The FDA’s analysis of medical device recalls reveals that nearly 8% of them are attributable to software failures. Of those software related recalls, 79% were caused by software defects that were introduced when changes were made to the software after its initial production and distribution.
Our Software Validation Services for Pharmaceutical, Biotechnology and Medical Device Companies are a principal means of avoiding such defects and resultant recalls. Software validation is a requirement of the Quality System regulation, which was published in the Federal Register. Validation therefore establishes evidence that provides a high degree of assurance that a product, service, or system accomplishes its intended requirements. This often involves acceptance of fitness for purpose with end users and other product stakeholders
For medical devices, as an example, validation requirements apply 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. 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. 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 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. Such computer systems must be validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.
AMERICA ONE specializes in helping companies assure their compliance with FDA and global regulations. Our team of experienced validation professionals can assist your firm in the following areas …
- Regulatory Strategy for Pre-Market Submissions and FDA Review
- Audits & Validation of Software, Processes, Systems & Equipment
- Assistance with Audit Response 483, Warning letters, Product Recalls
- Inspection Audits & Mock Inspections
- Preparation of Quality Manuals & Procedures
- Quality Assurance Systems Development
- GMP/QSRs compliance
- F510(k)s Pre-Market Notification Submissions
- PMAs – Pre-Market Approval
- Master Planning & Risk Planning