The GxP Practice

Built From
Inside
The Industry.

This practice was built from the ground up inside the regulated industry. Two decades across two of Africa's most recognised clinical research organisations, defending IT systems across regulatory inspections, sponsor qualification audits, and accreditation assessments. Every major authority operating on the continent. Zero findings.

Back to GxP Services
0
Zero IT-Related Findings
Across Every Inspection.

FDA, EMA, WHO, SAHPRA, SANAS, and international sponsor qualification audits. Spanning 20 years, multiple organisations, and every major regulatory framework operating in African clinical research. Not once did an IT system fail under audit.

Most IT providers learn about GxP from a course.

We learned it from the inside.

Two decades inside Africa's leading clinical research organisations. Not consulting. Not advising from the outside. Actually in the building, owning the systems, sitting across the table from regulatory inspectors, sponsor auditors, and qualification assessors across every major authority.

Every time, the systems held.

That experience is what 10-Bravo's GxP practice is built on. Our team is GCP qualified and trained in the standards that govern your environment. We don't just understand the regulation. We've defended it.

Zero findings. Every audit. No exceptions.

Qualifications & Certifications

Credentials

GCP
GCP Certified
ICH E6 Good Clinical Practice. Core certification for clinical trial IT environments, covering investigator responsibilities, data integrity, and electronic systems in clinical research.
GAMP 5
CSV Subject Matter Expert
ISPE GAMP 5 risk-based validation across the full validation lifecycle. Applied across the complete range of regulated computerised systems in clinical and laboratory environments.
GLP
OECD GLP Trained
OECD Good Laboratory Practice Series 17 & 23. Governing laboratory IT infrastructure and raw data management systems across regulated laboratory environments, including ISO 15189 medical laboratory and ISO 17025 bioanalytical laboratory accreditation environments.
ALCOA+
Data Integrity Architect
Designed and implemented ALCOA+ data governance frameworks across enterprise database environments for multi-site CRO operations. Primary SME across all regulatory inspections, sponsor qualification audits, and accreditation assessments.
DATA PRIVACY
Information Officer (POPIA)
Served as Information Officer under POPIA, responsible for data residency, subject access rights, and cross-border transfer protocols for South African and multi-jurisdiction clinical trial operations.
GDPR
Data Protection Officer
Served as Data Protection Officer for GDPR compliance across EU-interacting clinical operations. Managing data obligations across multiple jurisdictions, applicable to pan-African and international multi-site trials.
Inspection History

Regulatory Inspections
& Sponsor Audits

FDA
US Food & Drug Administration
Regulatory inspection and sponsor audit readiness. Technical defense of IT systems, electronic records, and CSV protocols at a SAHPRA-licensed Phase I CRO across multiple audit events throughout career.
EMA
European Medicines Agency
EudraLex Volume 4 Annex 11 compliance. Computerised systems, audit trail integrity, electronic signatures, and access control configuration.
WHO
World Health Organization
Defense of backup architecture, disaster recovery protocols, and electronic record-keeping systems. Served as primary SME for data integrity and audit trail defense.
SAHPRA
SA Health Products Regulatory Authority
Local GCP compliance, data privacy alignment (POPIA), and IT vendor oversight for South African and multi-country clinical trial sites.
SPONSORS
International Pharmaceutical Sponsor Qualification Audits
Technical GxP IT qualification audits conducted by global pharmaceutical sponsors across EMEA. Covering vendor qualification, data integrity, CSV documentation, and infrastructure state-of-control assessments. Too numerous to enumerate individually.
SANAS
South African National Accreditation System
IT infrastructure and systems defense during ISO 15189 and ISO 17025 accreditation assessments for clinical and bioanalytical laboratory environments at a Phase I CRO.

Ready for an IT partner
who understands your world?

Whether you need day-to-day managed IT support, audit preparation, system validation, or all three. Book a conversation and we'll walk you through exactly how we work in your environment. No jargon. Just straight answers.

Book a Meeting
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