A New Year of Spying on You and Me

Yeah, well they renewed it. This isn’t strictly related to Healthcare Innovation, but working as I do in the Pharma/Device eData space, it is of interest. Privacy comes up a lot…and this complicates things.


An illustration picture shows the logo of the U.S. National Security Agency on the display of an iPhone in Berlin






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”.




Some good stuff in this guidance….particularly the bit on True copies…..


True copy: A true copy is a copy of an original recording of data that has been certified to confirm it is an exact and complete copy that preserves the entire content and meaning of the original record, including in the case of electronic data, all metadata and the original record format as appropriate.

Full Guidance:  http://www.who.int/medicines/areas/quality_safety/quality_assurance/Guidance-on-good-data-management-practices_QAS15-624_16092015.pdf

New Draft EMEA Paper on Electronic Source Data

Source data, the original entry for data in research or manufacturing, is expected to contain certain elements of Quality in the Pharma industry. These elements are often expressed with the acronym ALCOA (i.e., Attributable, Legible, Contemporaneous, Original, and Accurate).

When the data is in electronic format, the logistics of this change somewhat, and more guidance/clarification is typically needed. The Food and Drug Administration, FDA, has ruled on electronic data as source for clinical trials in the past.

Now the EMEA, the EU’s regulatory authority has published a draft paper outlining their expectations as to the use of electronic source in Clinical Trials. They have requested comments from industry stakeholders, experts, etc. by this April.

I have worked extensively in evaluating electronic data issues, especially in how they relate to clinical research, so I am very interested to see how  how EMEA’s position varies from FDA’s. I will be reviewing this paper thoroughly and time permitting, I may include a summary here.