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Beyond Compliance

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Here are the latest posts:

In Defence of Laziness

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I have to admit that when it comes down to it I’m just plain lazy. So lazy that I’ll spend hours trying to save mere minutes on a repetitive workflow. Today we’re going to talk about the
Mother of Invention:

Just Pick a Date Already!

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Dealing with dates can get quite complicated: Who's doing the data entry? Are there multiple dates to enter or just one? Do they know the date before they pick it, or are they choosing a date based on some criteria? Is the date in the past or the future? What date spans are legitimate entries? Is it a leap year? Today we're going to take an example of a 3-part scrolling date picker and use it to explore a few things about form design.

The Unconstrained Text Box

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Whether on paper or online, the unconstrained text box is the most common type of form input that you’ll find in the wild. This week we’re going to look at the use of text boxes as form fields, and why a little bit of thought and effort up front can greatly improve the quality of your collected data.

The Boundary Law and its Application to Complex Systems

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There is a period of about a week or two before and after the New Year that feels different from the rest of the year... Perhaps there’s a difference in the rate of business, your social calendar, the number of “top ten of 2022” lists. Outside of that 2-week “layer” on either side of the year “boundary”, the years actually look very similar. This week 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?

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In today's 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. They look really similar on the surface. 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? Aren't we just writing files to some hard-drive or storage media either way?

Front-Load Effort Like a 1980s Video Game Developer

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Video game developers in the 1980's had to make complex, fast moving games work on computers that were less powerful than the chips that run today's toasters. This week we take a look at two of the strategies they used to reduce the amount of work that had to be done on the critical path, and learn some lessons we can apply to our processes.

Why Would You Want to Validate a Spreadsheet?

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Why would we want to validate a spreadsheet, regardless of the compliance requirements? What do we get out of the deal?

Using Constraints to Liberate - Fitting Things Together

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Using constraints to help us not only to write better scoped SOPs; but to design an intentional interface between the SOP and the wider system.

When is it OK to use 'Approximately' in an SOP?

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One of the key tenets when writing SOPs is to 'Be Precise, but not too Precise'. Basically what this means is that there's a balance to be had between having
enough detail
to meet your quality and compliance goals, but not so much detail that it makes the task too difficult, wasteful or time-consuming. Where does the word
fit into this?

Don't Write an SOP Like it's a Science Paper or a Regulation

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Don't write an SOP like it's a science paper. Don't write an SOP like it's a regulation. Not like it's a training manual, either. In what seems to have become 'SOP November', I have spent some time leaving the concept of the SOP rather open to interpretation. In this week's post, we’re going to narrow things down a bit and disavow several styles of writing that often shows up in SOPs.

Longer Articles

Here are some longer articles that I've written, and those with alot of visual content that wouldn't work in the email format. Note that some of the older ones are hosted over at my
Good Practices

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

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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?

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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

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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.

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An unfortunate mistake is turned into a lesson on Computerized Systems Validation.

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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
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
of quality systems documents such as 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 documents 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 my weekly newsletter and explore how to make incremental improvements that design quality and efficiency into your systems.
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