The author discusses the collection and evaluation of data part of FDA’s definition of process validation. Process validation is more than just running three consecutive batches under manufacturing ...

When pharmaceutical companies develop a novel drug for the market, several steps are required to assess and regulate its safety, effectiveness, manufacturability, and reliability. These processes, and ...

Designing an efficient platform is crucial for any industrial process. This design process is known as process development, and it has become increasingly important in the pharmaceutical industry at ...

Audit. Compliance. Team training. Process re-engineering. Every one of these activities requires that your team have accurate business process documentation in-hand to maximize success. Is it optional ...

Unlock the full InfoQ experience by logging in! Stay updated with your favorite authors and topics, engage with content, and download exclusive resources. Vivek Yadav, an engineering manager from ...

Adi Klevit, an Entrepreneurs’ Organization (EO) member in Portland, Oregon, is the co-founder of Business Success Consulting Group, which helps leaders create and document custom processes and ...