The audits offered by DBT include:
- QSIT audits using the FDA inspectional paradigm. DBT will begin using the new QSIT model of audit for those clients who expect nominal, or routine audits from FDA. These audits help assess the level of compliance as a function of FDA, product liability exposure and to the type of devices made. Also, they are less time consuming and expensive to conduct.
- Technical audits regarding product design, research, prototyping and laboratory testing. We pay particular attention to the validation of key analytical test methods as part of the audit process of the quality system.
- Key process validation audits.
- Key design validation audits.
- Regulatory audits conducted either before or after regulatory inspection with an eye towards corrective action determination and implementation.
- Complaint handling and Medical Device Reporting.
- Product audits as related to approval and Device Master Record status.
While audits are an important element for the conduct of your business, DBT also provides systems assessments as well. Similar to the audit there are important differences:
- Assessments provide for interaction between DBT’s assessors and company personnel.
- Assessments provide a “tutorial” approach meaning that as the assessment is conducted, company personnel are exposed to possible corrective actions.
- Provide a launch pad for Quality Systems Improvement Programs.
And don’t forget suppliers! They provide critical services from components to finished devices. The state of the QS and their ability to comply with your company’s Quality Agreement is of critical importance. DBT has experience in dealing not only with on-shore suppliers but off-shore as well. We not only provide assessments/audits of your suppliers but can work with them in bringing their QS up to an acceptable level so that you can rely on their services from the regulatory perspective. For off-shore services please click on Asia Services