Showing posts tagged with: quality management system
Cup of Joe 44# - Whose monitoring responsibility is when you have outsourced production?
When someone owns a medical device company, but not having a space or supplies for producing equipment, then they hire a contractor, outsourced manufacturer.
So, he is providing all the services regarding life-cycle products. If you think you've taken a heavy load off your back, you are wrong.
Please, read the regulations and standards again.
Let us remind...
Cup of Joe 38# - There is such a thing like painless audit?
An audit is verification of activities – process or quality system in order to ensure compliance to some requirements. As such audits always generate tension and anxiety – because you know that some stranger is coming to check your work and could give you a failing grade!
Painless = prepared, the more prepared, the more painless.
Standard...
Cup of Joe 35# - Signing your electronic documents
One of the main criteria for an eQMS is to have implemented an electronic signature.
Many eQMS software have found many ways to handle this issue, but they all have to satisfy 21 CFR part 11. This part clearly paraphrases the fundamental rules of electronic signature implementation and control for compliance needs.
When we are talking about...
