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Ativos

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We answered it through Experta - you can find the answer here: https://experta.com/shared-post/d7a4c02b-ac63-4bd9-97aa-2578b8cca18f

ISO 27001 Internal Audits

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Automated Firewall Review

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Choose to Not implement a security control

Well explained! Thank you :) 

SOP

There is no mandatory requirement to list risks in an SOP. On the technical side, the overall risk assessment per test or calibration method should be performed according to your risk management procedure. You should, however, document specific controls in the SOPs that are put in place to keep the risk at an acceptable level. i.e. the controls decided on during the risk assessment. Ensure you state clearly if some action is mandatory. For example Shake for 10 min. Do not leave samples standing after 10 minutes, filter immediately.

For more information on risk assessment have a look at the Advisera ISO 17025 toolkit and webinars available. Start here https://advisera.com/iso-17025/

Business continuity plan, RTO and MTPD

Considering your MTPD is 2 hours and the resume of business is taking more than 4 days, then you can raise a nonconformity because recovering is taking more time than the defined MTPD.  

Documentation Hierarchy

Hi I need support to organise and map organisation documentation. How it should be organised as mandatory corporate documents

Level 1 documents

 1 Manuals
1.2 Policy
1.3 Strategy
1.4 Main Process Titles
1.5 Sub-Process

or shall we have policy first and them manuals. What is the diffrence between policy and manual?

Thanks

ISO 17025 and 22716

In all cases, the standard and regulatory body requirements needs must be met. In the case of CGMP as I understand the testing laboratory must be ISO 17025 accredited for the tests being performed. Your company needs to ensure that the laboratory results being used are valid, i.e. fit for your purpose. This includes reports that meet ISO 17025 accreditation requirements. All records must be retained as per your management system processes.

I suggest you reach out to the FDA and establish exactly what is required for stability studies.

Information Security Goals

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We answered it through Experta - you can find the answer here: https://experta.com/shared-post/ceebcd7b-9dd8-40b8-b06a-87878bcbbfab

RTO in the BIA questionnaire

Please note that the RTO is defined in the template 06.1_Appendix_1_Recovery_Time_Objectives_for_Activities_22301_EN based on MTPD (Maximum Tolerable Period of Disruption). The RTO for each listed activity should be equal or smaller than the defined MTPD for that activity.

In the template 05.1_Business_Impact_Analysis_Questionnaire_22301_EN you define the MTPD for each activity.

Included in the toolkit you have access to a video tutorial that can show you how to fill in the BIA questionnaire, with real examples, and define the MTPD.