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 ...

For laboratories that operate within quality management systems for compliance with global standards such as ISO 9001, ISO 13485, ISO 17025, ISO 15189, GxP, etc. and other country-specific regulations ...

A variety of modern innovative analytical instruments, ranging from a simple apparatus to complex computerized systems, are used in the pharmaceutical sector to get accurate data and to help ensure ...

With the AnaTox AIQ-Tool ® software all chromatographic systems that are approved according to USP/EP/JP can be easily and reliably qualified. The standardized procedure can be used for all systems of ...

Agilent Technologies Inc. has announced a major addition to its compliance services portfolio: Enterprise Edition, a lab-instrument qualification service for all major makes of liquid and gas ...

Computerized systems are those which comprise the components shown in Figure 1.1, namely, a computer system and a controlled function which is operating within its specified working environment. The ...

Course "Analytical Instrument Qualification and Validation: Understanding to Prepare for FDA Audits to become Part 11 Compliant" has been pre-approved by RAPS as eligible for up to 12 credits towards ...

Qualifying a UV spectrophotometer in the deep UV presents particular problems due to a lack of suitable reference materials and variation in the optical quality of spectrophotometer cells in this ...

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 ...