Validation for Sharepoint

COMPUTER SYSTEM VALIDATION (CSV) 21 CFR PART 11
1

Hi,

We are in the process of Validating Sharepoint. Using Sharepoint Platform we have also integrated other applications like CAPA etc,

I am looking for some guidance and control points to validare Sharepoint. Can anyone help me by throwing some light on Sharepoint validations?

Regards
Shan

2

I got this just the other day. It seems to have your questions answered and it is free.

Subject: Free Webinar: SharePoint and 21 CFR Part 11 – A risk based approach to validation for regulated environments
First Webinar in our SharePoint for Pharma Series - SharePoint and 21 CFR Part 11 – A risk based approach to validation for regulated environments - April 23rd @ 1pm EST

Presented by Paul Fenton, VP Pharmaceutical Processes and Technology, Montrium Inc.

Register here:
https://www2.gotomeeting.com/register/511752778

Webinar Overview:
When used as a system for managing regulated content and processes, SharePoint is subject to the requirements of 21 CFR Part 11 and related requirements. During this session we will review the approaches being taken by companies to validate their SharePoint environments, and emerge with a set of guidelines for a risk-based validation strategy for SharePoint. You will gain a clear understanding of why, when and how to validate SharePoint, and there will be a strong focus on reducing the time, cost and resources required to validate a SharePoint environment whilst providing maximum quality, control and ROI.

Among the topics included will be:

  • Managing and validating a mixed SharePoint environment that includes both controlled and non-controlled SharePoint environments
  • Risk evaluation methods for SharePoint systems
  • A Step by Step overview of the risk-based validation process following the GAMP5 model
  • Implementing effective configuration and change control procedures for SharePoint-based systems

Register here:
https://www2.gotomeeting.com/register/511752778

3

FYI: Recorded webinar is available here:

4

Dear Sir,
Is there need for validation of all software programs in pharmaceutical company , such as HR soft ware program, Outlook for communication between each department, help desk for IT system
Although these programs are external & international software and had been purchased from specialized programming companies
& these programs not effect on the final product quality

Thanks Alot for your support

Best Regards,
Maysoon

5

HR software unless it is for documenting training, Outlook, and help desk software are not usually validated. As you stated they do not effect final product quality. Software used to make cGMP decisions, software that effects product quality, software in systems subject to GxP regulations need to be validated

6

Hi Shan,

I’m not sure if you have already completed your SharePoint validation effort. However, if you are still looking for information regarding this matter, please feel free to contact me. Our company has a Validation Pack for SharePoint which consists of all the documents necessary to be able to validate SharePoint against 21 CFR Part 11 Requirements for electronic records management. Further information about the Validation Pack can be found on our web site:
http://montrium.com/media/pdf/montrium-sharepoint-validation-pack.pdf