- Processed Based Auditing
- FDA QSR
- Warning Letter
- ISO 13485:2003
- EN MDD/93/42/EEC
Do you know if you are prepared for an FDA audit?
Are you confident that your suppliers/contractors are meeting their obligations? Are your internal processes being followed?
Many organizations do not have the time or experience to conduct audits. Many do not understand how to handle a FDA inspection. Our consultants are experienced in leading audits and managing audits from regulatory agencies and standards organizations.
Our auditing services:
- Help you prepare for an FDA Inspection
- Develop your internal and supplier program
- Will serve as your Internal Audit staff (contracted)
- Conduct Gap Analysis
- Manage your ISO certificate audits
- Conduct follow-up audits to Corrective Actions for Warning Letter improvements
- Are conducted in accordance with MDD, ISO 13485,and QSRs
- Will conduct Supplier/Contractor audits. We give you confidence that your suppliers are meeting their commitments.