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If you hold a GMP licence, make ensure you validate your IT system!
Have you been told, often by your finance department that you must prepare for a new computer system? If so please ensure you raise a change control form and carry out a robust risk assessment . All too often the implementation does not run to plan and the results can...
What does a WDA holder have to qualify & validate?
What does a WDA holder have to qualify & validate ? Their processes, procedures, equipment, packaging, transport, service providers etc. They have to calibrate equipment and temperature data loggers , balances etc. Validation, qualification and...
What should you look for in an outsourcing partner ?
Outsourcing should be considered in small and large organisation where where an expert third party is more effective and economical. The alternative is to employ and train in-house experts or retrain existing team members. Quality Expertise can be sought in diverse...