In pharmaceutical and medical device industry many manufacturing process depend on computer software( Also see 21 cfr part 11) in early times there were many cases found, where the medical deices were recalled just because of software malfunction, later it was found that those faults were caused due to improper implementation of changes made in them, lack of change control impacted the production of faulty medical devices.
Therefore now software validation is a requirement of the Quality System regulation, which was published in the Federal Register on October 7, 1996 and took effect on June 1, 1997. (See Title 21 Code of Federal Regulations (CFR) Part 820, and 61 Federal Register (FR) 52602, respectively.) Validation requirements apply to software used as components in medical devices, to software that is itself a medical device, and to software used in production of the device or in implementation of the device manufacturer’s quality system.
Software validation definition as a process which confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.”
Unless specifically exempted in a classification regulation, any medical device software product
developed after June 1, 1997, regardless of its device class, is subject to applicable design control
provisions. (See of 21 CFR §820.30.) This requirement includes the completion of current
development projects, all new development projects, and all changes made to existing medical device software. Specific requirements for validation of device software are found in 21 CFR §820.30(g). Other design controls, such as planning, input, verification, and reviews, are required for medical device software. (See 21 CFR §820.30.) The corresponding documented results from these activities can provide additional support for a conclusion that medical device software is validated.
Any software used to automate any part of the device production process or any part of the quality system must be validated for its intended use, as required by 21 CFR §820.70(i). This requirement applies to any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, complaint handling, or to automate any other aspect of the quality system.
In addition, computer systems used to create, modify, and maintain electronic records
and to manage electronic signatures are also subject to the validation requirements.
(See 21 CFR 11.10 (a).) Such computer systems must be validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.
Software for the above applications may be developed in-house or under contract. However, software is frequently purchased off-the-shelf for a particular intended use. All production and/or quality system software, even if purchased off-the-shelf, should have documented requirements that fully define its intended use, and information against which testing results and other evidence can be compared, to show that the software is validated for its intended use.
The use of off-the-shelf software in automated medical devices and in automated manufacturing and quality system operations is increasing. Off-the-shelf software may have many capabilities, only a few of which are needed by the device manufacturer. Device manufacturers are responsible for the adequacy of the software used in their devices, and used to produce devices. When device manufacturers purchase “off-the-shelf” software, they must ensure that it will perform as intended in their chosen application. For off-the-shelf software used in manufacturing or in the quality assurance system.
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21 CFR Part 11 Requirements
Medical Device 510(k) Clearances