PJ Singh, PMP

PJ Singh, PMP

Total Contributions 25
Nov 16, 2017At one of Agile project, we were able to achieve 80% of automation (Regression testing)....
Nov 11, 2017Regarding security controls, it is critical to ensure monitoring and analyses of the data (log)...
Nov 10, 2017I am working with a client who is using AWS for cloud based highly regulated...
Nov 9, 2017To take full advantage, Agile should integrate development, testing and validation. SDLC should define agile...
Nov 3, 2017If the system has not yet been released and this is a non-conformance, consider one...
Nov 3, 2017Imran, BTW, I am near Princeton, NJ. PM me if you like....
Nov 3, 2017Let's me clarify an important point. It is important to assess if the system validation...
Oct 28, 2017Is it possible to route Excel as "Read only" file as attachment using your document...
Oct 28, 2017Manoj, In my humble opinion it may not be sufficient to just have technical specs...
Oct 27, 2017John, perhaps you may want to consider building QMS based on cloud based new generation...
Oct 26, 2017Carsten, i agree user stories need to be controlled, especilly considering thefact most of developers...
Oct 25, 2017I see no reason, why user stories can't be controlled as part of DoD. I...
Oct 25, 2017Hello Patric, you remember me from our time at Synthes. It is good to hear...
Oct 23, 2017Gail, I believe we should be able to manage TM between user stories (instead of...
Oct 23, 2017Don, I couldn't agree with you more. It good to hear from you. Let's connect...
Oct 21, 2017Bob, I agree with you!In my experience most Life Science companies are using Hybrid mode...
Oct 7, 2017Gopal, How would we know that non-GxP module doesn't impact GxP functionality. For example change...
Oct 7, 2017SoX control would apply to most of SAP modules (e.g. SD, MM, FI/CO). It is...
Oct 6, 2017There are number of life science companies that takes the approach of validating the entire...
Aug 8, 2017Praveen, why would the validation of HP ALM (PC) is required If we extract output...
Jul 23, 2017Lyn, I have been part of number of Agile implementations for Life Science industry. I...
Jul 23, 20174. Tools Validation: As David said, perform assessment of the tools to identify and mitigate...
Jul 23, 2017One more thing, if your testing tool is not validated, consider extracting output (e.g. TM,...
Jul 15, 2017I Agree with David Stokes. I would add that CAPA process should be used to...
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