The loose pieces of paper that contain instrument printouts, customer communication records, or certificates and are attached to a laboratory notebook.
What are ADRs or Associated Data Records?
100
A term that means "atypical, abnormal, or unplanned incident or event".
What is a deviation?
100
On August 20, 1997, this regulation became effective to ensure electronic records are to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.
What is 21 CFR Part 11?
100
This material status is given to manufacturing materials when testing fail specification.
What is Non-conforming?
100
The term which means a single, specific underlying cause for a deviation.
What is a "Root Cause"?
200
This area of the notebook is where the "circle notes" are defined.
What are the "Notes and Comments"?
200
An activity performed by QC when a laboratory test result fails specifications or pre-defined criteria.
What is a laboratory investigation?
200
Under Part 11 rule, this type of records indicate the following: Printed name of signer, signature date and time, meaning of approval, review, authorship, etc.?
What are electronic records?
200
This form used to receive manufacturing materials by Materials Control (e.g. QC testing).
What is Laboratory Material Receipt form?
200
A tool used by pharma industry to help identify what, how, and why an event occurred so that steps can be taken to prevent future occurrences.
What is Root Cause Analysis (RCA)?
300
The name of the individual responsible for creating notebooks, reports, and archiving documents.
Who is Marcela/QA/CDU?
300
This type of activity is performed by QA after implementing a CAPA to determine its effectiveness.
What is an effectiveness check?
300
This government agency is responsible for regulating 21 CFR Part 11.
What is the Food Drug Administration or FDA?
300
These materials are required to be retained for the FDA.
What are APIs or Advantar manufactured products?
300
This type of Root Cause analysis systematically uses a series of question to drill down to a real root cause. It's the simplest of the two.
What is 5 Why's?
400
This process is performed at the completion of a project, equipment/computer qualification, after all notebooks and reports have been signed and approved for each stage of a protocol.
What is a "Closeout"?
400
An action to eliminate the cause of an existing discrepancy identified in a deviation or investigation.
What is a corrective action?
400
This type of activity assures that a computerized system does exactly what it is designed to do in a consistent and reproducible manner. Sometimes, this activity is required to be performed to meet part 11 compliance.
What is Computer System Validation or Validation?
400
The expiration date used for "in use" purified or analytical grade water
What is 1 month?
400
This type of Root Cause analysis identifies many possible causes to a problem by brainstorming and may be helpful when there are multiple root causes. This tool is also known as the "Cause and Effect" diagram.
What is Fishbone or Ishikawa Diagram?
500
This area is the only section/area of the notebook where raw data are allowed to be pasted.
What is a "Working Space"?
500
This type of deviation requires Customer approval and be closed out by QA prior to deviating from the procedure.
What is an External Planned Deviation?
500
The term used in 21 CFR Part 11 to define a system where access is controlled by persons who are responsible for the content of electronic records that are on the system (e.g. open or closed). Advantar systems are categorized as such.
What is a Closed system?
500
This type of laboratory material will require Certificate of analysis and an expiration date at receipt. Also, the labels placed on these materials and storage areas are orange in color.
What is a Reference standard?
500
This action can only be defined accurately if the true root cause of a problem is determined.
What is a CAPA or corrective and preventive action?