Types of Software Requiring Validation The word Validation is not new but those who are now associated with manufacture of Medical device must learn about this part. Instead of learning jargon of validation let us understand what software validation means. The terminology is same for equipment, system or process and software is also process of coded language which governs some process. Validation is to prove that it does those steps of processes in the same way it is designed and performs that part repetitively in the same manner. This needs to be proved by doing some process performance work and noting result and keeping them as record as proof of validation in the form of validation report. E.g. In Electronic BP Machine which measures the Blood pressure. Pulse and records results of previous measurements. Traditional mercury BP instruments also works on same principal but it requires some skill to measure so only trained medical professional can do that while electronic measurement is done by anyone only instruction is to place loop belt at proper place. So, this software needs validation. This is now one component of device. Many Companies doing computer system validation frequently ask us whether software validation is mandatory for their exact software or systems. And they often insist that they must validate their whole system as expert in the field. While that suggestion maylook logical, it is not always true. If you do that extra which is not required nobody will question but it costs lot of money and other resource and that is the reasonwe must know what kinds of systems need validation. 1. Medical Device Software Medical Device software is well-defined as any software that is used as a component, part, or accessory of a medical device, and software that is itself a medical device. (As described above in BP measurement device) Examples
Diagnosis of disease (i.e., medical imaging software, arrhythmia detection software)
Cure, mitigation, treatment, or treatment of disease (i.e., laser software, hospital bed software)
Prevention of disease.
2. Production Software Production software is software as well as systems used in the making of medical device. FDA regulated devices needs validation here too because it expects that your process should produce the device of same performance value defined in the range. Variation in software can give different results in product. This category contains:
Software that controls manufacturing equipment (i.e., PLCs, CNCs, inspection software)
Software that manages the manufacturing process (i.e., factory automation, production monitoring, bill of materials)
Laboratory testing software. Though they are not attached to process or medical device, but they are the one which can prove the authenticity of testing.
3. Quality Management Software Quality Management software as well as systems are those used in programs planned to confirm quality products. If software do not control process well lot of harm can happen to user through delayed or no response to complaint. Management of returns and recourse action. The FDA has issued Warning Letters. Fewexamplesare below:
Product returns or recall management software
Complaints software
Change control software
4. Software for FDA-Regulated Records Software for FDA-regulated accounts is well-defined as software used to form, modify, maintain, archive, regain, or convey FDA-required records. And electronic records presented, per the FDA. FDA-regulated accounts software examples contain:
IRB records software
Adverse Event reporting software
Organ/Tissue Donor records
Now that you see the kinds of software that require validation, you can detect whether your software wants to be validated. moreover, you can apply the regulatory expectations for software validation to decrease the amount of efforts on your later validation project. There may be another question whether off the shelf software require validation like above. Answer is yes, if your risk assessment say high risk and you do not have any data from manufacturer. Answer is no or only some part validation where you use limited functionality so get that information from vendor or only do partial validation of your requirement. All said look simply but are complex and expert help is must to make job easy and perfect, acceptable to regulatory and easy to understand. IZiel is one such company who guides many reputed devices manufacturing company can be good choice.