Sympatec's Quality Management System (QM system) is primarily designed to get the optimum performance and best system-to-system reproducibility of all our particles sizing instruments under real conditions.
It is completely adapted to the requirements of the Pharmaceutical Industry which are in general higher than those known from the widely used ISO 9000 and subsequent standards. This QM system covers the development, the production, the service and the connecting work flows.
Since its introduction in 1984 Sympatec's QM system has been hardened and successfully audited by many renowned Pharmaceutical Companies. As these companies also check our QM system against their internal company standards, Sympatec's QM system has become a super-set of all relevant requests, resulting in audits with no or little findings and full compliance with the FDA requirements.
|1.||A comprehensive set of Standard Operation Procedures (SOP's)||Describing all procedures of the development, manufacturing, service and work-flows|
|2.||Life Cycle Model||All developments are based on a life cycle model, the V-model.|
|3.||Reference Materials||The final test of the production is the Performance Qualification. All our instruments are tested with real particles in a realistic application, i.e. by measuring the particle size of reference materials|
|4.||Internal and External Audits||Audits are used to continuously revise, improve and check the proper function of the QM system|
|1.||Independency||The quality manager directly reports to the technical director and works independently of production, development , service, and staff|
|2.||Identical standards||The tests are not depending on the instrument type or the final application, all instruments are tested for the potential use in the pharmaceutical industry.
In-line instruments are tested with the corresponding procedures of the corresponding off-line instruments allowing for maximum system-to-system reproducibility.
|3.||Narrow quality limits||Sympatec is using quality limits which are in general narrower as requested by the corresponding ISO standards in order to obtain the best possible system-to-system reproducibility|
|4.||Quality first||No system will be shipped unless it has passed all test successfully|
|5.||Traceability||All steps of development and production are documented in written, so a copy of the production documents can be used for subsequent re-certification or validation of the instruments.|
|1.||Compliant with ISO standards||All our instruments are designed to fulfil or to exceed the requirements of the corresponding ISO standards, such as ISO 13321-1 for Laser Diffraction, ISO 13321:1996 for PCS, ISO 13322-1 for Image Analysis etc.|
|2.||21 CFR Rule 11 Compliance||
The operating software, WINDOX, for all Sympatec instruments has been designed to provide all technological controls required to achieve compliance with 21 CFR part 11, including both, electronic records and electronic signatures
|3.||Validation & Re-certification Support||Sophisticated procedures are available from Sympatec together with the necessary paperwork, the test sheets, the validation documents and the reference materials in order to perform re-certifications or qualifications for instruments used or located in validated processes.|