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, ...
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 ...
OSAKA, Japan, Dec. 4, 2025 /PRNewswire/ -- HiroPharmaConsulting (R) Co., Ltd. announced that it has received a patent for an innovative Good Pharmacovigilance Practice (GVP) Computerized System ...
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 ...
Dublin, May 14, 2025 (GLOBE NEWSWIRE) -- The "Risk-based Computer System Validation; Reduce Costs and Avoid 483s (ONLINE EVENT: August 6-7, 2025)" has been added to ResearchAndMarkets.com's offering.
Dublin, Aug. 25, 2025 (GLOBE NEWSWIRE) -- The "Digital Validation Demystified - GAMP? 5 2.0 and CSA Integration" training has been added to ResearchAndMarkets.com's offering. This course equips you ...