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SOFTWARE

QUALITY

Empower Your Medical Device Software for Success with Our Expert Quality Assurance Services and Collaborative Approach.

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MEDICAL DEVICE 

VALIDATION IEC62304

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.

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COMPUTER SYSTEM 

 VALIDATION (CSV)

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.

SERVICES

OUR

 We work with you across all components of Software Quality from creation to day-day administration.

Data Integrity

Assessing risk to data integrity and making recommendations to ensure data accuracy and consistency across a system's lifecycle.

Risk Management

Assessing system risks and providing recommendations for a risk-based approach to validation activities.

Software V&V

Providing support with validation lifecycle activities to prove that your system works in its intended environment​.

Gap Analysis

Conducting  gap analyses of your systems against regulatory requirements, with recommendations on how to address gaps.

CLOUD VALIDATION
(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.

Lifecycle Documentation

We work with you to author validation documents. From Defining requirements, To providing templates, quality reviewing and remediation.

Configuration Management

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.

Spreadsheet Validation

Verifying the reliability of your spreadsheet and its output for its intended use.

CHAT

LET's

Need Support?

Drop us an email and let's connect for a virtual coffee.

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