry standards for instrument compliance.

Our qualification process is designed to save you costs, resources and time in the process. Our specialists have years of experience in the qualification of measuring instruments and know the current regulatory requirements of the applicable directives, standards, and laws. With our instrument qualification services, you can be confident that your instruments are installed, operating, and performing according to manufacturer’s specifications and international standards such as 21 CFR Part 11 conformity, IQ, OQ, PQ or IPV and GLP/GMP.

Organic Certification Laboratory. Filling a Form for Organic Certification Procedure
21 CFR Part 11 sets out a number of criteria by which electronic records, electronic signatures and handwritten signatures on electronic records are assessed for their trustworthiness, reliability and equivalence to paper documents or paper signatures. The requirements apply to data that are created, modified, stored or transmitted electronically and that are intended to be available for inspection, verification or copying. The Directive also makes a distinction between open and closed systems.

SCHMIDT + HAENSCH offers the fully 21 CFR Part 11 compliant Aquisys 3 software as an integrated part of the VariFamily instruments – VariPol polarimeter, VariRef refractometer and VariDens density meter.The software is able to handle extensive data storage and create a detailed audit trail on the instrument in a correctly deployed IT infrastructure. User management, a validation process and password protection are all part of Aquisys 3. All measurements are stored in an encrypted database and protected against data manipulation. Statistical evaluations of the results on the device are possible, as well as comfortable and individual report creation and export.

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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