Validating software

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The software’s intended use must be implemented, and personnel training in everyday operations must be conducted.The company must ensure that user requirements, specifications, and instructions match the intended use.Computer systems must comply with c GMP requirements, when used in these regulated environments.As continuous technology advancements, cloud computing, virtualized process control systems and manufacturing networks, including security, converge into a technology-driven, ever-adapting industry, so does the potential risk of non-compliance with both internal instructions as well as regulatory governance.

Download the Minitab 18 Software Validation Kit For clarifying examples regarding software validation, visit the Minitab blog.The kit includes information about our software testing procedures and an automated script of representative analyses with instructions for use.The output you generate from the script can be compared to an output file we have validated internally.Users responsible for computer systems in pharmaceutical environments have raised legitimate questions con-cerning perspectives, validation strategy, scope, and methods when validating these systems.

Validation of computer systems is a task often regarded as abstract and rather complex.In contrast, several risk-averse pharmaceutical companies choose to validate, in-depth, vendor-supplied pre-validated “standard” software.

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