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Validation Services

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Validation

Services

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 validate products before they enter the marketplace

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.

We respond quickly with expertise and results

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.

We keep strict confidentiality

Softek provides you the highest quality integrated service, conducted in strict confidentiality.

Services Include

Validation Consulting

Validation Practices and Documentation

Validation Master Plan Development

Design Qualification

Standard Operating Procedures (SOP)

Development and Implementation

Installation, Operational, and Performance Qualification

Project Management

Protocol Execution

Final Report Development

Vendor Audits

Want more information? Download our Products Brochure

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