As Thermo Fisher Scientific designs and produces Applied Biosystems, Invitrogen and Ion Torrent instruments, it understand the system better than anyone. Users can be certain that the instruments are ...

Global leader in laboratory services expands OneSource ® Laboratory Service offering to help pharma, biotech, and other regulated companies meet stringent regulatory requirements WALTHAM, ...

In the medical device world, laser welding encompasses a wide range of applications and part sizes. However, when laser-welding process cannot be fully verified, FDA requires that manufacturers ...

Metrohm’s response to Analytical Instrument Qualification is contained within the Metrohm Compliance Services document, while the most detailed level of documentation offered for AIQ is the IQ/OQ.

How has pharmaceutical manufacturing validation influenced analytical instrument qualification during the last 20 years and what are the emerging trends for the future? General guidelines regarding ...

Quality and reliability are essential in pharmaceutical manufacturing. To ensure compliance and high standards are consistently met, the Installation Qualification (IQ), Operational Qualification (OQ) ...

The author explores differences between two qualification documents, the draft guidance from FDA "Process Validation: General Principles and Practice" and the ASTM E2500-7 standard "Guide for ...

(click to enlarge)This is an example of a table that would be included in a qualification protocol in a prerequisites test section. An official copy of the protocol is printed and the tester fills in ...

SFJ Awards has launched a fire safety qualification with the aim to equip operational staff to deliver fire safety checks. Fire & Rescue Services attended more than 180,000 fires in the UK last year, ...

The OR Society has received official recognition from the Office of Qualifications and Examinations Regulation (Ofqual) to deliver the End Point Assessment (EPA) for the Level 7 Operational Research ...