In the pharmaceutical industry and the medical sector, given the critical nature of the operating environment, the health of the people involved in the process (patient and/or technical team) requires a very high level of quality for products that are developed in this area. This level of quality aims to analyze the risks of the system and verify that these risks are identified and solved as far as possible, and the risk degree must also be defined that the system leaves when ends its development, in order to measure the suitability of the solution provided. We must take into account the risks and the ways to mitigate them. We use high-quality regulations such as Good Manufacturing Practices (GMP) or Food and Drug Administration (FDA) and compliance is verified and validated of the same through an exhaustive process of verification and validation.
At SQS, we offer independent verification and validation services to safety critical systems and in which the adaptation of regulatory development processes related to the software system are necessary.
To achieve and guarantee the quality required by the current standards and regulations in the pharmaceutical industry, SQS offers a complete service to our clients to incorporate software quality activities such as:
- Designing and implementing testing environments.
- Coordinating test processes. Defining test tasks.
- Formal documentation reviews.
- Code reviews.
- Integration and unitary tests.
- Acceptance and functional tests.
- Dynamic and static methods.
- Risk system analysis
- Implementing Security and Quality Standards.
- Training customer’s staff.
