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The Daily HaiQu

I'm Brendan Hyland. I help regulated facilities transform their software, spreadsheets, workflows and documents from time-consuming, deviation-invoking, regulatory burdens, to the competitive advantage they were meant to be. Join me every week as we take a few minutes to explore, design, test and improve the critical systems we use in our facilities.

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What are some of the hazards of using a data processing spreadsheet?

Let’s say you want to develop a spreadsheet that’s used over and over again to process batches of data. What are the some of the hazards to data integrity associated with using such a spreadsheet? It might have bugs in it at the time of release. Its functionality might change unintentionally during use. Someone could use it incorrectly. Someone could enter incorrect data. Someone could accidentally change data that’s already been entered. The software or computer could crash during data entry...

Last time we left off with a cliff-hanger of a question: How do you prove you're you when signing a document? There are several ways I've seen that the 3rd party providers prove that it's you who's signed the document: You clicked a link from an email. You paid for the service with a credit card. You provided some government issued photo ID. Someone, such as a notorized public or your HR department, has verified it's you in person. Obviously these are very different levels of assurance. Then...

There are several levels of 'signatures' that you can apply to an electronic document. The first and most basic is just an image of your written signature. One common option for this is to print the document, sign and scan it back in again. A more convenient version is to have an image of your signature saved that you can paste into documents. This is what many free versions of pdf software and word processors offer as a basic document signing option - a 'stamp' of your saved signature image....

Ever since COVID, document and signing workflows have been incorporated into everything. Dropbox has it. Microsoft Teams has it. Google Workspaces has it. If you need e-signatures, you probably have access to Docusign, Adobe, Hellosign, and so on. But what exactly are we talking about when we say "document and signing workflow"? Let's step back. Most document workflows are about moving some work through review, commentary, revision and approval. The old way to do this was to send a document...

Hazard Name: The Wayward Cell Block The Wayward Cell Block can often be detected by the green warning triangles, or a #REF! error at the edges Description: An unintentional change in a block of formulas caused by accidental cut-n-paste, drag-n-drop, fill handle functions, or flash fill. Often results in a similar looking formula, but with the cell references being offset by one or more rows or columns. Detection: When resulting in an inconsistent formula in a row or block, these are usually...

Electronic signatures are not a 1-1 replacement for every place you might use a paper signature or initial. This has implications when you’re taking a previously paper-based process and going digital - to try to convert the SOP step-for-step and record-for-record into the digital medium would be to lose some of the benefits of a digital workflow. Let’s say you’re moving a document review and approval workflow to a digital system. If you’ve chosen your software carefully based on pre-written...

In paper systems we use the “dated signature” or “dated initials” to do so many things: Identify people Identify when something happened Signify that a step was completed Establish the order in which things were completed Ensure the correct person completed a step Prove that a document was reviewed by appropriate roles Approve or otherwise attest to something about a document …and so on. Basically the limitations of paper mean that anytime we want to distinguish a record from any random...

There are many ways you can get data into a spreadsheet. You can type it in. You can copy and paste it in from another digital file. You can use a macro or some VBA to automatically pull it in from somewhere. You can use some of Excel's built-in features to 'connect' to an external source like a database. You could even dictate it in, cell by cell. Each of these input cases has its own hazards. Typing can be subject to typos. Copied data can be pasted into the wrong cells, or be the wrong...

Now, opinions differ on this, but my obviously correct one is that QC should be a separate process from QA. That is to say, that someone (e.g. part of the study or operations, or in a separate QC capacity) should be checking over the correctness of any datasets. For example, doing a comparison of any copied or transcribed data against the original source. Checking all values in report tables against sources. Checking values in report text. Checking units, formats, spelling, grammar, etc. etc....

Once I've got the basic idea of what I'm looking at and how it's been populated and controlled, it's time to look a the data. The first thing that I do is a scan of the data. For smaller tables I'll zoom out and take a full view of the whole. For a large, table-shaped dataset like you find in many spreadsheets, I'll start with a Z-shaped scan of the data: across the columns in the top few rows of data, diagonally down to the bottom few rows, and then back across again. This allows your eye to...

When you're confronted with a spreadsheet full of data, how do you audit it? where do you start? What kind of things should you be looking for? Let's say I'm seeing a data processing spreadsheet template for the first time. Before I even open up the spreadsheet, I want to ask a few questions: What exactly am I looking at? Is it the spreadsheet file itself, or a printouts / PDF images of the spreadsheet? If it's an image, is it the complete record? What's the use case for this spreadsheet?...