Empower Your Medical Device Software for Success with Our Expert Quality Assurance Services and Collaborative Approach.
Our team provides seamless solutions to bring your innovative ideas to life with confidence in meeting IEC 62304 standards..
Partner with us for success in the medical device industry.
With a focus on ensuring that your systems operate as intended and meet regulatory requirements, we'll help you navigate the complex world of GxP validation.
We work with you across all components of Software Quality from creation to day-day administration.
Assessing risk to data integrity and making recommendations to ensure data accuracy and consistency across a system's lifecycle.
Assessing system risks and providing recommendations for a risk-based approach to validation activities.
Providing support with validation lifecycle activities to prove that your system works in its intended environment.
Conducting gap analyses of your systems against regulatory requirements, with recommendations on how to address gaps.
(IaaS, PaaS, SaaS)
Validation Support of cloud-based systems, ensuring compliance to International regulations.
21 CFR Part 11 Compliance
Provide guidance in ensuring your electronic records and signatures are considered to be trustworthy and equivalent to paper records.
We work with you to author validation documents. From Defining requirements, To providing templates, quality reviewing and remediation.
Working with you to Define strategies for handling changes systematically so that a system maintains its integrity over time.
SOFTWARE SUPPLIER AUDITS
Carrying out audits on vendors of software and systems and providing documentation to support your validation strategy and demonstrate regulatory compliance.
Validation Strategy & Management
Supporting you in the development of compliant approach's to your computer system validation.
Verifying the reliability of your spreadsheet and its output for its intended use.