Used to document steps completed during manufacturing.
Department that tests samples to confirm product meets specifications
Our first responsibility is to the doctors, nurses, and ______...
Electronic system that tracks batches through the manufacturing process.
General name of medical device components manufactured in Janssen, Athens.
Launched in October 2017, it is the electronic system used to document quality issues.
Any modification to a validated process must be approved using this risk assessment record.
Data must be easy to read.
_______ is responsible for delivering high quality.
Data reflects what actually happened without edits or changes.
Proof that an instrument or device produces "correct" results.
J&J Regulatory Compliance team that periodically audits our site.
A chronological list of actions completed in an electronic system, which is reviewed as part of Data Integrity.
Down
Theme of Quality Month 2017: Drive ______ quality, enable growth.
Good Manufacturing Practice
Data must be clearly linked to who did it.
Documented evidence that a specific
process, operated within established
parameters, will consistently and effectively
produce a product meeting its
predetermined specifications and quality
attributes..
Refers to the completeness, consistency, and accuracy of data.
Everything we do must be of high _______.
Data must be the first, true copy.
The values that guide our decision-making are spelled out in this document.
Who is responsible for quality?
Document sent with product shipments; lists test results and conformity to specifications.
Acronym that defines the elements of Data Integrity.
Active Pharmaceutical Ingredient
Janssen is approved to manufacture API's by this US Agency.
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It prints on two pages.
Big puzzles won’t always print on one page — the clues and grid are the smallest we could make them while keeping them readable for everyone.
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