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Custom Versus Configurable Software Tools – do you know the difference?
I have had many conversations with individuals related to the many software tools currently available on the market these days. Inevitably, the discussion turns to the need to “customize” the tool for specific use, and the need for validation.
Customized software tools require the manufacturer or the customer to modify the source code of the product to meet a specific intended use. The software or product is designed to be specific to the needs of the individual customer.
Configurable software tools are tools designed to allow the customer to select certain functions or combinations of functions without modifying the source or base code. The options have already been designed into the software tool. The user just needs to turn on the “switches” or choices to have the tool work a specific way to support your business.
It is very important to make the distinction between custom as configurable in order to support a successful validation and implementation.
Most of the tools on the market today have many combinations of functionality built into the design. The manufacturer is responsible to validate the various functions and combinations for the entire software package. This is often referred to as “white box” validation. The customer functionality is implemented by selecting various functions and/or operations in a combination to meet specific customer needs. The customer is then responsible to validate the configuration for intended use, otherwise known as “black box” validation. Since source code isn’t being modified, the validation becomes less intensive. Of course, you should request some system validation certification and/or documentation from the supplier of the software tool validation.
True customization requires modification to the actual source code of the software. This requires a much more intensive project, since you are actually modifying the product. Design requirements, software coding, verification, validation and risk management all need to be reviewed and documented to support changes. This becomes very time and resource intensive, and can be very expensive to support. Once the source code is customized for a specific customer, all modifications for future upgrades can become a major project. Once the product is customized, it is no longer considered an off-the-shelf product. Any routine modifications and upgrades will probably not be available, unless you want to purchase additional customization.
Bottom line:
· Understand the process you want to automate prior to purchasing a software tool.
· Challenge your software vendor during the selection process to ensure the system you select can be configured to meet your process needs without impacting source code.
· Confirm how interfaces are handled when connecting to other tools, such as ERP systems. There may be some scripts or coding required for the interfaces, but the hooks or connections for interfaces should already be built into the software.
About the Author
B. Christine Park is a quality systems consultant with expertise in the implementation and remediation of sustainable and regulatory compliant quality systems. She has led the successful implementation of quality systems in large corporations, as well as small startup companies. Her industry experience and background supports compliant yet practical, pragmatic quality systems. She can be contacted at 678-480-5411 and cpark928@mindspring.com
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Comment
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Comment by B Christine Park on August 18, 2011 at 9:37am -
Ken Thank you for the comment. I have not reviewed the most recent GAMP5 document with the category classifications. I did some research and found a white paper from Master Control on GAMP5 www.mastercontrol.com. The whitepaper is free and might be helpful. This document identifies category 3 as non-configurable, category 4 as configurable and category 5 as customizable. I don't have access to the definitions but would interpret category 3 as a straight "off the shelf" use as is. No configuration or customization allowed. If that is a fair definition then you would still have to validate your use of this software in your organization. The flexibility of the tool would be greatly reduced. I would also anticipate greater change within your own quality system as you would potentially have to modify your processes and/or procedures to meet the capabilities of the software tool. Again this is supposition since I haven't read the GAMP5. I welcome anyone else to comment.
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Comment by Ken Appel on August 17, 2011 at 11:28am
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Your description of custom is very clear (defined in GAMP5 as category 5 software). My question is about whether to designate software a category 3 or 4. The distinction carries the weight of resources needed from both supplier and end user to support the software (URS, FDA, testing, etc.). My understanding is that category 3 software allows the user to make selections (configuration) the application from predefined choices and category 4 software provides the ability for user programming (or configuration) of the application, a PLC, for example. I believe it comes down to whether changes can affect CQAs. However, this could be the case in both categories. Could you comment?
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