Quality Systems
The Quality System element that manages issuance, version-control, and archival of GxP documents and records.
What is Document Control?
We have 30 days from the day a Field Action is initiated to accomplish this task
What is submit a FSCA (Field Safety Corrective Action)?
PIA stands for
What is Product Issue Assessment?
A record that contains results, information, or provides objective evidence of the fulfillment of the quality requirements as defined by the quality system.
What is a Quality Record?
DePuy's first name
What is Revra?
The Quality System element that manages implementation of modifications to product processes, equipment, and utilities.
What is Change Control?
Timeframe to submit a complaint
What is 1 business day/3 calendar days in case of public holiday?
This is the Product Esclation SOP #
What is PR551-002?
Identification, traceability, signatures, and context are all key aspects of this ALCOA principle.
What is attributable?
A large, fish-eating bird of prey found near water all over the world
What is an Osprey?
The Quality System element that manages the implementation of corrective and preventative actions.
What is CAPA Management?
The minimum training period for trainable documents for DePuy & Synthes
What is 14 days?
This is the Field Action SOP #
What is PR-0000109?
In good documentation practices, the process of changing an original annotation due to an entry error or update in a document.
What is a correction?
City and state of the first DePuy site
What is Warsaw, Indiana?
The Quality System element that manages implementation of modifications to product processes, equipment, and utilities.
What is Change Control?
These 3 have a 45 day timeliness target
What is NC & CAPA investigation and PIA decision?
This is where CR approval requirements are found for DePuy.
What is SEP-080?
Creating, altering, recording, manipulating, or deliberately omitting data in a way that data does not represent what occurred.
What is falsification?
Location of first Synthes site
What is Oberdorf/Waldenburg?
This Quality System element is the formal, documented decision-making process by a Quality Unit to determine the final status of products—released or rejected —based on compliance with specifications, test results, and manufacturing records.
What is Batch Disposition?
We have 10 days from time of field action initiation to submit this to the local district FDA office
What is a FDA 806 report?
The Synthes step-by-step instructions for Windchill change process for Change Owners
What is the Job Breakdown Sheet of 103459987?
ALCOA stands for
What is attributable, legible, contemporaneous, original and accurate?
The year DePuy and Synthes were married
What is 2012?