Validating Calibration Management Software for 21 CFR Part 11 is a pain, but with the right mind set the process can be speedy and beneficial. Given some trade tips and good advice there is an easier way to plan, construct and execute a validated compliant management software for the pharmaceutical and medical world of metrology.
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The whole process of purchasing a software package, figuring out the auditing logs, purchasing a validation protocol purchasing training on the protocol, hiring help and filling out the 500 ? 1,000 page document for 21 CFR Part 11 compliance is as tedious as it is mind-numbing. On the fun things to do list working on validating software for 21 CFR Part 11 falls somewhere between getting a root canal and walking on broken glass. All that said, as with any other torturous activity, validating software can be made easier and relief can be found given some tips.
Choose the Right Calibration Management Software
If the software being validated has already been purchased then ignore these next paragraphs and move on, otherwise read on.
The task of finding the best fit software for any given company is a whole dissertation in itself. see the article entitled Software, Software, Everywhere Software, published in Callab Magazine, by Brad Price, President, One Red X Software, Inc. for a detailed process for finding the best software. The importance of finding acceptable, robust and stable calibration management software cannot be stressed enough. Too often companies rush into a software choice that will most likely be replaced in a couple years because of new technology or bad design.
Briefly, here are the main points from ?Software, Software, Everywhere Software? for choosing calibration management software:
Evaluate the environment that the software will be run on and make sure that you have the hardware available for the software.
Before seeking a software package sit down and develop a simple work process flow chart of your facility, starting from the time you contact the customer through the time you return the equipment to the customer.
The next step is to determine what operating system and style platform you want to run on.
Lastly, ask the right questions. Find out everything you can about the software company, references and what features the software offers. Is the software flexible for the long run and will technical support be available when needed? Ask the questions and record them to decide which software vendor is going to satisfy the needs of the company best.
Understand the Software
Before beginning the validation, it is prudent to actually know the software, so you will be able to speak intelligently with the vendor and coworkers optimizing the validation procedure. The 21 CFR Part 11 compliant software should have an auditing log and electronic signature function that would be important to find and understand well. Some basic understanding of the software will help immensely especially since the software has to be validated by the customer themselves. When the validation protocol is being executed, this basic understanding comes in handy as the user moves through the software validating functionality. The point is: time will be saved no matter how you look at, if you simply experiment with the software or have some basic knowledge of how the software works before going through the validating long haul.
Setting up the Environment
Before starting the validation process verify that the business practices for the software are in place and all the customizations have been completed for the software. Software packages usually have a lot of settings, customizations, workflow processes and reports that are set-up specific to a companies requirements. Make sure everything is customized correctly and ready for use before validating the software, this decreases the chance of returning to patch up things that change later. Talk with the vendor, validation experts and anybody else that may have experience preparing for a validation for that software.
Schedule the Completion
Create a deadline for the validation to be completed. Ask the software company how long approximately it takes to complete the validation document and schedule accordingly. Find out if the document can be completed by more than one person and if so the work of executing scripts may be split up between two or three persons. Have a validation expert review the document often to verify that the proper steps are being taken to make sure the document is being completed right the first time.
Begin using the Document
Start at the beginning of the document. This may seem obvious, but it is important to complete whatever prerequisites that the document specifies first before continuing in the document. The prerequisites often require that the system requirements are met and the environment is set-up correctly.
The document should be straight forward and easy to use. So if something seems not quite right, something probably needs to be adjusted and calling the software vendor or validation expert is suggested.
Here are some general rules as one goes through the validation process:
Consider the option of testing the software on a copy of the software?s database, thus eliminating the chance of damaging real data or adding a slew of play data from the testing.
If something seems hard or confusing, stop and call the vendor or have a validation expert review the document.
For customized systems, the scripts in the document may not read exactly the same as it is in the software itself. Amendments may need to be made to the document to match these software customizations. So, if something can?t be found or is drastically different in the document verify you have the right document version for the software and that the software hasn?t been customized differently from the COTS (commercial off the shelf) system.
If the software has a backup option, backup often! Who knows what kind of mess will be caused as the software is tested for all sorts of angles, that way you always have a stopping point to return to.
The validation process is not fun but maintaining consistency in completing it and staying in contact with the software vendor and validation experts will ensure a speedy validation. Good Luck!