General Services Q-magine can offer a broad range of QA services from audits to Quality Management Systems consultancy: (Remote) Auditing Contract Research Organisations (CROs) Data Management and Biostatistics Service Provider Internal Systems Mock Regulatory Inspections Trial Master Files (TMFs) Investigator Site Audits Documents Consultancy GAP Analysis Quality Management Systems (QMSs) Development Regulatory Inspection Support Training   Specialised servicesDuring the last 10 years the environment for Clinical Research changed significantly. Clinical Research is now heavily depending...

Company Q-magine has been founded in August 2015. With Dr. Markus Wallstein as principle consultant the company can offer a broad range of QA services for the Life Sciences and the IT industry. Prior to setting up Q-magine GmbH Markus had been working for more than 12 years in various QA positions within different Pharmaceutical Companies conducting various types of GCP and IT audits within a broad range of countries and managing QA programs for various drug development projects. Within the last seven years Markus worked at ADAMAS Consulting on numerous audit and consultancy project assignments...

Specialised Service Providers/Supplier/Vendors Audits We can perform Software Supplier and Service Provider Qualification Audits to support organisations to make their best choice for their regulated activities. E.g. for: Electronic Case Report Forms (eCRFs) Electronical Clinical Outcome Assessment (eCOA), e.g. electronical Patient Reporting Outcome (ePRO) Electronic Electro Cardiogram (eECG) Lung Function Imaging Electronic TMFs (eTMFs) Safety Database Clinical Trial Management System (CTMS) Data Centre IT Operations Software Development Validation status audits of single...

Contract Research Organisations Audits Outsourcing is a common topic within clinical research. We can help you assessing the overall compliance status of Contract Research Organisations tailored to you specific needs and the services you are planning to outsource. We have experience in auditing specific services as e.g. Data Management and Biostatistics in applicable detail Data Management and Biostatistics Systems Audits We have experience in Data Management and Biostatistics audits. This is true for specialised service providers as well as internal organisations within big pharmaceutical...

Q-magine has been founded in August 2015. With Dr. Markus Wallstein as principle consultant the company can offer a broad range of QA services for the Life Sciences and the IT industry. Prior to setting up Q-magine GmbH Markus had been working for more than 12 years in various QA positions within different Pharmaceutical Companies conducting various types of GCP and IT audits within a broad range of countries and managing QA programs for various drug development projects. Within the last seven years Markus worked at ADAMAS Consulting on numerous audit and consultancy project assignments for...

Bild 2 bild 2 Q-magine provides outstanding and independent QA services for the Pharmaceutical and Lifesciences Industry Bild 1 bild 1 Q-magine offers Auditing services covering Good Clinical Practice (GCP), and for IT systems GCP, Good Laboratory Practice (GLP) and Good Vigilance Practice (GVP) Bild 4 bild 4 Beside auditing Q-magine provides Quality Management Systems consultancy services Bild 3 bild 3 Q-magine offers specialised QA services paying particular attention to the compliance...