tag:blogger.com,1999:blog-10635463088953826322024-03-05T13:32:23.489-05:00Business & Decision Life SciencesIndustry News and Opinions from Business & Decision's Life Sciences experts.David Stokeshttp://www.blogger.com/profile/02209191662226254386noreply@blogger.comBlogger62125tag:blogger.com,1999:blog-1063546308895382632.post-49614825435444794462012-11-22T06:19:00.001-05:002012-11-22T06:19:54.936-05:00FDA Draft Guidance “Electronic Source Data in Clinical Investigations”The revised FDA draft guidance document “Electronic Source Data in Clinical Investigations” provides guidance to clinical trial sponsors, CROs, data managers, clinical investigators and others involved in the capture, review and archiving of electronic source data in FDA-regulated clinical investigations.
The original January 2011 draft guidance has been updated to clarify a number of David Stokeshttp://www.blogger.com/profile/02209191662226254386noreply@blogger.com0tag:blogger.com,1999:blog-1063546308895382632.post-51010586932797960252012-11-15T08:54:00.002-05:002012-11-15T08:54:57.823-05:00Penetrating the CloudIVT's Conference on Cloud and Virtualization (Dublin, 13-14th November 2012) was everything I'd hoped it would be. After two year of conference sessions simply peering into the Cloud to understand what it us, or sticking a head in to the Cloud to see what the risks are, it was good to spend two days looking through the Cloud to see how these risks can be managed and to review some case studies.
David Stokeshttp://www.blogger.com/profile/02209191662226254386noreply@blogger.com0tag:blogger.com,1999:blog-1063546308895382632.post-57010651837373549462012-11-07T04:13:00.002-05:002012-11-07T04:13:58.064-05:00Applying Anti-Virus and Automatic UpdatesAnother question from LinkedIn, which has been popping up quite a few times on-line lately. We therefore thought we'd share the question and answer with a wider audience.
Q. What are the impact of Microsoft patch upgrades on validated computer systems. How we can consider them.
A. The GAMP IT Infrastructure Good Practice Guide and GAMP 5 have good appendices on patch management, which includes David Stokeshttp://www.blogger.com/profile/02209191662226254386noreply@blogger.com0tag:blogger.com,1999:blog-1063546308895382632.post-8466101447961166442012-11-02T07:26:00.002-04:002012-11-02T07:26:36.082-04:00Collaborating on Collaboration - Validating Open Source Software
I'm delighted to hear that "Open Source Software in Life Science Research: Practical Solutions to Common
Challenges in the Pharmaceutical Industry and Beyond" has just been published (available from Woodhead Publishing and also on Amazon).
The book has an interesting history, having started life as a discussion on LinkedIn on the use of open source software in the Life Sciences David Stokeshttp://www.blogger.com/profile/02209191662226254386noreply@blogger.com0tag:blogger.com,1999:blog-1063546308895382632.post-13120928491446573122012-11-01T06:01:00.002-04:002012-11-01T06:01:40.925-04:00Retrospective Validation of Enterprise SystemsYesterday was the fourth and final stop on our virtual book tour, looking at important topics from "Validating Enterprise Systems: A Practical Guide" (published by the Parenteral Drug Association and available via their bookstore)
In yesterday's session (recording and slides available here) we looked at the topic of retrospectively validating enterprise systems including why it is important to David Stokeshttp://www.blogger.com/profile/02209191662226254386noreply@blogger.com0tag:blogger.com,1999:blog-1063546308895382632.post-71507309451206387682012-10-23T04:36:00.000-04:002012-10-23T04:43:19.451-04:00Using non-ERES Compliant Business Intelligence Tools in Support of GxP Decision MakingAnother interesting question here - this time posted in the LinkedIn 21 CFR Part 11 discussion group on the use of business intelligence tools to support GxP decision making,. However, the business intelligence tools are not 21 CFR Part 11 compliant!
Q. We are implementing a 'system' which comprises of replicating software from Oracle and a destination replicated Oracle database. The purpose of David Stokeshttp://www.blogger.com/profile/02209191662226254386noreply@blogger.com0tag:blogger.com,1999:blog-1063546308895382632.post-42647523761843652712012-10-22T05:13:00.000-04:002012-10-22T05:13:34.651-04:00Validating Clouded Enterprise Systems - Your Questions AnsweredThank you once again to those of you who attended the latest stage on our virtual book tour, with the latest stop looking at the validation of enterprise systems in the Cloud. This is in relation to chapter 17 of "Validating Enterprise Systems: A Practical Guide".
Unfortunate we had a few technical gremlins last Wednesday (both David Hawley and myself independently lost Internet access at our David Stokeshttp://www.blogger.com/profile/02209191662226254386noreply@blogger.com0tag:blogger.com,1999:blog-1063546308895382632.post-59683260647211841752012-10-17T04:44:00.001-04:002012-10-17T04:44:43.330-04:00Part 11 and "Disappearing" Signature ManifestationsAn interesting question appeared on-line today which we thought deserved airing with a wider audience via the blog.
Q. When implementing an electronic document management system, is it acceptable to
make the author/approver names and dates disappear? Is this still in compliance
with 21 CFR Part 11.50, Signature Manifestations?
A. Let's remind ourselves of the relevant rule: § 11.50 SignatureDavid Stokeshttp://www.blogger.com/profile/02209191662226254386noreply@blogger.com0tag:blogger.com,1999:blog-1063546308895382632.post-23174923250641662472012-10-08T03:49:00.001-04:002012-10-08T03:49:09.743-04:00PLCs and GAMP CategorizationHere's another interesting question and answer that we thought we'd share on-line with a wider audience:
Q. We are developing a standard template to help in identifying and classifying PLCs into GAMP 5 categories. Could you please guide us to develop the right tool for the same.
A. The 'questions' to include are relatively simple and relate to the GAMP definitions of the David Stokeshttp://www.blogger.com/profile/02209191662226254386noreply@blogger.com0tag:blogger.com,1999:blog-1063546308895382632.post-86976817660287793652012-10-05T04:14:00.001-04:002012-10-05T04:14:21.279-04:00Reflecting on 21 years of GAMPLast Tuesday saw the 21st anniversary celebrations of the GAMP Forum, now of course part of ISPE. It was a great opportunity to reflect on the history of GAMP and to catch up with some of the original founder members.
Although much of the talk was backward looking, rehashing events that led to the formation and subsequent growth of the GAMP forum, Randy Perez (current chairman of ISPE) did David Stokeshttp://www.blogger.com/profile/02209191662226254386noreply@blogger.com0tag:blogger.com,1999:blog-1063546308895382632.post-34061417504263354562012-10-04T04:15:00.000-04:002012-10-04T04:15:07.786-04:00Practical Risk Management - Webcast Follow UpThanks once again to those of you who joined us for yesterday's webcast - the second stop on our "virtual book tour" which looked at practical risk management. We had a good number of questions asked as part of the registration process which we handled in yesterday's webcast (you can watch a recording of the webcast and download the slides here) but unfortunately we didn't have time to answer allDavid Stokeshttp://www.blogger.com/profile/02209191662226254386noreply@blogger.com0tag:blogger.com,1999:blog-1063546308895382632.post-26827468744203333082012-09-26T15:32:00.004-04:002012-09-26T15:32:43.154-04:00Global Outsourcing Conference ReportOver the last three days we've been taking part and presenting at the third Global Outsourcing Conference, jointly organized by Xavier University and the US FDA.
Although not the best attended of conferences this year, it proved to be one of the best in terms of content presented and the quality of the invited speakers, including a couple of key note addresses from senior members of US FDA. ThisDavid Stokeshttp://www.blogger.com/profile/02209191662226254386noreply@blogger.com0tag:blogger.com,1999:blog-1063546308895382632.post-6673253287280863992012-09-20T04:40:00.001-04:002012-09-20T04:40:35.983-04:00Validating Enterprise Systems - Questions AnsweredThanks to those of you who attended the first session on our 'virtual book tour' - in which we looked at the some of the basics of validating corporate applications, based on the the book "Validating Enterprise Systems: A Practical Guide"
A number of people submitted questions before the webcast which we answered during the session and we also had time to answer a couple of questions submitted David Stokeshttp://www.blogger.com/profile/02209191662226254386noreply@blogger.com0tag:blogger.com,1999:blog-1063546308895382632.post-26744602147890984662012-08-29T06:34:00.000-04:002012-08-29T06:34:48.362-04:00Parameterised IQ ProtocolsAnother question from the 21CFRPart11 forum - not strictly relating to ERES, but interesting all the same:
Q. I am wondering about a project and how the FDA could see it as a validated way to execute qualification protocols.
There is the idea: we validated our document management system, where we validated the electronic signature, and the documents could be developed as pdf forms, David Stokeshttp://www.blogger.com/profile/02209191662226254386noreply@blogger.com0tag:blogger.com,1999:blog-1063546308895382632.post-81270632739273760002012-08-29T06:26:00.000-04:002012-08-29T06:26:04.905-04:00Scaleable Database Controls for Part 11 ComplianceA good question posted on-line in the 21CFRPart 11 Yahoo Group, going to the heart of security controls around Electronic Records
Q Consider an electronic record system utlizing a typical database where a User ID and Password combination are used as an electronic signature to sign the records. Assume the front end application has sufficient controls to prevent manipulation of the signatureDavid Stokeshttp://www.blogger.com/profile/02209191662226254386noreply@blogger.com0tag:blogger.com,1999:blog-1063546308895382632.post-33346514543248457282012-08-24T03:41:00.001-04:002012-08-24T03:41:24.510-04:00Measuring the Value of Validation?An interesting question today on measuring the value of validation and assigning resources accordingly - something we see very few Life Sciences organizations doing well.
Q. How do others measure the value that validation creates within an organisation?
Does anyone have any experience of assigning value to validation activities?I'm interested in how others may allocate resource and how within David Stokeshttp://www.blogger.com/profile/02209191662226254386noreply@blogger.com0tag:blogger.com,1999:blog-1063546308895382632.post-14078094429662360582012-08-23T08:25:00.000-04:002012-08-23T08:25:39.552-04:00Risk-Based Approach to Clinical Electronic Records/SignaturesQ. I'm looking at complying to regulations, in order to validate some lab software collecting data from an ICP. Anyone have any ideas on attacking this? The software claims to be "part 11 capable" but it's pretty soft. E-sigs are 'loose' and audit trails are also 'loose'. For something like this do you feel attaching a risk assessment to each part of the regs to determine what level of David Stokeshttp://www.blogger.com/profile/02209191662226254386noreply@blogger.com0tag:blogger.com,1999:blog-1063546308895382632.post-76431689264060853292012-08-22T16:02:00.001-04:002012-08-22T16:02:56.042-04:00Verifying Computer Clocks in ProductionAnother good question asked online, that we share here...
Q. In a mechanically driven process, when Time is a critical parameter, the timer would be qualified for accuracy and reliability. Probably challenged against another calibrated clock for various durations that would align with the process requirements/settings. No doubt Preventive Maintenance and Calibration schedules would be developed David Stokeshttp://www.blogger.com/profile/02209191662226254386noreply@blogger.com0tag:blogger.com,1999:blog-1063546308895382632.post-51695579568212125712012-08-22T14:52:00.000-04:002012-08-22T14:52:24.030-04:00When are e-Signatures Required?
We answer a lot of questions submitted to us by e-mail or in various on-line groups. We thought that some of these deserve a wider audience, so from now on we're going to publish the best questions (and answers) here on the Life Sciences Blog.
Q. I had a question regarding 21 CFR Part 11 Electronic records. If a system has electronic records but no electronic signature but does contain the David Stokeshttp://www.blogger.com/profile/02209191662226254386noreply@blogger.com0tag:blogger.com,1999:blog-1063546308895382632.post-59058552173136573792012-08-21T05:30:00.000-04:002012-08-21T05:30:47.741-04:00Cloud Computing Comes of Age in Life SciencesFor a while now we have been saying the Cloud was coming of age in the Life Sciences industry.
Business & Decision, along with a small number of other Providers have been providing Infrastructure-as-a-Service and Platform-as-a-Service for some time.
We also said that as far as Software-as-a-Service was concerned, we would see Life Sciences specialist vendors (e.g. LIMS, Quality David Stokeshttp://www.blogger.com/profile/02209191662226254386noreply@blogger.com0tag:blogger.com,1999:blog-1063546308895382632.post-68984025874311420352012-04-05T07:23:00.002-04:002012-04-05T07:23:57.006-04:00Social Networking in Health Sciences: Is Medical Devices Missing a Trick?In yesterday's webcast "Social Networking in Health Sciences: Is Medical Devices Missing a Trick?", we shared a good volume of information with our viewers, but unfortunately we didn't have time to address everyone's questions.We've therefore reproduced the questions below, along with our answers.Q. How precisely can advertising be targeted on a platform such as Facebook?Because platforms such asDavid Stokeshttp://www.blogger.com/profile/02209191662226254386noreply@blogger.com0tag:blogger.com,1999:blog-1063546308895382632.post-72746923810139382782012-03-30T05:43:00.003-04:002012-03-30T05:43:24.039-04:00Computer System Validation Policy on Software-as-a-Service (SaaS)
In a recent LinkedIn Group discussion (Computerized Systems Validation Group: Discussion "Validation of Cloud), the topic of
Software-as-a-Service (SaaS) was widely discussed and the need to identify appropriate
controls in Computer System Validation (CSV) policies was discussed.
The reality is that relatively few compliant, validated SaaS
solutions are out there, and relatively few Life David Stokeshttp://www.blogger.com/profile/02209191662226254386noreply@blogger.com0tag:blogger.com,1999:blog-1063546308895382632.post-84525489504176801912012-03-14T06:12:00.000-04:002012-08-21T04:26:27.233-04:00Successful and Compliant ERP ProjectsUnfortunately we ran out of time in yesterday's webcast “Secrets to Success - Plan and Implement Compliant ERP Projects”.
That was partly my fault because I was late dialing in. (Apparently, Microsoft Exchange/Outlook still doesn't automatically recognize that the US and Europe change to daylight savings on different weekends - doesn't anybody validate this software?).
My apologies for that, David Stokeshttp://www.blogger.com/profile/02209191662226254386noreply@blogger.com0tag:blogger.com,1999:blog-1063546308895382632.post-2992825034369607502012-02-22T14:02:00.000-05:002012-02-22T14:02:15.567-05:00Aggregate Spend/Sunshine Act: Change is Inevitable….are you ready?
The Comment Period for the Physician Payments Sunshine Act closed last week. Now everyone is waiting to see how it will play out and what will be included in the final legislation. We, at Business & Decision Life Sciences are no exception.
In addition to the “nuts and bolts” of the changes i.e. what payments are now to be accumulated, payments made to which parties, how Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-1063546308895382632.post-47452868655843225612012-02-17T04:58:00.000-05:002012-02-17T04:58:47.989-05:00Risk-Based Validation - How Are We Doing?Yesterday, I posted a poll on LinkedIn asking the question
"How is Life Sciences industry embracing risk-based computer
systems validation? Do we have the balance between risk assessment and risk
mitigation right? Are we just rushing to reduce costs...?"
People's responses are starting to come in and we're already starting to get some interesting comments on the question. If David Stokeshttp://www.blogger.com/profile/02209191662226254386noreply@blogger.com0