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”.

 

~TJK

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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.

~TJK

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

SQA

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 http://www.sqa.org 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.

Sincerely,

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.

~TJK

SQA Abstract – Clinical eData

I’ve submitted an abstract for the Society of Quality Assurance conference this April (right at the Oct 14th deadline). I should hear back by the end of November. I’m not sure if it will be accepted as a full session or as a single presentation (or at all really), but I’m pretty excited about it. I’ll be giving a similar presentation internally at Celgene as part of ongoing training that our group provides, so a lot of the work for it is already done.

The Impact of Electronic Systems and eData on Clinical Research

Abstract
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”: 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.

~TJK

SQA Thoughts after Catching Up on some Work

They say that no good goes unpunished….That goes doubly for attending a week-long off-site conference/training. I’ve been back from SQA for over two weeks now and am just getting to a place that might be called “caught up”.

Overall, the conference was good. I had some time away from the office to recharge, reflect, and learn. I saw some old friends and met a few new ones. The pre-conference train courses were quite good:

1) Basic GLP – Pre-clinical is an area in which I haven’t worked directly and I think it is best to always stretch at these opportunities and learn something new. I came in second in GLP Jeopardy!

2) Current Topics in GCP (formerly entitled Advanced Topics in GCP) – This is one of the areas in which I currently live and breath; so I heartily enjoyed this session. It included several former/current FDA employees who really added a lot to the course and the subsequent discussions.

During the conference proper, I focused primarily on Clinical and Validation sessions. There were a lot of good ideas and questions at these sessions too, but I really find that I get a lot more out of the intimate, all-day training classes because of the opportunity to really drill down into a topic and explore lots of related ideas and experiences.

Anyway, I’d better get back to it. I’ve been implementing a training program at work related to “Good Documentation Practices for Clinical Validation Projects” that has been taking quite a bit of time. It has generated a lot of good discussion and the response has been very good. Time permitting, I may post some of my support materials.

~TJK

SQA Conference

This weekend, I leave for the week-long SQA conference in Memphis, TN. SQA is the Society of Quality Assurance (www.sqa.org), an organization of Quality Assurance Professionals in the Pharmaceutical (and related) industries. I didn’t make it last year, but I’ve been several times in the past and its usually a really great conference for training, sharing ideas, and “re-centering” away from the store, so to speak. We QA people spend a significant portion of our lives clarifying what it is we do…Its nice to spend some time with people  like Don Barzini (in The Godfather) who “don’t need to be told”.

I’m going to be taking a couple of pre-conference training courses, one on basic GLP (which I haven’t done directly in my career) and another on current (advanced) topics in GCP. I had hoped to present this year (probably on the use of Technology in Clinical Research), but with the job change and such, there really wasn’t time to prepare anything….and it was unclear whether I’d be able to go until about a month ago. Next year for sure.

I’ll try to post an ongoing log of my experiences at the conference and associated commentary. Perhaps it will be of interest to those are unfamiliar with the conference or those who just can’t make it this year (budgets being particularly tight at a number of Pharma companies at this point).

~TJK