Quality

Question 1

quality?

Answer 1

systematic continuous improvement process where management, resources, products and measurement systems are aligned to ensure continuous improvement and compliance

Question 2

QC?

Answer 2

tests products to ensure expected results

Question 3

QA?

Answer 3

tests processes to ensure they’re done correctly

Question 4

site/operational quality?

Answer 4

ALL quality activities at site level, including product testing and product release

Question 5

3rd party quality assurance

Answer 5

monitor outsourced manufacturing activities and monitor 3rd party activities

Question 6

R&D Quality?

Answer 6

partner w/ R%D to bring Q from start - in development, pre-clinical and clinical

Question 7

corporate quality?

Answer 7

support operational quality groups

Question 8

QMS?

Answer 8

in line with management, set company standards and create, implement and monitor QMS

Question 9

what do the quality unit have access to?

Answer 9

all relevant documentats about manufacturing, sampling, testing and results