Be Compliant Consulting

Your compliance, our commitment

About us

MISSION STATEMENT

We support your organization’s compliance drive, giving you the benefit of over 20 years’ expertise in Quality and Validation. 


Be Compliant Consulting offers services in Quality Assurance (ISO 9001 and GxP), IT systems validation (CSV), data integrity (21 CFR Part 11), and data protection (ISO 27001, ISO 27002, etc.) for the pharmaceutical and life sciences sector.  


PHILOSOPHY

At Be Compliant Consulting, we believe that every client is unique, which is why we tailor our services to your context.


Our services

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Quality Assurance Consulting (GxP and ISO 9001 Scope)

  • Gap analysis – analysis of the gaps from the requirements and recommendations 
  • Quality Management System implementation 
  • Quality auditing 
  • Vendors & Suppliers assessments 
  • Document Management implementation 
  • Change Control, deviation & CAPA 
  • Continuous Improvement 
  • Risk Analysis (FMEA & ISO 31000) 


Computerized System Validation (CSV)

  • CSV Gap analysis – analysis of the gaps from the requirements and recommendations 
  • Data Integrity Gap analysis – analysis of the gaps from the requirements and recommendations 
  • Validation Procedural & Validation Documentations (VMP, SOPs, Working Instructions, URS, IQ, OQ, PQ plan, protocols and reports, etc.) 
  • Testing 
  • Defects 
  • Vendors & Suppliers assessments for cloud-based systems 
  • IT Change Control 
  • GDPR (advises) 
  • Risk Analysis (FMEA ,ISO 31000 & DPIA) 


More information?

Contact us now!

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Schedules

Mon - Fri
-
Sat - Sun
Closed