Cardinal Health Products
This type of tubing is used to remove fluids from the surgical field and maintain visibility during procedures.
What is suction tubing?
Entries must be made at the time work is performed.
What is contemporaneous documentation?
GMP ensures products are produced according to these.
What are quality standards?
Internal audits help identify these early.
What are nonconformances?
This foundational quality principle ensures that every step of a process can be traced back to its origin, including materials, decisions, and documentation.
What is traceability?
Devices that help manage medication dispensing and reduce errors.
What are automated dispensing systems?
Corrections must never obscure the original entry.
What is a single‑line strike‑through?
Training required for all personnel performing GMP activities before documenting a quality record.
What is GDP training?
FDA document listing inspection observations.
What is a Form 483?
QA ensures products meet these before release.
What are specifications?
These sterile barriers are placed over the patient or equipment to maintain a clean surgical field.
what are surgical drapes
All entries must reflect the truth.
What is accuracy?
Facilities must maintain this to prevent contamination.
What is cleanliness or controlled environment?
Sampling method auditors often use.
What is risk‑based sampling?
CAPA stands for Corrective and this type of action.
What is Preventive?
This essential protective product is worn on the hands to prevent contamination and protect both clinicians and patients.
What are medical exam gloves?
Acronym for attributable, legible, contemporaneous, original, accurate.
What is ALCOA?
Equipment must undergo this to ensure it performs as intended.
What is validation?
A serious regulatory finding posing patient safety risk.
What is a critical observation?
Document defining how a process must be performed.
What is a standard operating procedure (SOP)?
These solutions and devices support hydration, nutrition, and fluid balance for patients who cannot take food orally.
What is nutritional and fluid management delivery?
Acceptable only when Part 11 compliant.
What is an electronic signature?
Ensures raw materials meet specifications before use.
What is incoming quality control?
During an audit, this type of evidence is preferred because it can be independently verified and does not rely on personal statements.
What is objective evidence?
ISO 13485 is a QMS standard for this industry.
What is the medical device industry?