During the course of software engineering, testing and software project management, validation refers to the process of verifying that a software solution meets required specifications. This is a formalized process and is required within the life sciences. Software validation will ensure that your software solutions comply with requirements. Failing to do so can result in your company being issued a 483. If a computer system is used to provide information to a regulatory body (such as under FDA 21 CFR Part 11), or meet requirements for the regulatory body, the system must be validated.
Software Verification: This initial stage provides evidence that the software meets its design outputs. Verification checks for completeness, correctness and consistency within the software and within its supporting documentation are performed.
Software Validation Services
A software validation service should be able to validate not only your software, but also your computer systems and databases as well as the development of appropriate documentation. A Validation methodology should be of an impeccable standard and should complete the projects in a reasonable time for a cost-effective price.
Ultimately, the aim of a good software validation service is to improve the compliance, value and quality of your integrated computer system. All validation protocols should be executed in a timely manner and all documents should be detailed and complete.
If you have any questions about software validation services, contact our experts at Innovatum today, so we can address your questions and concerns. Our team has more than 20 years of experience with validation services for the compliance challenges of life sciences industries.
