ORBIS Life Sciences Consulting
ORBIS Life Sciences Consulting
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    • Home
    • Services
    • Serialisation
    • Compliance
    • Resources
    • About Us
    • Careers

  • Home
  • Services
  • Serialisation
  • Compliance
  • Resources
  • About Us
  • Careers

GXP Audit Services

Process and Product Validation

Process and Product Validation

GxP assessment and process establishment

Perform audits for established GxP set ups 

Define remediation strategies for any gaps 

Determining regulatory inspection readiness

Perform RCA and CAPA for Regulatory audit findings 

Due diligence audit (Auditing customer’s supplier)

Process and Product Validation

Process and Product Validation

Process and Product Validation

Equipment Commissioning, Qualification and Validation 

Computer System Validation (CSV)

Progressive software validation as per NCA regulations

Retrospective validation for existing systems

21 CFR Part 11 / Annex 11 gap analysis and remediation

Laboratory Systems Qualification (GLP) 

GxP Solution Consulting

GxP Solution Consulting

GxP Solution Consulting

QMS Systems

DMS Systems

CAPA Systems

Service / Helpdesk Ticketing Systems

Training Automation Systems

QMS Remediation Services

GxP Solution Consulting

GxP Solution Consulting

SOP Gap Analysis

SOP Standardization

SOP Rationalisation

SOP Reconciliation and Optimization 

SOP Integration 

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Company registered in Ireland No.599229