Medical Device Validation 510K and the importance of your suppliers being fully conversant and compliant with all the regulatory obligatory requirements has become a rather burdensome load for some companies and an unacceptable load for others. However: the growing expectation is that these subcontractors will; step by step, increase their cGMP compliance level.
This continuing upsurge in subcontracter cGMP compliance must result in the industry becoming familiar with the authoring, reviewing and approval of the full suite of cGMP document. Documents such as: IQ,- OQ, - DQ, - PQ,- VRA,- VP, - URS, were born.
Whether Just completed a supplier assessment, how important was your documentation? How important was your justification for your decision? Have you been biased in your judgement? Were your priorities right? How did you get it so wrong? These are questions that are in the minds of all persons affected by an adverse audit outcome. To make certain that you are going to be ‘squeaky clean’, every question, and every answer and observation, needs to be clearly documented. The company priorities must be understood and integrated into the weighting of the 510k Pre-Audit documents. If you are auditing on behalf of a client, they have a right to review your assessment documents, and you are required to be impartial and accurate in your findings.
Assurance services involve the internal auditor's objective assessment of evidence to provide an independent opinion or conclusions regarding an entity, operation, function, process, system, or other subject matter. The nature and scope of the assurance engagement are determined by the internal auditor. There are generally three parties involved in assurance services: (1) the person or group directly involved with the entity, operation, function, process, system, or other subject matter - the process owner, (2) the person or group making the assessment - the internal auditor, and (3) the person or group using the assessment - the user.
A Medical Device Validation; pre-audit quality assessment questionnaire must cover the under listed topics but it must use a method of weighting the topics in order that the clients really critical topics have a more significant impact on the vendor’s assessment.
A medical device device is:
This definition provides a clear distinction between a medical device and other FDA regulated products such as drugs.
When goods or services are purchase by a cGMP approved organization from a none cGMP approved vendor; it is a legal requirement that the would-be purchaser audits the supplier to establish the scope of any work required to render the item or process cGMP compliant
This elevates the Vendor Audit (VA) Document to a “Must be in Place” status. So, your list of pre validation doc's must include: (VA) + (FAT) + (SAT)
These are mandatory & available as a package;