Imagine for a moment that you are the CEO of a cutting-edge medical device manufacturing firm. You have just gotten your product to market after years of R&D, regulatory submissions, etc. Within ...

Entrepreneurs don’t generally like structure, and in your startup or small company, implementing formal written procedures may even seem counterintuitive to driving the creativity you want. Yet ...

The guidance is intended to assist institutional review boards and institutions in developing written procedures. Whether an IRB has written procedures on the topics identified in the guidance may ...

The US Food and Drug Administration (FDA) and Department of Health and Human Services’ (HHS) Office for Human Research Protections on Thursday finalized guidance on the written procedures ...

Often the people closest to the running of your company are your employees. Because your staff may perform the tasks and procedures regularly, they may even know more about these processes than you do ...

An overall SOP that covers all aspects of your business – from meeting and greeting to taking orders and processing payments – can be a means to satisfy customers on time, the same way, every time.

The US Food and Drug Administration (FDA) and the Department of Health and Human Services' (HHS) Office for Human Research Protections (OHRP) have released new draft guidance on the written procedures ...

In many facilities, repair is thought of as a one-off activity in which the technician pits his skill against a unique problem. That facility may have maintenance procedures, but because the details ...