I was recently hired by a company in the pharma industry that is formulating a product that will be sent to a cGMP lab to produce for use in a phase II. I am new to the industry so bear with me.
I was told to work on validating COT software such as Word and Excel. There is conflict in the workplace about whether or not this is necessary as we are not GMP.
Does anyone have an opinion on this?
Validating MS Word? Seriously? For what?
You can’t validate Word or Excel for that matter. You CAN validate your use of them (although I can’t see any rational approach for validating your use of MS Word). A quick internet search of “Excel Validation” will yield plenty of results. Bear in mind that you are validating it for your intended use. Not the general case. For such validation, you’ll want to consider macros / formulas used (and data used as input), security (locking cells, etc.), and what happens to the sheets after initial entry. You HAVE to wrap a process around use of Excel to have a defensible validation position.
If your outputs are inputs to a GMP facility, I would expect such requirements. Pedigree of your product needs to be established.
It is not necessary to validate commercially off the shelf software, like MS Word for generating word documents or Excel for spreadsheets, for their general purpose. However, if you are using the MS Excel to calculate results for example, you will need to validate the spreadsheet developed, to have a high degree of assurance that the macros or formula within works. Bespoke software pertaining requires validation since it would be something new and has not been qualified before. Extent of validation will depends on the level of customization of the software.
If your product is for GMP purpose, the systems that support the manufacture or formulation of this product would need to meet GMP requirements.
can only agree with yodon and nateekgnel
Also I do not take your statement for granted that your company is not under GMP regulations.
Whenever you produce for a product that will go to patients or clinical trials, you are subject to the regulations. Your customer company is obliged to make sure that you are working according to GMP standards.
If you can have a look in the contract. If there are no clauses on GMP standards, I would be very suprised. Or check with your QA.