Validation 101
Provides documented evidence that a system performs as expected
What is Validation?
The FDA regulation focused on electronic records and signatures
What is 21 CFR Part 11?
VRA
What is Validation Relevant Assessment?
Application used to manage and maintain compliance related training records
What is the Learning Management System (LMS)?
Typical business owners of applications that are used for Post-Market Surveillance Submissions data
Who is Marketing?
Document used to demonstrate testing of system functionality
What is a protocol?
The proposed FDA regulation focused on Tobacco Product Manufacturing Practices
What is 21 CFR Part 1120?
IQ
What is an Installation Qualification?
Application used to manage access to multiple validated computer systems
What is SNOW-AG?
Business function that typically provides technical support for validation relevant applications
Who is DBS?
Defines the scope and approach of validation for the companies.
What is the Validation Strategy?
Gives the FDA the power to regulate the Tobacco Industry
What is the Tobacco Control Act?
TM
What is Traceability Matrix?
Validated application utilized by laboratories to maintain inventory as well as instrument calibration records
What is Blue Mountain?
Function that provides guidance on validation procedures and strategy
Who is Legal?
Defines what an application or system is supposed to do and is used as the basis for a risk assessment
What are the Requirements?
The FDA Regulations focused on Tobacco Products
What are 21 CFR Parts 1100-1150?
ERES
What is Electronic Records, Electronic Signatures?
The application used to maintain validation documentation and allows us to perform electronic execution
What is Kneat?
Function that owns the Validation Relevant applications used to manufacture product, such as MES, Ignition, and EAP-OPS
Who is Operations?
Performed on a defined frequency to help ensure that an application or system remains in a validated state
What is a Periodic Review?
The FDA regulation focused on Enforcement Policies (i.e., Recall)
What is 21 CFR Part 7?
ALCOA
What is Attributable, Legible, Contemporaneous, Original, and Accurate?
The percentage of Validation Relevant requirements for MES1
What is 13?
Business function that uses data from Validated applications as part of FDA filings
Who are Submissions?