Quality Manual
: Documents tracking actions taken to eliminate the root cause of an existing non-conformity or prevent its recurrence.
Specifications and Analytical Methods
While QC performs the testing, QA reviews and manages the documentation generated by laboratory activities.
: Documented findings from physical or desktop audits of a supplier’s manufacturing facilities and quality systems. list of qa documents in pharmaceutical industry
Documented verification that the equipment or systems perform as intended throughout their anticipated operating ranges.
: Formal documentation of any unplanned departure from an approved SOP, manufacturing instruction, or specification. Quality Manual : Documents tracking actions taken to
"Precisely," Marcus smiled. "The document is the proof of the process."
Product Complaint and Adverse Event Reports or specification. "Precisely
: Documentation verifying that personnel are properly educated, trained, and qualified to perform their assigned job functions.