Professional Documents
Culture Documents
Auditing
The Biomedical Auditor works with medical devices, including in vitro
diagnostics and biologics that are regulated as medical devices. The
biomedical auditor's principal function is to accurately and objectively report
to management on the effectiveness of business processes to achieve
business objectives, including compliance with regulatory requirements.
As an auditor in an industry
regulated by FDA, you have a
very important responsibility
for the overall quality of the
goods your company produces!
*Define the scope of the audit …… What exactly will you be looking at?
*Inform the auditee of the impending audit as well as the areas that you will be
covering and items you will need to see.
*Identify and review all applicable regulations, ISO, QSR, AAMI, etc., Internal
Standard Operating Procedures, and any other documents used in the operation.
*Conduct an opening meeting with individuals responsible for the area , and
anyone else you feel could be affected by this audit.
You need to reference which standards and internal
documents apply to the audit………
Regulations and Standards
*21 CFR Part 11 Electronic Records/ Signatures
*21 CFR Part 50 Protection of Human Subjects
*21 CFR Part 54 Financial Disclosure by Clinical Investigators
*21 CFR Part 56 Institutional Review Boards
*21 CFR Part 58 Good Laboratory Practice for Non Clinical Studies (See appendix A)
*21 CFR Part 812 Investigational Device Exemptions
*21 CFR Part 820- Quality System Regulation
*ISO 14971 Medical Devices, Risk Management System
*ISO 13485:2003 Medical Devices - Quality Management Systems
*ISO 14155-1:2003 Clinical Investigation of medical devices for human subjects General Requirements
*ISO 14155-2:2003 Clinical Investigation of medical devices for human subjects Clinical Investigation Plans
*Guideline for Good Clinical Practice – ICH
*Declaration of Helsinki
*HIPAA
Internal Documents
7000-XXX Rev 00 QUALITY SYSTEM MANUAL
7000-XXX Rev 00 REQUIREMENTS FOR XXXXXXX SPONSORED CLINICAL TRIALS
7000-XXX Rev 00 MEDICAL SERVICES DEPARTMENT
7000-XXX Rev 00 SITE INITIATION VISITS
7000-XXX Rev 00 STUDY SITE CLOSE-OUT VISITS
7000-XXX Rev 00 FINANCIAL DISCLOSURES
7000-XXX Rev 00 SPONSOR STUDY FILES CONTENTS
7000-XXX Rev 00 DEVICE ACCOUNTABILITY
7000-XXX Rev 00 PATIENT INFORMED CONSENT FORMS
7000-XXX Rev 00 STUDY SITE MONITORING VISIT
7000-XXX Rev 00 QUALIFICATIONS OF INVESTIGATORS AND SITES TO CONDUCT RESEARCH
7000-XXX Rev 00 SAS SOFTWARE USE, MAINTENANCE, AND VALIDATION
Put your list of questions together….
ISO 14155-1:2003 (5.3), (6.7.3f) /21 CFR Part (50.25) / ICH (4.8.10) / 7000-XXXX
1.How do you ensure patients are duly informed of risks, benefits, etc. of trial
participation?
ISO 14155-1:2003(6.1) (8.2) (10.2)/ 21 CFR (812.43(a) ,(820.50(a) / SOP 7000-XXXX/ SOP D00XXX
3.How do you ensure investigators, research personnel, and sites have the
necessary qualifications to conduct research?
Etc….Etc…..
*In addition to using your checklist, take DETAILED notes! There WILL be things
that you won’t remember as vividly as you think!
*Let the auditee know that note taking helps you do your job and doesn’t automatically
mean there is a problem. Explain that the audit is a way to help them work out any issues
or problems in their area.
* Notified bodies (FDA ,TUV,etc.) are not allowed to review the results of internal audits,
only proof that audits are being conducted.
*Ask for several examples of relevant documents…..verify and make copies if possible!
Never take anyone's “word for it”………..You must collect OBJECTIVE EVIDENCE!
*Use your checklist as a guide , and be sure to follow audit trails when needed.
Creating the Audit Report:
*Remember : Auditors are looking for both compliant and non compliant
activities!
Observation: An issue that does not rise to the level of a major or minor finding as
described above. Usually observations are made for issues that are not clearly GMP
deviations, to recommend a better way to accomplish a task, or simply a statement of
findings.
Conduct the Closing Meeting……
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