At Labshire, we serve as your compliance partner so you can focus on your core activities.
We bring a wealth of knowledge, experience, and judgement which, exercised through our unique approach to laboratory management, provide you with workable solutions tailored to your unique situation. This includes conducting gap analyses and leading your laboratory to inspection readiness.
If each time you face an inspection, you find yourself rushing to get ready and feel like you are on the edge of a cliff where a fall into non-compliance seems imminent, then you need us. Why?
Because navigating the intricate landscape of global regulatory bodies and their requirements can prove to be a challenging endeavor even when you try to keep up on a routine basis. The consequences of noncompliance range from wasted time, money, and personnel resources to sanctions, fines, recalls, customer dissatisfaction, and more. The cycle of unpreparedness can lead to cramming years of compliance readiness into a few months or even weeks each time an inspection approaches followed by a rush to correct the findings. The result? Increased risk for losses due to regulatory and liability problems; potential loss of confidence by corporate managers and potential investors; as well as misallocation of limited resources away from the primary mission of the laboratory
Our compliance services can provide you with:
- A team of expert consultants in regulatory inspections, risk management, and remediation
- A comprehensive training program that can be personalized to your laboratory’s situation
- A library of qualification documents and methods that will be customized for your processes.
- A path to successful document and knowledge management to support your operations
- Expertise in regulatory and compliance that includes:
- Title 42 CFR Part 493: US Code of Federal Regulations Laboratory Requirements Clinical Laboratory Improvement Amendment (CLIA)
- Title 21 CFR Part 58: US Code of Federal Regulations, Good Laboratory Practice for Non-Clinical Laboratory Studies
- Title 21 CFR Part 11: US Code of Federal Regulations Electronic Records; Electronic Signatures
- ISO15189: Medical laboratories – Requirements for quality and competence
- HIPPA: Health Insurance Portability and Accountability Act
