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CGMP Issues

Wednesday, November 23, 2016. COTS (Commercial Off The Shelf) Software Question / Answer. Ans: Yes. The webinar addressed primarily this final stage, integrated / systems level software validation. You would do a "black box" V&V (verifying software operation by means of the hardware's operation) of hardware and software using IQ, OQ, PQs as described*, but include any information you know about the development methods and in-process test methods used in the development of the custom software. PQs - Repea...

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Wednesday, November 23, 2016. COTS (Commercial Off The Shelf) Software Question / Answer. Ans: Yes. The webinar addressed primarily this final stage, integrated / systems level software validation. You would do a black box V&V (verifying software operation by means of the hardware's operation) of hardware and software using IQ, OQ, PQs as described*, but include any information you know about the development methods and in-process test methods used in the development of the custom software. PQs - Repea...

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CGMP Issues | cgmpissues.blogspot.com Reviews

https://cgmpissues.blogspot.com

Wednesday, November 23, 2016. COTS (Commercial Off The Shelf) Software Question / Answer. Ans: Yes. The webinar addressed primarily this final stage, integrated / systems level software validation. You would do a "black box" V&V (verifying software operation by means of the hardware's operation) of hardware and software using IQ, OQ, PQs as described*, but include any information you know about the development methods and in-process test methods used in the development of the custom software. PQs - Repea...

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cgmpissues.blogspot.com

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CGMP Issues: November 2016

http://cgmpissues.blogspot.com/2016_11_01_archive.html

Wednesday, November 23, 2016. COTS (Commercial Off The Shelf) Software Question / Answer. Ans: Yes. The webinar addressed primarily this final stage, integrated / systems level software validation. You would do a "black box" V&V (verifying software operation by means of the hardware's operation) of hardware and software using IQ, OQ, PQs as described*, but include any information you know about the development methods and in-process test methods used in the development of the custom software. PQs - Repea...

2

CGMP Issues: October 2016

http://cgmpissues.blogspot.com/2016_10_01_archive.html

Wednesday, October 12, 2016. Molding Press and Tooling V&V Continued . In response to additional ques on above subject:. Is this necessary in the eyes of the FDA or other governing bodies that you have run into? Or, is running the PQ at a nominal setting acceptable by the FDA and other governing bodies? Ques: When validating a process that has many variables, are there rules of thumb to determining how many “worst case” settings or scenarios should be run? I can see how a machine could be forever in the ...

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CGMP Issues: March 2016

http://cgmpissues.blogspot.com/2016_03_01_archive.html

Sunday, March 27, 2016. TRACEABILITY (Software / Firmware). The architecture block diagrams also provide a "traceability" function, in showing the interrelationships between the code modules, the hardware, the user interface(s), the output(s), any cloud interface, etc. The US FDA states that SW V&V has to be a risk-based activity. The above form the basis of my many articles (peer reviewed), webinars and workshops on this subject. John E. Lincoln, jelincoln.com. John E. Lincoln. Friday, March 25, 2016.

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CGMP Issues: January 2011

http://cgmpissues.blogspot.com/2011_01_01_archive.html

Wednesday, January 26, 2011. 510(k) Costs Can be Misleading. 510(K) COSTS DISCUSSIONS CAN BE MISLEADING. Does any one seriously argue that many bench / functional testing, biocompatibility testing, sterilization, documentation systems, validations (including software), the other basics (including principles of Shewhart, Deming,Juran, et al) required under the cGMP quality management systems and its infrastructure, and yes, some clinical trials, should not be required? John E. Lincoln. J E Lincoln and Ass...

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CGMP Issues

http://cgmpissues.blogspot.com/2016/11/cut-requireof-your-team-members.html

Monday, November 21, 2016. Cut Down on Team Meetings. Require of your team members -. 8220; Completed Staff Work. Shimkin, GM then owner, Simon and Schuster, from “…. Stop Worrying…”, by Dale Carnegie):. What is the problem? What is the cause of the problem? What are all the possible solutions to the problem? What solution do you suggest (with rationale)? See also my website on the subject:. Http:/ jelincoln.com/GMPTop10.html. John E. Lincoln. John E. Lincoln. Subscribe to: Post Comments (Atom).

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jelincoln.com

JE Lincoln Medical Devices Regulatory Consultants.

http://www.jelincoln.com/home1.html

J E Lincoln and Associates LLC. Regulatory Affairs - Quality Systems. Medical Devices - Pharmaceuticals. Over 34 years cGMP experience. Business Success From Regulatory Compliance™. Helping companies to understand. And meet regulatory requirements -. Improved cGMP compliance through. Phone 435-840-0252 (use Skype only for prearranged calls). US FDA QS REG. What's Changed With ISO 13485:2016? Draft Guidance on Deciding When to Submit a 510(k) for a Change to an Existing Device ,.

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cgmpissues.blogspot.com

CGMP Issues

Wednesday, November 23, 2016. COTS (Commercial Off The Shelf) Software Question / Answer. Ans: Yes. The webinar addressed primarily this final stage, integrated / systems level software validation. You would do a "black box" V&V (verifying software operation by means of the hardware's operation) of hardware and software using IQ, OQ, PQs as described*, but include any information you know about the development methods and in-process test methods used in the development of the custom software. PQs - Repea...

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