Articles & Posts

The Daily HaiQu

Most of the articles I publish to the
Daily HaiQu
mailing list are posted
here
. There are more than a year's worth of posts there now!
Of course, the best way to enjoy the newsletter is to
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Here are some highlights that I've combined under specific topics:

Encapsulating Spreadsheet Functionality into Discrete, Testable Modules

person holding black corded device
Posts started from:
13-Nov-2023
Separation of concerns is a design principle in computer science whereby a computer program is separated into distinct parts that each address a different aspect of the program. The basic goal is to modularize a program. In this set of articles we explore this concept in relation to building spreadsheets for critical data analysis tasks.

Managing Spreadsheet Templates, Instances, Versions and Revisions

black and silver smart watches
Posts started from:
24-Oct-2023
A spreadsheet is like a document in that all of the content - data, format and functionality - is kept in one file, so it's easy to just email it around the team for review and revision. This results in many copies to track. In these articles I talk about managing spreadsheet files throughout their lifecycle: Templates, Instances, Versions and Revisions.

Is a spreadsheet the right tool for the job?

Statue of David
Posts started from:
16-Oct-2023
You can really do almost anything within Excel. But should you? When is a spreadsheet the appropriate tool to use, and when should we be looking for something else?

User Requirements for Mission-Critical Software

grey metal parts
Posts started from:
12-Apr-2023
We’re so used to window shopping - or I guess the modern equivalent is “swiping” - that we tend to do the same for mission-critical software and equipment. We look for features, brands, and deals rather than being explicit about what we actually require. This can mean we end up getting something that doesn't quite fit our needs. An expensive problem indeed.

The Boundary Law and its Application to Complex Systems

Corals under water
Posts started from:
12-Jan-2023
This post we’re going to talk about boundaries, and make some observations that help us develop strategies for designing, analysing and troubleshooting complex systems.

What's the difference between Backups and Archiving Electronic Data?

Movable shelves in an archive
Posts started from:
24-Dec-2022
In this post we're going to look at two activities: Archiving and Backup. Both of these activities are mandated by regulations and quality systems, often mentioned in the same paragraph. What exactly is the difference between archiving and backup when it comes to electronic records? Can't a backup of electronic data just be labelled as an archive?

Why Would You Want to Validate a Spreadsheet?

Person holding a black iphone
Posts started from:
6-Dec-2022
Why would we want to validate a spreadsheet, regardless of the compliance requirements? What do we get out of the deal?

Longer Articles

Here are some longer articles that I've written over at my
Good Practices
blog.

Updates to the OECD GLP Working Group's Frequently Asked Questions

Posts started from:
17-Jul-2020
The OECD GLP Working Group has added new items to their frequently asked questions (FAQ) page for GLP. This is my opinionated take on this year's additions to the OECD GLP FAQ.

What Is ALCOA+? How Can We Use It To Improve Data Integrity And Compliance?

Posts started from:
10-Jun-2020
ALCOA+ is a mnemonic device for measuring the level of evidence provided by compliance records. It stands for Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring and Available.

Easily Look Up Terms Defined in the GLPs with the GLP Definitions Browser

Posts started from:
26-May-2020
I wanted to be able to go to one place to easily search for definitions of GLP terms, so I built a GLP definitions browser.

Oops, Did I Send that to Everyone? Validation Lessons from One Bad Morning.

Posts started from:
3-Jun-2019
An unfortunate mistake is turned into a lesson on Computerized Systems Validation.

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Join me every weekday as we take a few minutes to explore, design, test and improve the critical systems we use in our regulated facilities. From spreadsheets and software to SOPs and forms and beyond.
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About Brendan

I'm a multidisciplinary computer geek with an engineering degree, RQAP, communication skills and lab experience. I have been designing, building, fixing and automating quality systems for GLP, GMP and GPP facilities for the better part of 20 years.
In that time I've run QA departments remotely, performed and hosted many compliance inspections and audits, validated computerized systems, and even spent a few years as the
QAP
of a cannabis extraction facility responsible for safely releasing product. I've built quality systems from the ground up, and also helped companies hammer some very square off-the-shelf SOPs into the very round holes of their operations.
I've written, reviewed and fixed
hundreds
of quality systems components such as spreadsheets, SOPs, forms, specifications and validation plans. I've seen the good, the bad and the ugly, and personally felt the pain of being governed by badly designed SOPs, MBRs, forms and validation documents.
The most common reason for problems? The only real design effort that was put into these components was to make sure the regulatory / QMS compliance checkboxes were satisfied.
I consider it my mission to help regulated companies move beyond just compliance to improve data integrity, product quality and process efficiency
I believe that frontloading the effort into an intentional design of regulated processes will pay back multiples in your day-to-day operations. It's not always easy, but with the right tools and techniques it can be made simple.
Join me
on the Daily HaiQu newsletter and explore how to make incremental improvements that design quality and efficiency into your systems.
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