Monetary benefits will outweigh the hassle of batch record harmonization, says Siegfried Schmitt, principal consultant at PAREXEL. Q: Our company recently acquired several new production sites in ...

As a part of international regulatory standards of GMP, pharmaceutical industries are required to maintain documentation of the entire manufacturing process and batch execution process. ? Laborious ...

Implementing electronic batch records can offer a means of compliance, reduction in errors, streamlined ability to trace actions, and simultaneous generation of documentation. An electronic batch ...

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