The webinar highlights opportunities in enhancing system validation, utilizing agile and waterfall methodologies, and leveraging COTS, SaaS, IaaS, PaaS, and cloud solutions to meet FDA requirements ...
Market opportunities lie in modernizing software development and validation approaches, emphasizing agility and continuous validation to meet changing needs, while ensuring compliance with FDA ...
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 ...
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 ...
Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex ...
The Board of the Eurasian Economic Commission has adopted Guidelines on Ensuring Data Integrity and Validation of Computerized Systems. The manual contains recommendations for pharmaceutical ...
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 ...
Although the pharmaceutical industry works to the same regulations there are wide differences in company interpretations. Often the interpretation for CSV can be inflexible, onerous, slow and a ...
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