Search results

Complex Therapeutic System - MD with ancillary medicinal substance + systemic drug

Yes, you can combine trials. But please pay attention to the following:
- clinical research for medical products must comply with ISO 14155:2020.
- Such clinical research must be registered with the European Medicine Agency.
- contact your notifying body and see with them that before starting the clinical research, you give them the plan of the clinical research for inspection so that they can be sure that the research plan is well set.
- study in detail the points of the MDR - from Article 61 to Article 82

IATF 16949 CERTIFICATION BODIES

Çok açıklayıcı ve değerli paylaşımlarınız için teşekkür ederim.

Access Control Policy - Managing Records

Hi All,

I'm drafting the Access Control Policy in Conformio.

At chapter "4. Managing records kept on the basis of this document" it asks for the management of 2 types of Records.

one is quite clear, it demands the management of an Access Control Review register.

The second one instead is not totally clear to me, what I don't fully understand is if we need to keep a register for only tracking the privileges (access rights granted to roles or users that usually wouldn't have them) or if we need to track every single access given to all the employees on all the used applications.

Can someone suggest what should be tracked?

Thanks in advance

Best Regards

Igor

Access Control Policy - Map Job titles to User Profiles

I am drafting the Access Control Policy in conformio.

In the section 3.2, I initially have drafted the User profiles, Applications and access rights for each SW that we are using.

Then I need to map the User Profiles to the job Titles.

The question is: When mapping the Support Administrator profile, can I simply map to the Job title "mid management" or do I need to specify Support Mid Management?

What I mean is that it is obvious that the Support software administration will never be assigned to the HR Mid management, but do we need to be specific when drafting the mapping between a User Profile and a Job Title?

Will an auditor accept a high level definition?

Thanks

Best Regards

Igor

Access Control Policy

Hi All,

I am drafting the Access Control Policy in Conformio.

In the document there is a section in which I need to map the job titles to the user profiles.

My issue is that for some of the applications that we are using there are a set of pre-exisintg user profiles like for example Light Agent or Standard staff for which we do not have any users assigned to them.

In this case should I simply not list them in the Definition of User Profiles or should I list them to state their existence but when doing the mapping with the job titles say something like "No currently Job Title assigned to the profile"

Thanks in advance.

Best Regards

Igor

Audit Question Stage 1 with FDA compliance

Project Plan

Measurement Uncertainty for 17025 Accreditation

As far as ISO 17025 requirements go, there are situations where a lab does not need to evaluate and estimate MU if a published standard method is followed.

That is if you are using a standard published method or a well-recognized test method  
and if the method specifies limits to the values of the major sources of uncertainty 
and if the method specifies the form of presentation of the calculated results 
and if the laboratory follows the test method without deviation  
and if the laboratory follows reporting instructions. i,e you control the risks

Even if the above criteria are met, besides ISO 17025 requirements you need to fulfill any client and regulatory requirements; and those specified by the accreditation body (these could be best practices enforced by a professional association or a particular program).

I suggest you confirm with your accreditation body and users of the test results. For example, a client may be part of an agricultural quality scheme that mandates the MU be below a limit for contaminants in animal feed; or there may be local regulations for fertilizers that specify a decision rule including MU (e.g result plus MU must be below the threshold limit to pass).

Collated Nonconformances

The responsibility for addressing internal audit non-conformances for each clause in ISO 9001:2015 will typically fall on the employees or teams directly involved in the process or area where the non-conformance occurred. This may include process owners, quality assurance personnel, or designated individuals responsible for investigating and resolving non-conformances. The specific individuals responsible for addressing non-conformances will vary depending on your organization's structure and processes.

Question about ITIL Documentation

Although suited for ISO 2000 implementation, our free ISO 20000 GAP analysis tool can help you start your assessment. It contains many common elements with ITIL and you can find it here

ISO 20000 Gap Analysis Tool https://advisera.com/20000academy/iso-20000-tools/iso-20000-gap-analysis-tool/