tag:blogger.com,1999:blog-65967869733414559.comments2022-03-27T03:29:21.776-04:00Validation and Regulatory Compliance for Life Science ProfessionalsQPharmahttp://www.blogger.com/profile/03480077794386318381noreply@blogger.comBlogger74125tag:blogger.com,1999:blog-65967869733414559.post-77965093716740847402011-06-03T11:30:10.729-04:002011-06-03T11:30:10.729-04:00That is going to be highly dependent on the nature...That is going to be highly dependent on the nature of those medications and the GE animals. For the most part, industry has tried to make GE animals that are in most respects similar to their natural counterparts except for one or two differences. In the case of the salmon, it is the rate of growth, not even the extent (size). So I don't see the introduction of human medication contamination being of particular concern any moreso than it would be for the natural population.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-65967869733414559.post-4901712698259508202011-05-17T05:41:44.110-04:002011-05-17T05:41:44.110-04:00Hey Man ! I just went through complete post writte...Hey Man ! I just went through complete post written by you and found it very much useful for me..thanks for sharing . I am looking for more good things from your side.digital signatureshttp://www.arx.com/digital-signaturenoreply@blogger.comtag:blogger.com,1999:blog-65967869733414559.post-51672124978225357982011-04-04T15:38:46.476-04:002011-04-04T15:38:46.476-04:00Concerns have arisen about the amount of medicatio...Concerns have arisen about the amount of medications and their residues (Triclosan and Prozac to name a few) being found in American municipal water systems. Should such ramifications be included when discussing the adoption of trans/intra/cis-genic substances in addition to the possiblity of altered organisms escaping into the wild?Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-65967869733414559.post-28592144115018398992011-03-25T00:14:52.583-04:002011-03-25T00:14:52.583-04:00Can you give some links that can give proceedings ...Can you give some links that can give proceedings update on this breaking news about FDA will begin auditing pharmaceutical companies electronic recordkeeping capabilities to evaluate the industry’s compliance with 21 CFR Part 11 What were proceedingsdigital signature certificatehttp://www.arx.comnoreply@blogger.comtag:blogger.com,1999:blog-65967869733414559.post-40706457951178447652011-03-21T06:08:28.435-04:002011-03-21T06:08:28.435-04:00Personal Shopping is just like an occupation where...Personal Shopping is just like an occupation where you get lots of suggestion. Now days online shopping is become more interesting. There are lots of website which provide online shopping services.Yahoo Japan Auctionhttp://googlefive.com/noreply@blogger.comtag:blogger.com,1999:blog-65967869733414559.post-60728199266943459052011-03-15T13:50:49.973-04:002011-03-15T13:50:49.973-04:00There are a couple of big "gotchas" here...There are a couple of big "gotchas" here. First, these companies will need design controls and have developed their software under those controls; while 21 CFR 820.30 generally exempts Class I devices from design controls, the gotcha is that software is ALWAYS subject to those controls. Few of these companies are going to understand FDA's requirements for design controls.<br /><br />Secondly, many of these firms outsource the development of these programs to another firm, even overseas firms. Those firms may ALSO be required to register with FDA and maintain design controls as a "specification developer." You can bet that these software design and coding firms have no idea about FDA registration or requirements.<br /><br />This has been coming for years, ever since FDA's controversial Patterson warning letter (in which FDA declared their office automation product Eaglesoft to be an "unclassified" medical device even though the legal definition of that term deals with devices already on the market before 1976), and last year CDRH's John Murray alluded to this new regulation when he said that FDA would start treating many healthcare-related software applications as "medical devices."<br /><br />Less clear is the status of software that does MDDS-type things, but for a manufacturer rather than a practitioner or patient. For example, how about a device manufacturer whose software imports scans from a hospital's MRI machine and uses them to make a custom implant; or the drug company that custom-compounds a drug based on the patient's blood chemistry results transmitted from a clinic? These are clearly MDDSs, but are not themselves "marketed" and so are not subject to the new listing requirements. Does FDA have another new regulation waiting in the wings?Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-65967869733414559.post-91774254484277707592011-03-09T23:39:58.856-05:002011-03-09T23:39:58.856-05:00Oh' I never knew about this New FDA regulation...Oh' I never knew about this New FDA regulation for Medical Device Data System. Thanks for sharing this informative post. I am well updated.<br /><br />-mel-electronic medical recordshttp://www.acrendo.com/noreply@blogger.comtag:blogger.com,1999:blog-65967869733414559.post-30554909225238948722011-02-21T10:42:59.879-05:002011-02-21T10:42:59.879-05:00How interesting. Looks like all signatures will so...How interesting. Looks like all signatures will soon be replaced by digital files and add-ons. Things will definitely move faster when we can use those tools.digital certificatehttp://www.arx.comnoreply@blogger.comtag:blogger.com,1999:blog-65967869733414559.post-23731322547939110372011-01-05T17:25:04.311-05:002011-01-05T17:25:04.311-05:00Simon,
As mentioned in the blog a Risk Assessment ...Simon,<br />As mentioned in the blog a Risk Assessment is a key component to any LabWare LIMS (and other LIMS) implementation and as you mentioned any system implementation that may fall under regulatory compliance to minimize risk and determine the level of testing and any necessary corrective actions to minimize risk. In the example of customization to include a SAS interface this would most likely be considered a high risk and require a high level of validation since the interface created to include SAS would not be considered 'out of the box'.Kimberly Stantonnoreply@blogger.comtag:blogger.com,1999:blog-65967869733414559.post-31996134578417931412011-01-05T17:13:16.685-05:002011-01-05T17:13:16.685-05:00Jagidish,
Yes, when I mentioned 'Regulatory Re...Jagidish,<br />Yes, when I mentioned 'Regulatory Requirements' within my post it was meant to cover various Regulations any given LIMS implementation may fall under. <br />If you would like to discuss this in further detail please feel free to contact me at kimberly.stanton@qpharmacorp.com<br /><br />KimKimberly Stantonnoreply@blogger.comtag:blogger.com,1999:blog-65967869733414559.post-10061750552266443452010-12-23T11:05:40.324-05:002010-12-23T11:05:40.324-05:00Like all validation it should be applied at a leve...Like all validation it should be applied at a level appropriate to the risk. With LIMS apart from the core software and the hardware/infrastructure it resides on evrything is at the very least configured and there may even be some customization if SAS is applied for example.<br /><br />my advice is to 'map out' where the risk is and apply the appropriate level of validation and compliance to meet the business and regulators needs.Simon Gillishttp://www.linkedin.com/groupAnswers?viewQuestionAndAnswers&discussionID=38243739&gid=1117027&trk=NUS_UNIU_SHARE-grpnoreply@blogger.comtag:blogger.com,1999:blog-65967869733414559.post-48048817735405471572010-12-23T11:04:24.618-05:002010-12-23T11:04:24.618-05:00In addition, it should comply to 21CFR11 & pre...In addition, it should comply to 21CFR11 & predicate rule, no?Jagdish Patelhttp://www.linkedin.com/groupAnswers?viewQuestionAndAnswers&discussionID=38243739&gid=1117027&trk=NUS_UNIU_SHARE-grpnoreply@blogger.comtag:blogger.com,1999:blog-65967869733414559.post-85517933233832958202010-12-16T16:54:55.178-05:002010-12-16T16:54:55.178-05:00Congrats Alexis !!!Congrats Alexis !!!Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-65967869733414559.post-54167680939159367482010-12-03T08:54:06.915-05:002010-12-03T08:54:06.915-05:00Great Blog...many MD&D companies have become l...Great Blog...many MD&D companies have become lax in their responsibility to the patient and the individuals that provide care to those patients. It is an important topic. Thank youMarchell Norrishttp://www.linkedin.com/groupAnswers?viewQuestionAndAnswers&discussionID=36465609&gid=60035&commentID=27093412&trk=view_discnoreply@blogger.comtag:blogger.com,1999:blog-65967869733414559.post-54378895270145628392010-12-03T08:52:26.399-05:002010-12-03T08:52:26.399-05:00In legal terms, will professional ethics trump NDA...In legal terms, will professional ethics trump NDA and are there legal precedents?<br /><br />I would be intrigued to know the legal position of someone like Cheryl Eckerd, in the context of breaching a Mandatory Non-disclosure-Agreement, which she must have signed at some point during her employment.<br /><br />I can visualize a claim for misrepresentation, pecuniary gain outwith the interests of the Company and information theft - which are certainly discountable morally - but legally?Geoff Duke MSaRS CSQE (ASQ)http://www.linkedin.com/groupAnswers?trk=view_disc&gid=101930&commentID=27231730&viewQuestionAndAnswers&discussionID=36465735noreply@blogger.comtag:blogger.com,1999:blog-65967869733414559.post-88486851942801896192010-11-22T08:41:12.213-05:002010-11-22T08:41:12.213-05:00This article is so readable! You make Project Mana...This article is so readable! You make Project Management to be more interesting and understandable.<br /><br />Hope to hear more from you soon. Thanks for sharing!Nathaniel @ project management testhttp://www.pmtrainingonline.com/site/1648622/product/proj_51_a00_bs_enusnoreply@blogger.comtag:blogger.com,1999:blog-65967869733414559.post-60288950502127456652010-11-09T15:19:36.217-05:002010-11-09T15:19:36.217-05:00Wait! This couldn't have been written by Fieg...Wait! This couldn't have been written by Fieggen - no one brought chaos into King Arthur's dining hall... and when did Gwilym roll for initiative?Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-65967869733414559.post-64155855204434602852010-11-07T18:01:29.606-05:002010-11-07T18:01:29.606-05:00Thanks for all your comments, those posted here an...Thanks for all your comments, those posted here and those sent to me personally. I will take them to heart to make the story more enjoyable for all.<br /><br />To answer Ellen's concern, the excerpt shown here is not the first section of the book. It is four separate sections of the first chapter. Those sections are specific to the first tool: The Charter. In the novel I am currently working on a prologue that introduces the main female character before we even meet Gwilym. <br /><br />Thanks for reading,<br /><br />Bruce <br /><br />Bruce.Fieggen@qpharmacorp.comBruce Fieggennoreply@blogger.comtag:blogger.com,1999:blog-65967869733414559.post-74324505328966210242010-11-03T22:54:50.926-04:002010-11-03T22:54:50.926-04:00Great minds do think alike! I am glad to see that ...Great minds do think alike! I am glad to see that you have used one of the things that set you apart and transformed your passion for PM into this beautifully written quest... I look forward to more!<br /><br />Founder of LVL, LLCAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-65967869733414559.post-37603163745286632512010-11-03T15:48:32.074-04:002010-11-03T15:48:32.074-04:00Very good...intriguing. And I like your writing s...Very good...intriguing. And I like your writing style!Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-65967869733414559.post-90476445320348707772010-11-02T13:24:31.480-04:002010-11-02T13:24:31.480-04:00Bruce, Great start! Your writing holds interest we...Bruce, Great start! Your writing holds interest well and makes the subject transparent. My one criticism is that women characters should be included from the very start, which will be a challenge considering your chosen time period. If anyone can meet this challenge, it's you!<br /><br />Ellen Golds<br />Golds Associates<br />goldse@optonline.netAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-65967869733414559.post-8947474463010228062010-11-01T17:24:00.328-04:002010-11-01T17:24:00.328-04:00Looking good so far, Bruce. This style would make ...Looking good so far, Bruce. This style would make the subject matter understandable even to a layman such as myself, and I'm sure would make it a lot more interesting than other books written in Project Management style.<br /><br />Tongue-in-cheek question: I assume that you've written your own charter for this book, or does it also have Royal Assent?Ian Fieggenhttp://www.fieggen.com/ian/index.htmnoreply@blogger.comtag:blogger.com,1999:blog-65967869733414559.post-36627288978818023442010-11-01T14:46:19.686-04:002010-11-01T14:46:19.686-04:00Bruce:
Most interesting. Looks like you are off ...Bruce:<br /><br />Most interesting. Looks like you are off to a god start. It reminds me of a book I read a couple of decades ago when I was the GM of a precision sheet metal fabrication house, "The Challenge" by Robert F. Lundrigan and James R. Borchert about Just in Time manufacturing. It, too, is "A Business Novel."<br /><br />Your book will be a lot larger than the 230 page paperback 6x9 I have. It will be a lot more comprehenive, too.<br /><br />Please let me know if there is anything I can do to help.<br /><br />Regards,<br /><br />Steve Goldman<br /><br />Stephen Goldman<br />Senior Consultant<br />733 S. Everhart Avenue<br />West Chester, PA 19382<br />O - 610-918-9681<br />C - 484-678-5730<br />wizard19@verizon.netAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-65967869733414559.post-70602180192177020592010-10-22T13:32:39.537-04:002010-10-22T13:32:39.537-04:00We are doing validation of SaaS application and it...We are doing validation of SaaS application and it is nothing different. We are following GAMP5 principles.Bindu Varghesehttp://www.linkedin.com/groupAnswers?viewQuestionAndAnswers&gid=92965&discussionID=32561244&sik&trk=mywl_artile&goback=.mwg_*2_1noreply@blogger.comtag:blogger.com,1999:blog-65967869733414559.post-22396609036818942762010-10-20T15:06:21.250-04:002010-10-20T15:06:21.250-04:00The approach to validating SaaS and Cloud applicat...The approach to validating SaaS and Cloud applications is just the same as any other application. The challenge is in understanding, defining and where neccesary controlling the environment in which the application is running, and mitigating additional associated risks. <br /><br />It's not really a validation issue, but a qualification issue and (as Donald Rumsfeld never said) making the 'known unknowns' and the 'unknown unknowns' known! The often promoted advantage of SaaS and Cloud Computing is that users don't need to worry about this or that - some external supplier takes care of it for you. However, validated applications need a controlled environemnt and that means a known environment. <br /><br />And if we're plugging things (and why not?) people might like to register for a webcast "Qualifying the Cloud: Fact or Fiction?" at http://www.businessdecision-lifesciences.com/TPL_CODE/TPL_AGENDA/PAR_TPL_IDENTIFIANT/279/1584-agenda.htmDavid Stokeshttp://www.linkedin.com/groupAnswers?viewQuestionAndAnswers&discussionID=32561390&gid=51823&commentID=24819818&trk=view_discnoreply@blogger.com