Auditviewer App Suggestion

I agree with previous feedbacks.

I Add my own comment :

• We should be able to consult the audit throught PI SMT with the same fonctionnalities as the exisiting log viewer.

• The current app still display audit activation warning at startup when we activate partial audit (only with some modules)

• The Excel export doesn't work.

• Point Source action aren't audited. (Point source management is terrible, I add another feedback for that)

In emails with Carl and Nate Anderson, here are the problems I've identified: Major Problem: As a Quality Control Specialist for a GMP PI System, I need to be able to regularly review a report of system generated audit trail changes/deletions for the PI System (AF&PI Data Archive) and annotate with explanation of the changes/deletions so that I can support the required Annex 11, Para 9 regulation. Sub Problems: As a Quality Control Specialist for a GMP PI System, I need to manage my audit commentary system within the PI System, as I do not want to damage my data integrity with having multiple copies of data that may be out of sync and possibly risk FDA penalties if audited. As a Quality Control Specialist for a GMP PI System, I need to manage my audit commentary system within the PI System and avoid data extraction and manipulation, as I do not want to introduce data integrity concerns around manual manipulation that may risk FDA penalties if audited. As a Quality Control Specialist for a GMP PI System, I’d like a way of reviewing and commenting on my Audit Log that does not require PI Administrative access, as this introduces a security risk to my PI System. As a PI Administrator, I want to control access to audit trail review and annotation, as only certain people will be permitted to review and annotate the Audit Log, and leaving this open to all users introduces a security risk to my PI System and a possible data integrity issue for my manufacturing process that may risk FDA penalties if audited.

Major Problem: As a Quality Control Specialist for a GMP PI System, I need to be able to regularly review a report of system generated audit trail changes/deletions for the PI System (AF&PI Data Archive) and annotate with explanation of the changes/deletions so that I can support the required Annex 11, Para 9 regulation. Sub Problems: As a Quality Control Specialist for a GMP PI System, I need to manage my audit commentary system within the PI System, as I do not want to damage my data integrity with having multiple copies of data that may be out of sync and possibly risk FDA penalties if audited. As a Quality Control Specialist for a GMP PI System, I need to manage my audit commentary system within the PI System and avoid data extraction and manipulation, as I do not want to introduce data integrity concerns around manual processes that may risk FDA penalties if audited. As a Quality Control Specialist for a GMP PI System, I’d like a way of reviewing and commenting on my Audit Log that does not require PI Administrative access, as this introduces a security risk to my PI System. As a PI Administrator, I want to control access to audit trail review and annotation, as only certain people will be permitted to review and annotate the Audit Log, and leaving this open to all users introduces a security risk to my PI System and a possible data integrity issue for my manufacturing process that may risk FDA penalties if audited.

Major Problem: As a Quality Control Specialist for a GMP PI System, I need to be able to regularly review a report of system generated audit trail changes/deletions for the PI System (AF&PI Data Archive) and annotate with explanation of the changes/deletions so that I can support the required Annex 11, Para 9 regulation. Sub Problems: As a Quality Control Specialist for a GMP PI System, I need to manage my audit commentary system within the PI System, as I do not want to damage my data integrity with having multiple copies of data that may be out of sync and possibly risk FDA penalties if audited. As a Quality Control Specialist for a GMP PI System, I need to manage my audit commentary system within the PI System and avoid data extraction and manipulation, as I do not want to introduce data integrity concerns around manual processes that may risk FDA penalties if audited. As a Quality Control Specialist for a GMP PI System, I’d like a way of reviewing and commenting on my Audit Log that does not require PI Administrative access, as this introduces a security risk to my PI System. As a PI Administrator, I want to control access to audit trail review and annotation, as only certain people will be permitted to review and annotate the Audit Log, and leaving this open to all users introduces a security risk to my PI System and a possible data integrity issue for my manufacturing process that may risk FDA penalties if audited.

Major Problem: As a Quality Control Specialist for a GMP PI System, I need to be able to regularly review a report of system generated audit trail changes/deletions for the PI System (AF&PI Data Archive) and annotate with explanation of the changes/deletions so that I can support the required Annex 11, Para 9 regulation.

Sub Problem 1: As a Quality Control Specialist for a GMP PI System, I need to manage my audit commentary system within the PI System, as I do not want to damage my data integrity with having multiple copies of data that may be out of sync and possibly risk FDA penalties if audited.

Sub Problem 2: As a Quality Control Specialist for a GMP PI System, I need to manage my audit commentary system within the PI System and avoid data extraction and manipulation, as I do not want to introduce data integrity concerns around manual processes that may risk FDA penalties if audited.

Sub Problem 3: As a Quality Control Specialist for a GMP PI System, I’d like a way of reviewing and commenting on my Audit Log that does not require PI Administrative access, as this introduces a security risk to my PI System.

Sub Problem 4: As a PI Administrator, I want to control access to audit trail review and annotation, as only certain people will be permitted to review and annotate the Audit Log, and leaving this open to all users introduces a security risk to my PI System and a possible data integrity issue for my manufacturing process that may risk FDA penalties if audited.

It should also be possible to flag AF attributes or PI Tags as CPP (critical process parameter) and with this mandatory to review. Also the possibility to flag the audit trail entry as reviewed might be useful.

The ability to really focus in on the item that has changed would be very helpfull. For example, As a reviewer of the PI system audit logs it would really help if I could easily focus in on the PI tag attribute that has changed instead of getting a list of all PI tag attributes associated with that tag.

Improved filtering options would allow quality reviewers to focus in on changes they are interested in, instead of having to sort through hundreds of pages of records... they could easily find records of interest

Another idea would be the possibility to Add Audit Entries for creating values if the value comes from an manual datasource (e.g. SMT, Custom Software based on WebAPI, ...). In this case we would need a possibility to configure based on the data source.

We need to the give the Quality Assurance department the ability to use the Auditviewer off server. We would like to limit the number of people accessing the server. This is to help ensure that configurations aren't modified. Thanks.

I totally agree that the PI Auditviewer needs enhancements to increase usability and compliance. I just added this enhancement idea/request yesterday: https://pisquare.osisoft.com/ideas/29293