21 CFR Part 11 EU Annex 11 ICH E6(R3) GAMP 5 OECD GLP SAHPRA Data Privacy
Regulated Industry IT Services

IT Built for Compliance. By Design.

GxP-aligned IT for clinical research, pharma, and regulated labs across Africa. Day-to-day IT management and long-term compliance posture, delivered by someone who has sat across the table from regulatory inspectors, sponsor auditors, and qualification assessors across every major authority. Zero findings every time.

Certified & Qualified
GCP
GCP Certified
ICH E6 Good Clinical Practice
GLP
OECD GLP Trained
Series 17 & 23
CSV
GAMP 5 Validation SME
Full Validation Lifecycle
DI
ALCOA+ Data Integrity
Architect & Primary SME
20
20 Years Regulated IT
Tier-1 CRO Experience
What is GxP?
Good Practice (GxP) regulations govern IT systems, data, and infrastructure in life sciences. Clinical trials (GCP), laboratories (GLP), and pharmaceutical manufacturing (GMP). Non-compliance risks regulatory rejection, data integrity failures, and in clinical settings, patient safety. Your IT partner needs to understand the stakes.
FDA
FDA
U.S. Food & Drug Administration
EMA
European Medicines Agency
WHO
World Health Organization
ZA
SAHPRA
SA Health Products Regulatory Authority
MHRA
Medicines & Healthcare Regulatory Agency
ICH GCP
Good Clinical Practice. ICH E6
V
ISPE GAMP 5
Computer System Validation
GL
OECD GLP
Good Laboratory Practice. Series 17 & 23
§
FDA 21 CFR Part 11
Electronic Records & Signatures
11
EudraLex Annex 11
Computerised Systems. EU GxP
FDA
FDA
U.S. Food & Drug Administration
EMA
European Medicines Agency
WHO
World Health Organization
ZA
SAHPRA
SA Health Products Regulatory Authority
MHRA
Medicines & Healthcare Regulatory Agency
ICH GCP
Good Clinical Practice. ICH E6
V
ISPE GAMP 5
Computer System Validation
GL
OECD GLP
Good Laboratory Practice. Series 17 & 23
§
FDA 21 CFR Part 11
Electronic Records & Signatures
11
EudraLex Annex 11
Computerised Systems. EU GxP

GxP IT Services

From daily managed IT support to infrastructure design, computer system validation, and full audit readiness. Everything your regulated environment needs. Under one engagement.

01
GxP Infrastructure Design & Management
Audit-ready architecture from day one, maintained through ongoing managed support. Physical controls, access management, network segregation, and change control built to survive audit. Not survive until audit.
02
Computer System Validation (CSV)
GAMP 5 risk-based validation for regulated computerised systems across the full clinical and laboratory environment. Complete validation lifecycle documentation authored and executed in-house, not outsourced.
03
21 CFR Part 11 & EU Annex 11
Gap assessments, remediation, and ongoing configuration management for electronic records and e-signatures compliance under FDA and EMA frameworks.
04
IT Audit Readiness & Gap Assessments
Pre-audit assessment of your IT environment against GCP, GLP, and GMP standards. We find the gaps, close them before the auditor does, and stay in your corner after.
05
Data Integrity & Backup Compliance
ALCOA+ data governance, immutable backup architecture, and disaster recovery tested to GxP standards. So your data chain of custody holds up under scrutiny.
06
GxP IT Policy & Governance
Complete IT policy libraries aligned to ISO 27001 governance and GxP requirements. Change control, data classification, access management, and incident response. Technically underpinned by CIS Controls. Implemented, not just delivered.

We've been
in the room.

Inspection readiness is a posture, not a checklist. We've sat across the table from these authorities and defended the systems we built. Every time, the result was the same.

0
Zero IT-Related Findings
Across all regulatory inspections, sponsor audits, and site qualification assessments supported
FDA
US Food & Drug Administration
Regulatory inspection and sponsor audit readiness. IT and CSV technical defense at a SAHPRA-licensed Phase I CRO
EMA
European Medicines Agency
Annex 11 compliance. Computerised systems, audit trail integrity, and access controls.
WHO
World Health Organization
Backup architecture, disaster recovery, and electronic record integrity for clinical trials
SAHPRA
SA Health Products Regulatory Authority
Local GCP compliance, data privacy alignment (POPIA), and IT vendor oversight for SA and multi-country trial sites
SPONSORS
International Sponsor Qualification Audits
Technical GxP IT audits by global pharma sponsors across EMEA. Vendor qualification, ITGC, and data integrity.
The GxP Practice

Who is behind
10-Bravo's
GxP practice?

20 years building and running IT inside Africa's leading clinical research organisations.

In regulated environments,
good enough
is not compliant.
The 10-Bravo GxP Standard
Get in touch

Let's talk about
your environment.

Whether you're managing day-to-day IT, preparing for an audit, or building for compliance from scratch. We'd love to hear from you.

Scroll to Top