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Advanced Quality Management Support for Your Success

DIGITAL MANAGEMENT

e-QMS SUPPORT

With a deep understanding of diverse e-QMS environments, we tailor our services to meet your specific needs and platform,  providing comprehensive support that covers implementation, optimization, compliance, and ongoing management.

 

Our goal is to streamline your quality processes, making them more efficient and compliant with regulatory standards, while also being flexible enough to adapt to the ever-evolving landscape of our industry.

SUPPORT

OUR

Supporting your DIGITAL e-QMS systems..

DATA INTEGRITY

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

e-QMS MANAGEMENT

Supporting your Quality Management Teams in the day-day operations and management of your EQMS. 

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.

WORKFLOW MANAGEMENT

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 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

Streamline Your Quality Management with Expertise You Can Trust.

 

Email Us Today for Tailored e-QMS Support That Sets You Apart

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