MedicalDevice_TLB_8.25

Auditing

Available from Optim Associates, Inc.

Baseline Audits. Baseline Audits establish the “base-line” regulatory compliance health evaluation of the Quality System and documents any associated Quality System gaps.

Verification Audits. Verification Audits confirm progress against Baseline Audit findings or are used to periodically review and confirm progress against FDA enforcement actions: 483, Warning Letter or Consent Decree.

Internal Audits & Assessments. OPTIM Associates can augment audit schedules with expert resources to maintain schedules and provide independent experts to maintain compliance. As a companion to Internal Audits, a less formal Internal Assessment may be helpful to quickly provide feedback to management without the structure of an Internal Audit.

Supplier Audits. Supplier Controls are a focus of the FDA and are in the top 5 list of findings. Often times Supplier Audits don’t receive adequate attention due to lack of resources, expertise or oversight.

Quality System & Process Audits. OPTIM Associates performs audits of your entire Quality System using the FDA Guide to Inspections of Quality Systems (QSIT), August 1999. Additionally, we are building the capability to conduct Medical Device Single Audit Program (MDSAP) preparatory audits.

Preparing the entire organization for an impending FDA Inspection is critical for success. This includes, but is not limited to expected topics, expected threads, how to listen, act, react and answer questions, what to say and not say, and how to respond

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