In my experience, I believe that staying informed about the industry is one of the most important aspects. The first and biggest reason is knowing you...

In my experience, the leadership and their motivation have been the biggest hurdle for the innovation and research for the company I work for. My comp...

Efficient and proper validation is key for proper functionality. The validation I have seen that very key in certain institutions are testing of every...

I agree with your justification but to take a step further, I believe the reevaluation should be done as often as possible. Granted a full reevaluatio...

I very much agree with your statement. Internal audits are essential for keeping an up to date quality system. Implementing CAPA as a result of intern...

I agree with hm243 that a reevaluation has more benefits than pitfalls when observing the various location of equipment use. However when multiple loc...

I believe is always beneficial to be proactive rather than reactive. In a reactive system you solve matters as they arise, this can lead to possible b...

I agree that technical writing is an essential skill that all engineers should have. Mandating classes that help students practice this skill will be ...

I may be misunderstanding your question, but revised documents should always be updated. If any other document references the changed document, then t...

The FDA provides guidelines on validation processes with the purpose to ensure varied inputs lead to consistent and high-quality results. The process ...

The point of a QMS helps coordinate and give instruction to an organization’s activities to meet customer and regulatory requirements and improve its ...

A particular change order that occurred was that my companies supplier for a certain plastic was changed. The difference was very slight but however, ...

When writing SOPs, detail is very important. Your manager is correct, a random person should be able to complete the procedure. However, the in-depth ...

SOPs contain the regularly recurring work processes that are to be conducted within an organization. It states the activities that are to be performed...

I agree with your method of using a regression test to save resources. But this might not always identify the issue. By using a less involved method f...