OOS Investigations
The data generated by your company or a contract laboratory is an important part of your overall quality program. We understand the impact of data that does not meet acceptance criteria or established limits, and the concern that may cause you, our clients. MicroGuard consulting has many years of experience in dealing with out-of-specification and other aberrant microbiology data and can assist you in understanding the data and its implications, as well as the proper means to investigate the data.
MicroGuard Consulting can review OOS Investigations prepared by the client or your contract lab, or participate in OOS Investigations to ensure an in-depth investigation aimed at determining root cause. We can also recommend appropriate corrective and preventative actions and assess suitability of those actions. Our services include investigation of:
- Environmental Monitoring excursions
- Production water above limits
- Sterility test positive findings
- Microbial Examination OOS Investigation (Microbial Enumeration and Test for Specified Organisms)
- Antimicrobial Effectiveness Test failures
- Endotoxins OOS
- Biological Indicator failures
- Antibiotic Bioassays OOS
- Sterilization Validation protocol failures
- Gowning monitoring above limits
- Other related microbiology data excursions
