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Cenduit Quality Manual Crossword Puzzle

Horizontales
Data recorded in the IRT systems is ____ by the sponsor
Any corrections shall not ____ the original data
Cenduit's position on a subject relation to regulatory compliance or business practice
Procedures are developed to assess relevant ____ systems for compliance with 21 CFR PART 11
The Quality Manual and related Quality System applies to Cenduit ____
This team works alongside those responsible for moving studies into the live production environment
These procedures address the unique needs of a client
This establishes a documented hierarchy for the quality framework within which the entire company operates
This team advises on items that present significant risk and to authorize certain items as defined within the Quality System
Cenduit is not responsible for the validation of this instrument
The QA staff supports ____ offices
A listing of computerized systems supporting clinical trials, their validated state, and their relevance to 21 CFR Part 11 is ____
Any misconduct or fraud on the part of Cenduit or study personnel must be ____ as soon as possible
Cenduit procedures that govern the entire organization
The QA staff is ____
Verticales
Records shall be maintained for a minimum of ____ years following study close-out
This recovery minimizes the downtime associated with disastrous event
Step-by-step ____ instructions
Quality Function is divided into how many supporting elements?
An electronic signature is legally ____
Client Oriented Resources & Engagement
Documents organized within a specific hierarchy
Electronic source files will be finalized in this format
QA gives ____ to Cenduit regarding compliance
The Quality Assurance (QA) group is ____
Management Review contents are ____
Recovering and restoring operational capability after COVID falls under ____ continuity
The protection of the confidentiality of trial subjects is regulated according to ____
Any issues that present a significant and immediate risk to patient safety, study integrity, data integrity, and/or drug accountability will be escalated and documented within the ____ system
Used to gather information using a prescribed format