New Proposed Auditing Course: Considerations for an eData Quality Audit Program

We’ve submitted this course proposal for the April SQA Quality College in Anaheim. Feedback has been good, but even if it isn’t picked up for this venue…it will eventually happen *somewhere*:

Instructors: Timothy J. Kuhn and Conrad Kawaguchi

Target Audience: Seasoned Auditors with little eData/CSV experience or CSV professionals with little auditing experience.

 Course Objectives

• Establish and differentiate between the eData Audit Function and the Operational CSV Quality Roles.

• List the considerations for the GxP eData Audit Program (Contributing to other GxP Audits, Independent Focused Data Integrity Audits, etc.)

• Explore the various roles that the eData Auditor may serve as part of an audit (SME, Co-Auditor, Audit Lead)

• Define and list the desired skill set for the eData Audit Team

• Break down the various types of audits and risk areas for each: GLP Labs, Central Clinical Labs, Central Readers (eCG, Imaging, etc.), ePRO (Electronic Patient Reported Outcomes – AKA Diaries), Acquisition Due Diligence, GMP Manufacturing Sites and Vendors, PV, eSystem Validation, Databases, IT Infrastructure, Cloud Providers, Software Providers, SaaS vendors, Pharma, Device, Combo Product, and others.

Course Description: Electronic Data (eData) is pervasive in the GxP world and auditors in that GxP eData space need to understand what is most important in these areas. This course will explore considerations in establishing an eData audit program, give auditors with little Technology/eData/Computer System Validation(CSV)/IT saavy the understanding needed to assess the eData/eSystems they encounter in the course of their existing GxP audits, and expand the understanding of eData auditors beyond the software vendor audit so as to know what is most important in GxP audits. The course will demonstrate “what to look for” for a variety of audits, both technology-focused and more conventional areas in which technology has “encroached”.



Computer System Validation (CSV) Audit Mindmap

As a break from writing, I finished the first electronic version of my CSV Audit Mindmap. The intent is for it to be a mental tickler during an audit. Rather than 10-20 pages of checklists, this would be a visual layout of related topics that fit on 1 or 2 pages (or more if you like). Click the link to look at a pdf version…and be sure to let me what you think.

CSV Audit Mindmap




SQA Abstract – Impact of eSystems, etc.

I’ve submitted this abstract to the SQA for their annual meeting in April and am really hoping it is accepted. A very similar one that I posted last year was not….but this year, it seems that this sort of stuff is on their “hot topic” list. Fingers crossed.


The Impact of Electronic Systems, eHRs, and eData on Clinical Research

Although the use of electronic data in the pharmaceutical industry is by no means a new phenomenon, its impact has evolved over time. Technology has revolutionized our lives in many ways; in the way we access information, in our entertainment, in the way we do business, and in the way we interact. This technological revolution has had very pronounced impacts on the GxP industries: eRecords, eData, eSignatures, Data Processing, Data Mining and the Regulatory Standards associated with them.

These impacts have been most apparent in the cGMP and GLP areas and there is a fair level of comfort with eData and Validation in those areas. Increasingly however, the impact of eData and the need for controls around its use can be seen in the GCP area. Due to its large reliance on external sources of data, Clinical Research has some unique challenges. This session will cover:

I. Technology in Pharma and Validation Overview: a discussion of these concepts (which are widely felt to be cGMP artifacts) and relating them to the GCP area through analogies.

II. Centralized GCP Technology: The use of centralized eData and eSystems, primarily on the “sponsor side” has some unique challenges due to very short timelines and the external nature of clinical data inputs. Also the challenges of study-specific validation activities will be addressed.

III. De-Centralized GCP Technology – “Technology at the Clinic”: The advent of electronic Health Records (eHRs) has had a profound impact on Clinical Research and the way in which source data is handled, however the adoption of eHRs has been uneven, piecemeal, and largely independent of any research concerns . Resultantly, source data at clinical sites varies widely in format, from purely paper systems through purely electronic integrated source systems. However, a large and growing number of sites use a hybrid paper/electronic model with various sources of data, scans of source destroyed by hospital systems, paper notes, dictated notes, email notifications, and central sponsor data collection systems. Some ideas on how to address various hybrid source data scenarios will be presented.

Level: Basic Validation, Intermediate Clinical
Key Words: GCP, Electronic Data, Hybrid Source, Validation

Fundamentals of Quality

I’ve gotten some questions of late that have had me thinking about the core of what I do; fundamental questions as to what it is and why. This is a good thing and I feel that now is a good time to till this fertile soil and see what can be learned (or remembered).

Over the next few weeks, I plan to explore these ideas in a series of posts. I’m planning on submitting an abstract or two to the SQA conference and this will be a good stepping-off point to get that effort underway. I plan to present on a subfield in which I am working very heavily in my current role; Clinical System Validation. That is, Computer System Validation for the Clinical (GCP) arena within the greater pharma landscape (pharma, medical devices, and related industries).

In any case, its been too long since I’ve added some really good content here. Keep your fingers crossed that I’ll be able to put up something useful, interesting, or both.



sqaThe Society of Quality Assurance is a great professional society for those of us working in Quality Assurance, etc. in Pharma and related industries. I just received email notification that the Quality Assurance Journal from April is now online……This is the one that contained all the abstracts from the annual meeting. A bit slow to move from print to electronic, but I suppose better late than never:

Quality Assurance Journal Volume 12, Issue 2 Content Alert
Dear SQA Colleague:

The Quality Assurance Journal, Volume 12, Issue 2 is now available online! To access the content, please log into the SQA members-only website at and visit the My Membership page from the menu at the top. The link to the Journal is available on the right side of the page under Publications. SQA Members do not need a separate login to access the Journal through the SQA website. The content listing for this issue is available below. All paid members of SQA receive an online subscription to the QA Journal, included with membership in SQA. If you are interested in contributing to the Journal, please review the information regarding submissions available on the SQA website.

We hope you find this information useful.


Elliott Graham, RQAP-GLP, Executive Director

Allison Travis, Program Director

Society of Quality Assurance
154 Hansen Rd, Suite 201, Charlottesville, VA 22911 USA
Phone – +1.434.297.4772 Fax – +1.434.977.1856
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Additionally, I would encourage any Quality professional (in the Pharma or related space) who does not yet belong to SQA to consider joining. You can learn a lot and remind yourself of things you already know.

Oh, I nearly forgot. There is also an SQA group on LinkedIn. I encourge you to join that as well.


Not a real blogger?

When I first started this blog up, I was flattered that Shel Israel picked up on it. He was excited to find a real Pharma blogger. He actually wanted to interview me for some project or other he was working on, but his interest fizzled as he saw how my blog developed. It wasn’t the content (at least I hope it wasn’t), rather it seemed that he had hoped that it would be a real-time interaction, that I would post often and with reckless abandon, that I would name names, and put it all out there.

Shel (if you’re reading this and I’m sure you are since I linked to you), let me remind you:  I work in PHARMA….And to add to that, I work in one of the most sensative areas of any Pharma company, Quality Assurance – I handle our dirty laundry. Maybe that’s why you found my blog so intriguing at first, you thought I was going to put it out there anyway. Maybe I’m overstating your disappointment. You’re a busy guy (I know, I follow you on Twitter), but I think I’m at least 80% right on this.

Enough picking on Shel. He’s not alone in his disappointment. Pharma, being subject to what is arguably the most demanding body of regulation of any industry, will continue to frustrate the Web 2.0/interactive social media evangelism/technologist/Twitterite set. Pharma is conservative. Pharma is a late adopter of new technologies and paradigms.

Pharma is very, very gun-shy about being served by a regulatory body, fined, demonized, sued, condemned by congress, or otherwise censured. I have former colleagues who have had to testify before congress about questionable clinical data…not a fun time and I’d like to avoid the experience (at least in that context)

So in conclusion, maybe I’m not a real blogger. Maybe I’m a self-edited, self-published, web columnist who publishes on a very sporadic schedule…that’s a mouth full. I guess I’ll just call myself a pseudo-blogger. And I’m ok with that…at least for now.


Inadequate testing?

And this dear readers, is why we test our software….

Crash-alert system for Metro trains continues to fail
Examiner Staff Writer
July 15, 2009

From left: D.C. Councilman Jim Graham, Metro General Manager John Catoe, NTSB board member Deborah Hersman, Tri-State Oversight Committee Chairman Eric Madison and Federal Transit Administrator Peter Rogoff are sworn in before a House panel. (Examiner)
Metro’s alert system continues to fail periodically in the area of track where one Metro train crashed into another last month, killing nine and injuring more than 70 people.
A component of the automatic train alerting system that may have failed to prevent one train from knowing another was stopped ahead on the track continues to flicker intermittently in that same spot even when new equipment is used, National Transportation Safety Board member Debbie Hersman testified Tuesday. The device removed just five days before the crash as part of routine maintenance doesn’t fix the problem, either.
The revelations were part of a three-and-half hour congressional oversight hearing in which officials testified about the deadly June 22 crash and the transit system’s overall funding shortages and lack of regulation.
The continuing problem at the crash site is why Red Line riders are still experiencing delays along the line more than three weeks after the crash.

Inexplicable failures of software happen.