Data Integrity
This principle means the data is clear and can be easily read and understood.
Legible
Who said "Quality means doing it right when no one is looking"?
Henry Ford
GMP
Good Manufacturing Practices
These are the two acceptable colors of ink to be used on documentation.
Blue or black
Who is responsible for ensuring quality?
EVERYONE!!
Ensuring that data is recorded on a certified true copy maintains this principle.
Original
Who is known as the father of Quality?
Edward Deming
QMS
Quality Management System
What's the proper date format?
DD-MMM-YYYY
In how many days are you expected to complete an IDBS experiment?
70 days
What's the definition of contemporaneous?
The principle that emphasizes data should be recorded at the time it is performed, not backdated or predated?
Who developed a trilogy consisting of QC, Quality Planning, and Quality Improvement?
Joseph Juran
CAPA
Corrective Action Preventative Action
What's the proper way to correct a documentation error?
Cross a single line through the error, initial, and date.
What record is reviewed to ensure the data is attributable?
Audit trails
This regulation outlines the requirements for electronic records and electronic signatures.
21 CFR Part 11
This is an approach to quality improvement that emerged in the late 1990s. It is a customer focused, result oriented approach to business improvement.
Lean Six Sigma
ALCOA+
Attributable Legible Contemporaneous Original Accurate Complete Consistent Enduring Available
What are the minimum labeling requirements for non-GMP purchased materials?
non-GMP status, received date, analyst initials
What are the on-time completion targets for Quality metrics?
100% for CAPAs, ECs, deviations, risks, change controls. 95% for controlled documents. 98% for training.
The entire file path for location of raw data is recorded. Data backed up to a common server.
Who is credited with developing the term Gemba?
Taiichi Ohno
DMAIC
Define Measure Analyze Improve Control
What are the labeling requirements for analytical samples?
Identity, Batch reference or other unique identifier, LIMS reference, Storage conditions, Scientist identity
What are the two main criteria used to evaluate overall risk?
Severity and occurrence