Quality Assurance Files

NAICC 2013

Quality Assurance Files

• Master Schedule

• QA Study Specific Files

• Facility Audits

• Other

• NAICC 2013 Page 2

Quality Assurance Files

160.35 Quality Assurance

• ‘…The quality assurance unit shall conduct

inspections and maintain records appropriate to

the study.’

NAICC 2013 Page 3

Quality Assurance Files

Test Facility Master Schedule

• Maintain a copy of the Master Schedule*

• Indexed by test substance &

• Containing:

• Test system

• Nature of study

• Study initiation date

• Current study status

• Sponsor

• Study director

• NAICC 2013 Page 4

Quality Assurance Files

• QA study files…

• Copy of the protocol*

• Audit of the protocol (when applicable)

• NAICC 2013 Page 5

Quality Assurance Files

• QA study files…

• Study inspection/audit reports* • Signed

• Date of inspection

• Study inspected

• Phase or segment of study inspected

• Auditor’s name

• Findings

• Action recommended & taken to resolve problem(s)

• Any scheduled reinspection date

• NAICC 2013 Page 6

Quality Assurance Files

• QA study files…

• Final Report or PFI Report & data review

audit*

• Checklist

• Audit findings

• Text and/or table examples

• NAICC 2013 Page 7

Quality Assurance Files

• QA study files…

• Other items in these files

• QA Statement (copy)

• Notes

• Audit schedule or notification

• Emails

• NAICC 2013 Page 8

Quality Assurance Files

• Other Types of Files…

• Facility Inspections of your test site

• Process Inspections – site records reviews

• Periodic Status Reports

• NAICC 2013 Page 9

Quality Assurance Files

• Other Types of Files…

• CRO or PFI Facility Inspections

• Agency Notice of Inspection letters/emails,

Inspection Reports & Audit Closing Letters

• NAICC 2013 Page 10

Quality Assurance Files

• Retain the QA Files

• Recommend archiving

• Index of QA Records

• NAICC 2013 Page 11

Quality Assurance Files

• Other Types of Files…

• QA CV & Training Records

• QA SOPs

• NAICC 2013 Page 12

Thank You!

• NAICC 2013 Page 13