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Comprehensive consulting for software verification and validation and software quality assurance in the medical device and the bio-pharmaceutical fields.

Computer and software validation standards at pharmaceutical, biotech and medical devices companies are under intense scrutiny by the FDA, CE and other regulatory bodies. As the regulators gain a deeper understanding of the safety risks involved in software development, they are continuously re-evaluating the computer and software validation standards. Knowing what needs to be validated and deciding how much validation is enough is a critical and challenging task for developers and manufacturers. As FDA, CE and other regulatory inspections become more stringent, it is essential that the changing guidelines and requirements are clearly understood and followed.

The basis of SoftQuest Systems validation is to provide documented evidence that the software developed has been verified and validated to ensure that they fulfill all regulatory expectations. Our approach to validation is pragmatic and emphasizes the significant value added.

We are very familiar with the industry standards and strive to satisfy all the regulatory requirements.

Experience

We have over 20 years of experience in the medical device industry providing software validation and quality assurance services.

Compliances

Our work complies with the IEC 62304 and the FDA guidelines for software life cycle development.

Software Quality Policy

We have a Software Development Life Cycle (SDLC) Procedure complying with IEC 62304 and a Computer Software Validation Procedure complying with ISO 13485:2016.

Verification and Validation (V&V)

We provide services in writing software requirements, design and performing software validation.

Software Quality Assurance (SQA)

We provide SQA monitoring to assure compliance with the company’s SDLC procedure.

21 CFR Part 11

We provide services in assessing software products for compliance with 21 CFR Part 11.

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