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Where are you heading?

Quality Assurance Support


Regulations and Standards

Headway Quality Evolution can provide audit solutions in accordance with many regulations and standards...

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Good Laboratory Practice (GLP)

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Good Clinical Laboratory Practice (GCLP)

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Good Clinical Practice (GCP)

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Good Manufacturing Practice (GMP) Annex 13 

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ISO 9001

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ISO 17025

Research Areas

...in many fields of scientific research:

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Preclinical

  • Study Plan audits
  • Raw data and study report audits
  • In-life, system and facility audits
  • Vendor and subcontractor audits

Laboratory

  • Study Plan audits
  • Analytical data and report audits
  • Process, system and facility audits
  • Vendor and subcontractor audits
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Phase I Clinical

  • Trial Master File (TMF) and documentation audit
  • Process and study audits
  • Clinical Study Report (CSR) audit
  • Vendor and subcontractor audit

Agrochemicals

  • Study Plan audits
  • Remote field study site audits
  • Raw data and report audits
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Computer System Valdation (CSV)

  • Review of validation status of computerised systems
  • Audit of CSV documentation
  • 21CFR part 11 compliance
  • Electronic data management
  • Electronic SOPs