Audit and Assessment of
existing studies, documentation, practices, policies, procedures, evidence,
Triage observations in terms of practical compliance approaches.
We audit for Validation
using a Risk-based Approach. Failure to comply
with the Quality System Regulation can cause serious
consequences for pharmaceutical and medical device
manufacturers, including 483s, warning letters, consent
decrees and more. We ensure you will comply with cGMPs
and ensure processes are validated and completed to
ensure product safety. It is essential to audit to
the quality system environment.
We focus on the FDA’s emphasis on a risk-based approach.
We use audit tools that can be used to verify
effectiveness of such systems, and develop effective
internal auditing techniques.
Audits can be conducted before or after a regulatory
inspection, however we would encourage the use of our audits to assist you in
readiness and personnel development, project tracking and implementation of your
overall Improvement Programs. The types of audits we specialize in are:
- General Quality System audits.
- Process validation audits.
- Complaint Handling
- Medical Device Reports
- Design History Files
- Device Master Records
- Device History Files
- Comparison of report text to the study protocol, procedures,
compendia, and analysis plan
- Central Files Auditing
- Data Systems Auditing
- Statistical Systems Auditing