DQ / IQ / OQ
DQ - Design Qualification
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:
- Functional Specification (FS)
- Hardware Design Specification (HDS)
- Software Design Specification (SDS)
IQ - Installation Qualification
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:
- components critical to the process
- controls systems and loops
- change parts
- PC and PLC hardware
- utility connections
- loop tests
Usually this IQ is executed at the customer's site, a modified process which executes IQ at Seidenader is optionally available.
OQ - Operational Qualification
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.
- Safety functions
- Machine functions
- Operator interface
Seidenader Maschinenbau GmbH
Lilienthalstr. 8
85570 Markt Schwaben
Germany
P: +49 8121 802-0
F: +49 8121 802-100
Machine design and used materials comply with:
- current GMP recommendations,
- OSHA regulations,
- CE requirements and
- 21 CFR part 11 whenever required,
- electrical standard EN 60204-1.
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
