Over 600 audits in 23 countries

GXP Engaged Experience

Recent examples of Auditing and Trial QM Oversight

Sponsor Location

Scope of Work

Tasks

No. of Audits

Target Countries

Germany

Qualification of Suppliers,
On-site audits

Supplier audits, On-site audits

8

Greece, Portugal, Spain, France

Austria

Qualification of Suppliers

Supplier audits

2

US

Austria

Qualification of Suppliers

Supplier audits

2

Germany, Austria

Israel

Qualification of Suppliers

Supplier audits

2

Germany

UK

Qualification of Suppliers

Supplier audit

2

Denmark, France

Switzerland

Qualification of Suppliers

Supplier audits

4

Sweden, Germany

Germany

Qualification of supplier

Audit of medical device company

1

UK

US

QA surveillance

Audit of sites, Support trial QA

15

Europe and Russia

Spain

QA surveillance

Supplier audits, Audit of Sites

6

Germany, Austria, Poland

Austria

QA surveillance

Supplier audits, Audit of sites, Support trial QA

25

Russia, Romania, Austria, Germany, India, Baltic States

Germany

QA surveillance

Audit of sites, TMF audits, support trial QA

8

Germany

Germany

QA surveillance

Audit of sites, QA trial oversight

2

Germany, Slovakia

US

QA surveillance

Audit of sites, QA trial oversight

15

India, Germany

Switzerland

QA surveillance

Support of local offices for global acting sponsor

1

Germany, Austria, UK, Ireland

Germany

QA surveillance

Support of Central Imaging company for all QA aspects

2

Germany

Germany

QA surveillance

Support of sponsor company for all GCP QA aspects

3

Germany

Switzerland/US

QA surveillance

Audit of sites

7

Germany, UK, Hungary, France, Sweden

Austria

QA surveillance

Audit of sites

10

Europe

Germany

Documentation audits

Audit of Clinical Study Reports

10

Germany

Austria

Inspection preparation (EMA)

Training and audit of two sponsor locations

2

Switzerland, Austria

US

Inspection preparation (FDA)

Training and audit of laboratories and sites, root cause analysis of results, inspection participation

10

India, Singapore

Austria

Inspection preparation (FDA and EMA)

Training and audit of sites

5

Russia, Poland

Germany

Inspection preparation (FDA)

Training and audit of sites, inspection participation, inspection participation

3

Germany

Austria

Inspection preparation (EMA)

Audit of site

1

Austria

Austria

Inspection preparation (FDA)

Audit of site

1

Russia

 

Recent examples of QM System Evaluation and Upgrade Support

Company

No. of SOPS

No. of Forms

Scope of Work

Tasks

Switzerland

10
-

Clinical Research + Pharmacovigilance

SOP writing

Germany

45

75

Clinical Research

Review of existing, Writing of additional SOPs

Switzerland

36

46

Clinical Research + Pharmacovigilance

SOP writing

Switzerland

31

44

Clinical Research

Establishment of new QM system incl SOPs

Austria

30

52

Clinical Research

Establishment of new QM system incl SOPs

Germany

26

44

Clinical Research + Administration

SOP writing and updating

Austria

25

-

Clinical Research + Pharmacovigilance

Establishment of new QM system incl SOPs

Germany

10

25

Clinical Research

SOP writing

Germany

32

-

Clinical Research

Establishment of new QM system incl SOPs

France

76

Ca. 180

Clinical Research

Establishment of new QM system incl SOPs

Belgium

22

47

Clinical Research, Pharmacovigilance, Regulatory Affairs, Human Resources, Finance, Sales and Marketing

Establishment of a new QM system incl Quality Manual and SOPs