During a kick-off meeting, validation approaches and documentation specifications are reviewed and mutually agreed upon. The design of the machine, its specifications and project risks are scrutinized and evaluated in a design review and then the framework determining the conditions of the IQ/OQ testing is laid out. Subsequently, specially trained technical authors edit the detailed test protocols and documents for each project in close cooperation with the customer:
During IQ, we document that the machine was installed according to what is specified by the DQ requirements and that all components, which are relevant for the operation of the machine, are present and meet their intended specifications.
Typical areas for IQ testing are:
Usually this IQ is executed at the customer's site, a modified process which executes IQ at Seidenader is optionally available.
After installation and site acceptance testing, the operational qualification has to prove in detailed tests, that all critical operation parameters are within the defined ranges. All testing is recorded and described in detail.
Seidenader Maschinenbau GmbH
85570 Markt Schwaben
P: +49 8121 802-0
F: +49 8121 802-100
Machine design and used materials comply with:
More than 115 years of experience in manufacturing pharmaceutical equipment
420 employees worldwide developing inspection solutions and vision systems for the pharmaceutical industry
275 track & trace installations by Seidenader, worldwide