The audit / inspection season is in full swing. SBME has been in two inspections in the last 30 days and there is some low hanging fruit that may help you prepare for your own upcoming audits. 1. CAPAs – Make sure your team is trained on the proper definitions of corrections, corrective actions and preventive actions. These definitions are a direct quote from an inspector during a recent audit: A “correction” fixes the immediate problem. A “corrective action” stops the same problem from happening in the future. A “preventive action” stops a problem that has not occurred 2. External Standards – A company should have applicable standards available for staff to refer to. If a standard changes, a gap assessment of the change needs to be performed and a decision should be made as to whether a standard needs to be obsoleted (not available to staff). 3. Risk Management – Obviously the risk management process should be compliant with ISO 14971 but also be sure to have a conclusion statement in the risk management report that residual risks are acceptable with an adequate justification. 4. Independent Reviewer for Design Control: Make sure design reviews have an independent reviewer who is truly independent. Hope this helps!
Secure BioMed Evaluations
Biotechnology
Woodstock, GA 553 followers
Regulatory and Quality compliance experts
About us
Secure BioMed Evaluations provides Quality, Project Management, Regulatory, and Technical support for the Medical Device and Biologics industries. Secure BioMed Evaluations offers services ranging from consultation on specific challenges to full design control and Quality System Management. Secure BioMed Evaluations is committed to assisting you in bringing your device or biologic to the market and ensuring continued regulatory compliance for your organization.
- Website
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http://www.securebme.com
External link for Secure BioMed Evaluations
- Industry
- Biotechnology
- Company size
- 11-50 employees
- Headquarters
- Woodstock, GA
- Type
- Privately Held
- Specialties
- Medical Devices, Biologics, Quality Systems, Regulatory Affairs, Design Control, and Quality Assurance
Locations
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Primary
Get directions
7828 Hickory Flat Highway
Suite 120
Woodstock, GA 30188, US