QMS

GxP What-is-GxP-acronym-definition

What is GxP compliance?

Industry support of overdose prevention
This is blog 8 of 10 Blogs in the overdose awareness and overdose prevention series.

What is GxP compliance? And how does GMP/GxP compliance help with overdose prevention efforts?

GMP and GxP are pharmaceutical-industry quality standards and …

Form-Use

Form Use – the right way to fill in a form

Following on from the previous blog Form Design – it’s all about the white space, comes the exciting part deux: Form Use – the right way to fill in a form.
There is a general misconception that data integrity failures …

form-design

Form Design – It’s all about the white space

Tax.
Return.
Form.

That sent a shiver down your spine, didn’t it?

Because it’s longwinded, boring, complicated, sometimes unintelligible, and usually frustrating. Plus, there’s that added frisson from the fear of imprisonment due to unintentional tax fraud.

Form design might seem like a banal …

GMP-documentation

GMP Documentation – Top Tips for Writing User-friendly GMP Documents

Good documentation (and well-written procedures) is key to achieving compliance with GMP requirements. GMP documentation should include enough ‘instructional detail’ to ensure that processes are well understood and user friendly, and should be ‘…designed, prepared, reviewed, and distributed with …

Pharmaceutical-Quality-Systems-pqs

Pharmaceutical Quality Systems (PQS) 101

Well-written documentation and a comprehensive and well-designed Pharmaceutical Quality System (PQS) can be a manager’s best friend.

Pharmaceutical Quality System (PQS) documents:

provide guidance and instructions for employees to complete the day-to-day activities
are the ‘go-to’ during an audit or …

vial-inspection

5 Things to Know About MDSAP in 2020

What is the Medical Device Single Audit Program (MDSAP)?
The Medical Device Single Audit Program (MDSAP) was launched by the International Medical Device Regulators Forum (IMDRF) in 2014 as a pilot program, satisfying the requirements of the pilot program in …