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Integrity Solutions Europe
T.
+44 (0) 20 8793 9531
F.
+44 (0) 20 8793 9531
E.
contact@integrity-solutions.co.uk
Integrity Solutions Japan
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+81-3-6420-0775
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+81-3-6420-0162
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contact@integrity-solutions.co.jp
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Testimonials

"Responsive, reliable and knowledgeable.  Integrity Solutions have been a great partner in projects we have undertaken together at Allergan"
Ka-Wai Chan, R&D Information Systems, EU and AP

Case Studies

BACKGROUND

  • Globally, ensure compliance of all computerised systems  with current regulatory expectations
  • Business, process, laboratory & clinical systems
  • R&D, Manufacturing, Distribution and Pharmacovigilance
  • Managed resource across 3 continents

OBJECTIVES

  • Maximise business value from retrospective effort e.g.  greater process /system understanding, reduced operation and maintenance costs
  • Knowledge transfer ensuring client is self sufficient post project
  • Establish infrastructure for future cost effective validation

ROLE

  • Establish and manage integrated project team comprising client and ISL resource
  • Train client organisation in current regulatory requirementsEstablish risk based quality, CSV, ERES, Infrastructure, Security policies / standards. 
  • Implement gap analysis toolset
  • Establish “expert circle” to ensure consistency and resolve issues
  • Cross site audits to ensure consistency of assessments and risk
  • Establish and execute risk based plans to remediate systems

OUTCOMES

  • Minimum documentation set established for all systems
  • Critical functions and performance criteria determined and tested
  • Quality processes for ongoing management of systems established
  • Clarity of accountabilities for CSV and operation established
  • Systems rationalised where possible

CHALLENGES

  • Establishing a consistent perspective of risk across business functions, regions and sites
  • Securing dedicated client resource
  • Maintaining priority against other business improvement initiatives
  • Securing investment into extensive training programme

BENEFITS

  • Successful regulatory inspections post project
  • Greater understanding of processes and patient risks
  • Lower prospective validation costs through adoption of risk based approach, integrated validation, knowledge and clarity of accountabilities
  • Greater control over system maintenance