System documentation should include a system description, history, validation information, and references, according to Siegfried Schmitt, Vice President, Technical at Parexel. Q. Some 10 years ago, ...

Increasing adoption of CSV in regulated industries is a key factor propelling growth of the global computer system validation market. The use of computer systems can automate, accelerate and improve ...

VANCOUVER, British Columbia--(BUSINESS WIRE)--Elevated Signals, the manufacturing execution system (MES) for the cannabis industry, today announced it is GMP-ready, following third-party validation ...

Incorporating Q8, Q9, Q10 into good manufacturing practices (GMP), guidance on process validation, health based exposure limits covering cleaning validation and computerized system validation are the ...

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 ...

Title 21 CFR Part 58 provides guidance on Good Laboratory Practice (GLP) for executing non-clinical laboratory studies that support applications for research permits for Food and Drug Administration ...