Good day Sara,
There are a few ways to handle static versus dynamic files, though I would say this would be mostly aligned to your document control system (electronic systems) and how this is established/implemented. As an example, a typical static versus dynamic record I often encounter is a Approved Supplier List (ASL). There is a procedure defining the process and how the form is completed and there is probably a "released" form which is the ASL. A template form (which can also be a database) containing a supplier number, supplier name, contact info, qualification date, risk-level of supplier, etc. are part of the template. Let's say the ASL template is Form 123 Revision A (which can also be the structure of the database or spreadsheet). So the only time Form 123 is revised is say a column is added or deleted - the structure of the form (static). But now this form needs to be filled in with all of the supplier information. So how does this now dynamic file/record get controlled. Do you revise it each time a new supplier is added or one deleted? Is there a date control? Or does it just get updated? Often the ASL is assigned a document number to track in the system and then revision level can be different methods. So in answer to your question there are dynamic files or I would more refer to as a dynamic record can be modified, updated, calculated, automatically calculated over time, etc. It really depends on the electronic system, document control practices, and procedure which would define how dynamic files/records are maintained. Static files I believe are quite straight forward in a document control system.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 28-Jan-2022 15:29
From: Victor Mencarelli
Subject: Static vs Dynamic Files
Hi Sara.
I typically think of this pragmatically - if the file can be changed it is dynamic. So in general I would consider things like locked pdf's, password protected files, etc. to be static. Pretty much anything else is something I would consider dynamic.
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Victor Mencarelli
Global Director Regulatory Affairs
MelvilleNY
United States
Original Message:
Sent: 28-Jan-2022 08:47
From: Sara Guyler
Subject: Static vs Dynamic Files
Does anyone have guidance they can share on what is considered a static vs dynamic file? For example, would a fillable form uploaded into an electronic regulatory system be considered dynamic because it can be changed, or is the industry standard for dynamic files more focused around built in logic/automatic calculations?
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Sara Guyler
Global Regulatory Specialist
United States
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