ISO 17025 method validation software
We develop and supply a complete, simple-to-use, competitively-priced, method validation software for ISO/IEC 17025 testing laboratories and for the healthcare-life sciences, EffiValidation 3.0.
The software brings both laboratory and business advantages such as:
- Standardizing and centralizing quality with coherence and regulatory-compliance.
- Reducing management complexities, shortening execution timelines and cutting operational costs.
- Ensuring data security and traceability.
Our software can be used for a variety of purposes including water quality, food safety, healthcare delivery or environmental management, regardless if the test methods are chromatographic (HPLC, GC or TLC), spectroscopic (UV/VIS, AAS, ICP, MS, ..), classical (titration, gravimetric), or other.
In addition, we offer a full range of support services such as user and administration training, on-site validation, document development, risk assessment and auditing.
Please select one of our solutions, go to the DEMO version section, or open EffiChem leaflet – basic company presentation.
News
August 18, 2011
A comprehensive list of guidance documents by FDA / CDER (PDF – 559KB)5,
(updated 9/6/2011) was made available.
See full document HERE.
May 17, 2011
Week 19, training was held for our top client, Micron Italy. Both the
theoretical and practical examples were included.
We have learned that further development of validation protocols for use in
specific application areas such as semiconductor industry would be very helpful
for our customers. We will work on this for the future.
April 10, 2011
EU GMP Annex 11. COMPUTERIZED SYSTEMS, revision 1, coming into operation on
30 June 2011.
See full document HERE
Reasons for changes: the Annex has been revised in response to the increased use
of
computerized systems and the increased complexity of these systems.
