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Beyond Compliance

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Here are the latest posts:

Breaking down the design of our interface.

selective focus photography of mixing console
Posted on:
21-Nov-2023
Let's take another look at the interface for example 1 in terms of the 'shape' and 'type' of the data coming in and out of our system.

Food for thought

shallow focus photography of almonds in white ceramic bowl
Posted on:
18-Nov-2023
On interfaces, encapsulated code and their relationship to requirements and testing...

Encapsulating components in Excel. Example 1: worksheet as a form

black click pen on white paper
Posted on:
17-Nov-2023
The first example we’re going to look at is to basically create a ‘form’ out of a worksheet, where the only interactions the user can make with the worksheet are the ones we’ve allowed. We'll also expose a convenient interface for developing the rest of the spreadsheet too.

Encapsulating functionality behind a well-defined interface

text
Posted on:
16-Nov-2023
Most traditional programming languages provide several ways to abstract away complexities of code, and instead present a well defined interface. What does that mean? Well, in simple terms it’s a restricted set of entry points into that code that make it clear how you can interact with it.

How do you separate concerns in a spreadsheet?

blue red yellow and green lego blocks
Posted on:
15-Nov-2023
This week we’re looking for ways we can split a spreadsheet’s data and functionality into parts that are each responsible for one thing - whether it’s to perform a calculation, hold reference data, or take input or whatever. But this isn’t computer code in the traditional sense, so how can you do this kind of separation in a spreadsheet?

The principal of separation of concerns.

person holding black corded device
Posted on:
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. This week we're going to explore this concept in relation to building spreadsheets for critical data analysis tasks.

Assigning names within a formula with the let function.

a red robot figurine with a microphone on it's head
Posted on:
11-Nov-2023
It’s Friday night, and I’m going to indulge myself with some gushing over Excel’s relatively new let function. I promise it is related to data integrity. Somewhat.

That which we call Sheet1!$A$2:$AC$43: by any other name would smell as sweet?

pink rose in close up photography
Posted on:
10-Nov-2023
Naming things in code is critically important because it’s your primary method of communicating intent to the readers of the code. Most programming languages give you multiple opportunities to name things in ways that make the code feel natural - from functions and procedures to classes and modules. And spreadsheets are no different.

Example: Using self-documenting Excel formulas for fun and for profit.

closeup photography of gold-colored ornament
Posted on:
9-Nov-2023
Excel formulas can be a mess of ranges that mean little without carefully tracing back the context. The simple act of naming things can drastically improves how easy it is to read and verify formulas. Today's example: Using self-documenting Excel formulas for fun and for profit.

When is it worth building a spreadsheet template?

rainbow frequency
Posted on:
7-Nov-2023
Let's say you had some data that had to be calculated and reported the same way every month for the foreseeable future. Would you build a new spreadsheet from scratch every month? Of course not, that would be a waste of effort, right?

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
blog.

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

Posted on:
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?

Posted on:
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

Posted on:
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.

Posted on:
3-Jun-2019
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
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 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
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