1. The content and inspection methods of internal audit of medical devices.
The person in charge of the enterprise shall be the main person responsible for the quality of medical device products.
2. Reference of the results of internal audit self-inspection of medical devices.
xxx is the main person in charge of the quality of our products.
3. Implementation plan for the integrated deployment of GMP ERP OA for medical devices.
3.1. There is information about the person in charge of the enterprise in the online "Job Description";
3.2 The text is embodied in the "Quality Manual", indicating that the enterprise has implemented 12.1；
3.3. Although it is the person in charge of the enterprise, the appointment letter is still indispensable, which is a necessary condition, and the online OA appointment letter will solve many problems;
3.4. This clause should add ** internal audit, and give sufficient self-examination guidelines.
Fourth, the implementation method of integrated deployment of GMP ERP OA for medical devices.
4.1. It is not important to add [person in charge of the enterprise] in the job description, after all, most small and medium-sized enterprises are bosses, but they often ignore such details, and agree to cause a lack of arms and legs.
4.2 This article is embodied in the "Quality Manual", which should be a common technique used by some more experienced third-party equipment tutors, that is, people often say how you implement GMP regulations, they directly copy the regulations in the original text to the "Quality Manual", so that you can not find faults.
4..3 Similar to the previous article, with the online OA appointment letter, although it is impossible to solve the problem of work, if you do not appoint [the person in charge of the enterprise], the actual system is difficult to find the problem, in fact, it is not, just because the appointment letter is relatively simple, or if you want to make a system of the integrity rate of the appointment letter, it is also relatively easy, of course, the premise is that there is a complete job description, if there is a job description, the system will calculate, you have this position, but there is no appointment letter.
SummaryFor advanced digital OA, it is not impossible to do further algorithm and reminder coaching, just to see if there is a need for this, if necessary, even if it is such a simple appointment letter, it can be made into a task type.
4.4. The addition of this article to the internal audit provisions is inevitable for implementation, and with the self-inspection guidelines, the goal is to make the self-inspection method a fool.
In summary, in the complete GMP and OA integrated system, 12.1. The clause should be easy to grasp.