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​.
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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.