Softek operates on a highly regulated environment and also remains in compliance with FDA, cGMP, CFR 21 and other regulatory requirements. That is why we know and understand your needs and challenges.
We are managed and audited on SOPs under the direction of a Quality Department. We develop products with a Software Development Lifecycle (SDLC) and validate all products before they enter the marketplace. In addition to pre-validated software, we also provide IQ/OQ validation protocols’ packages and validation services support.
Whether your challenge is setting up a validation or qualification program, an emergency response to a critical compliance situation, or you need resources to partner with your QA Team, our Quality Assurance Validation Services Team will respond quickly with expertise and results.
Softek provides you the highest quality integrated service, conducted in strict confidentiality.
Validation Practices and Documentation
Validation Master Plan Development
Standard Operating Procedures (SOP)
Development and Implementation
Installation, Operational, and Performance Qualification
Final Report Development