Change Request - CHVI-83602
What system is the preferred tool for managing GxP-relevant changes?
What does CRB stand for?
What are the three change categories?
TrackWise
Change Review Board.
Minor, Moderate, and Major.
What is a deviation?
Within how many business days should a deviation be initiated after detection?
What system allows closure of certain low-risk minor deviations without investigation?
Any unplanned and unexpected event resulting in non-compliance
One business day
Track & Trend
What is a Corrective Action?
What is a preventive action?
Who reviews and approves corrective/preventive actions?
An action to eliminate the cause of a detected nonconformity or other undesirable situation.
An action to eliminate the cause of a potential nonconformity or other undesirable potential situation.
QA.
What kind of tasks must be completed before implementing a change?
What kind of tasks are completed after implementation?
what helps to determine whether a change control is required according to change control SOP CHVI-83602
Pre-change tasks.
Post-change tasks.
Decision Tree as Attachment A in SOP CHVI-83602
What does SISQP stand for?
Who assigns the Quality Impact Rating and Risk Rating?
Who must be notified for Critical deviations during the DRB process?
Safety, Identity, Strength, Quality and Purity
Deviation Review Board
Responsible person (RP) / FvP (Fachtechnisch verantwortliche Person)
Before defining CAPA actions, what must be identified?
CAPAs may also be created without any deviation or regulatory finding for what ?
What assessment determines whether a CAPA prevented recurrence or occurrence of a defect?
Root cause.
Continuous improvement.
Effectiveness Check.
What must be evaluated for every change regardless of category?
Which assessment evaluates the impact on submissions and filings?
Which role verifies all pre-change tasks before implementation can proceed?
Need for an Effectiveness Check.
Regulatory Impact Assessment.
QA.
How is a Minor QIR defined?
How is a Major QIR defined?
How is a Critical QIR defined?
What example would typically result in a Major QIR?
No impact on product quality or patient safety
Potential or unclear impact on product quality
Confirmed impact on product quality or patient safety
Breach of a Critical Process Parameter (CPP)
Which CAPA category is considered weakest?
What does SMART stand for CAPA ?
What is the strongest CAPA category?
Retraining/Awareness.
Specific Measurable Accountable Reasonable Timely.
Elimination.
What is a Concept Change?
Which four assessment areas contribute to the risk assessment score?
Under what condition may QA close a CR that requires an Effectiveness Check?
A record used to manage broad or complex changes containing multiple Change Requests.
Regulatory, Product SISQP, Validation/Qualification, and EHS.
The EC must be properly populated and in the correct state, or there must be documented justification for not requiring one.
What must be defined before starting an investigation?
What RCA method is commonly used for simple deviations?
What is another name for the Ishikawa Diagram?
A problem statement
The 5 Whys
Fishbone Diagram
What is the target timeline for defining a CAPA Action Plan?
What status must an EC have before CAPA closure?
What is the typical EC assessment period?
5 business days.
Work in Progress.
6 months
Who is responsible for ensuring all affected documents are identified and documented in the CR?
If a temporary change reaches its expiry date, what must occur?
Which role decides whether customer approval is required?
The Change Manager.
The system/process must be returned to its original controlled state.
QA, with support from RA when needed.
Within how many business days must the DRB occur after deviation initiation?
How many extension requests are normally permitted?
What is the only acceptable reason for cancelling a deviation?
How is a recurrent deviation defined?
Two business days
Only one extension
A duplicate deviation
The same known root cause occurred again despite previous CAPA
How many extensions are normally permitted?
In which states may CAPAs be cancelled?
Give one valid reason for CAPA cancellation.
One.
Opened or Response.
Duplicate CAPA, opened in error, premature child CAPA, or discontinued project.