Regulatory Agency and Notified Body Quality System inspections and audits can, if significant shortcomings exist, lead to delayed product clearances, importation bans, product recalls, or even legal action.
One way of helping to avoid such potentially damaging results is to have an independent pre-inspection review – especially important if your first formal compliance audit is approaching. When carried out by experienced consultants, pre-inspection review are the ‘gold standard’ of preparation, not only identifying any weak or non-existent areas of compliance, but also ensuring your staff gains valuable audit experience.
If your company has already suffered from recalls or import bans, a positive regulatory agency audit may be necessary before normal business can resume. Again, external review of your revised quality system prior to formal inspection can pay dividends.
GEMARMED has extensive experience of quality system auditing and can offer an effective pre-inspection review program to ensure the successful completion of your next regulatory agency audit. Feel free to contact us and see how we can assist.