Hello Vicki,
Here are some of our experience with using MS products as eQMS. We have been using SharePoint platform with Office365 integrated:
Advantages:
1. Cost effective implementation
2. Quick In-house solutions / experts to modify workflows
3. Simple workflow process
Challenges:
1. E-signature cannot be implemented easily with part 11 compliance due to poor track of audit history
2. Documents will most likely be in word or excel format instead of approved PDFs
3. Extended configuration / customization efforts requiring increased validation / testing efforts
If you would like to know further, please reach out to me (
loganathan.k@zifornd.com)
Thanks,
Loga
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Loganathan Kumarasamy, MS RAC
Senior Consultant
Waukegan IL
United States
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Original Message:
Sent: 02-Jul-2020 19:29
From: Vicki Gail
Subject: Microsoft (MS) with app/add-on's for eQMS?
Hello Loga,
I have been told that our Quality Department is looking at using Office 365, specifically Sharepoint/Onedrive/Teams/PowerPoint and possibly BPA solutions.
Thanks,
Vicki
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Vicki Gail
QA / RA Manager
Agoura Hills CA
United States
Original Message:
Sent: 26-Jun-2020 10:16
From: Loganathan Kumarasamy, MS RAC
Subject: Microsoft (MS) with app/add-on's for eQMS?
Hi Vicki, Which platform are you planning to use within Microsoft?
Thanks,
Loga
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Loganathan Kumarasamy, MS RAC
Senior Consultant
Waukegan IL
United States
Original Message:
Sent: 25-Jun-2020 13:50
From: Vicki Gail
Subject: Microsoft (MS) with app/add-on's for eQMS?
Hello again fellow RegX members!
Our company is considering using a Microsoft (MS) platform with app/add-on's for as an electronic quality management software system (eQMS). Would anyone be willing to share any experiences using MS for eQMS and any 21 CFR part 11 challenges you encountered as a result?
Thank you in advance.
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Vicki Gail
RA Manager
Agoura Hills CA
United States
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