Unstructured data present both a compliance risk and a missed opportunity for growing organisational knowledge...
Unstructured data present both a compliance risk and a missed opportunity for growing organisational knowledge...
For pharmaceutical and other life science disciplines, the ‘5Ps of GMP’ are a useful way of thinking about the...
The FDA’s Quality System Regulation (QSR) for medical device manufacturers is commonly known as FDA 21 CFR Par...
Inadequate document review is often to blame for failure in new product development and manufacturing processe...
GMP is part of the best practice guidelines (GxP) which the FDA and other official bodies refer to in their re...
Medical device audits can be a source of stress for developers and manufacturers. But what exactly are the aud...
In a Lean approach to product development, customer value is defined as ‘everything the customer is prepared t...
There are many reasons why an organisation might need to document their SOPs. From training staff and identify...
It’s much easier to screw up a new product development process than mastermind a successful one. Here’s how.
