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
Web Site | Privacy Policy | Send to a friend | Unsubscribe

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.


Super Busy

My time has been largely booked with work. Travel has been quite extensive. In-house projects have been non-stop. As a result, there hasn’t been much time left for discretionary writing (i.e., this site). There is a light at the end of the tunnel, however.

Our HR group has posted a new position for our group (and another has tentative approval for 3rd/4th quarter). If you have any interest in Celgene, stop by the website and look in the Careers section…or drop me a line (my email address is in the comments below).

Bringing on more resources will definitely help out and hopefully clear some time for some writing. I’ve been thinking about a good number of topics that would make good discussion points. With any luck, I’ll have them up here soon.


The glass is half full/empty?

As a QA professional I scrutinize the systems, processes, and results (data) of my client groups (the operational areas….i.e., the people who do the real work). This can be very frustrating for people; especially those who work hard, do good work, and aren’t used to having someone doubt them or subject them to the third degree….physicians often have a particularly difficult time with this.

I understand this and strive to make my intrusion on their daily work as unobtrusive as possible. I also try to explain to them exactly what my thought processes are and the rationale for my questions. One of the things I like to tell my client groups/auditees is that I am an optimist who’s paid to be a pessimist. That’s simple and to the point and it seems to convey my position to my client groups/auditees rather well.

More accurately, I’m an optimist who’s paid to be the exact right combination of the guy who sees the glass half full, the glass half empty, and the cracks in the glass. They pay me to see the good, the bad, and the ugly; to take a good system and try and break it…..just to see if someone can.

Below, I’ve assembled a few (real) scenarios that I think illustrate my role:

1) In this case, I was auditing at a Clinical Investigators site (a doctor’s office). At one point in our exit interview he felt that I (a non-physician) was questioning his medical opinion. To which I told him, “I would never question your medical opionion; I’m not qualified…..but based on your source notes, I can’t tell what your medical opinion was….or even that you had one”. Understanding stole across his face…..Documentation. That’s what was missing. He was doing the work in a stellar fashion,  but not documenting it sufficiently.

2) Another physician was less convinced of the need to explicitly document his diagnosis. “Any clinician would immediately have the same diagnosis…its self-evident!”. Again as a non-physician, I told him that I was sure he was right, but that FDA would likely send a “non-clinician”; someone who would look at his documentation in a manner more akin to that of an attorney than of a medical professional….”Oh, I think I understand what you’re telling me now.”

3) A third physician tried to correct me on calling study participants “subjects” rather than “patients”….”subject sounds so cold and uninvolved”. To this, I explained my position that a “patient” is someone who comes to a doctor looking for something tried and true to make them better. A study “subject” is someone who is taking a gamble out of philanthropy, desperation, or a combination of both….someone that, with their informed consent, we are putting in some measure in harms way. They deserve our highest respect and greatest level of care. Patients are very important; study Subjects are doubly so. This doctor seemed a little irritated at my little philosophical tirade (short though it was), but he seemed to understand the point I was making…I guess he thought I was an idealist of some sort…

4) While meeting with a team that was conducting validation testing on  a clinical computer system, some on the team were frustrated by the level of testing that I was recommending (requiring?). “Well in an ideal world, we would test everything…..”….I had to correct him, “In an ideal world, software testing wouldn’t be necessary because everything would work right out of the box in a perfect and unqualified way…We test our software to ensure that it is actually working like we think it is”. He didn’t like that response, but at least he was quiet”.

Are there any others with anecdotes or questions relating to GxP?