Beyond software,
value for your processes.
The expert team behind QMex supports your quality processes with consulting, validation, audit and training, run in line with the regulations.
Computerized System Validation
End-to-end validation services so your computerized systems are compliant, reliable and verified. Aligned with ISPE GAMP 5, EU GMP Annex 11 and FDA 21 CFR Part 11, we plan, execute and document validation with a risk-based approach. We provide professional support across the whole cycle, validation plans, risk assessments, test scenarios, test execution and validation reporting.
Quality Consulting
Consulting for organizations in human medicines, animal health, medical devices, cosmetics and food supplements, across GMP, GDP and wider GxP requirements. We develop solutions tailored to each organization's needs: assessing and improving regulatory compliance, Data Integrity, quality risk management (ICH Q9), process analysis and preparation for authority inspections.
Audit Services
Internal, supplier and third-party audit services that measure how effective your quality system really is. We support organizations through planning, execution, reporting and improvement follow-up, grounded in national and international quality standards.
Training Services
Training programs tailored to each organization, designed to raise quality awareness and strengthen compliance with current regulations. We deliver theoretical and hands-on courses covering GMP, GDP, GxP, Data Integrity, Computerized System Validation, quality risk management and current regulations.
Quality Documentation
Professional support for preparing, reviewing and updating the documents used in your quality processes. We help keep SOPs, procedures, instructions, forms, validation documents and other quality records compliant, reviewed and current.
HCL Notes Domino Services
Technical consulting, administration and support that keep HCL Notes & Domino environments secure, performant and sustainable. We provide need-specific solutions for system administration, version upgrades, licence management, application development and user support.
Frequently asked questions
Which services does BTS provide?
Computerised system validation, quality consultancy, audit services, training services, quality documentation and HCL Notes Domino services.
What does computerised system validation cover?
It covers preparing validation plans, risk assessments, test scenarios, executing tests and producing validation reports. The work follows a risk-based approach aligned with ISPE GAMP 5, EU GMP Annex 11 and FDA 21 CFR Part 11 requirements.
Can services be taken without using QMex?
Yes. Consultancy, validation, audit, training and documentation services can be provided independently of QMex usage.
What do the trainings cover?
Theoretical and applied trainings are offered, primarily on GMP, GDP, GxP, data integrity, computerised system validation, quality risk management and current regulations.