CSV Audit / Data Integrity Audits

Safe planning, implementation and
Follow-up of audits

GxP Compliance

CSV Audit / Data Integrity Audits

Audits are an integral part of the regulated environment in the life sciences, pharmaceutical and medical technology industries. Their preparation and implementation tie up many resources and require specific experience on the part of the auditor. Due to the advancing digitalisation, IT and CSV issues are increasingly becoming the focus of inspections by authorities and lead to numerous complaints. In addition to our more than 25 years of expertise in the validation of complex computerised systems, we have in-depth know-how and experience in the planning, implementation and follow-up of GMP audits and inspections.

DHC’s FIXED PRICE OFFERS

CSV Assessment

Is your CSV framework complete and robust?
For a fixed price, we offer you an assessment of your CSV framework in terms of completeness, robustness and up-to-dateness. After completion, you will receive a summary of the results with concrete recommendations for action.

Readiness Pre-Audit

Are you ready for inspection?
For a fixed price, we offer you a pre-audit to determine the status quo. We get an overview of your CSV framework and randomly check the system documentation. Afterwards, you will receive a summary of the results with concrete recommendations for action.

IT Infrastructure Assessment

Is your IT infrastructure qualification on a firm footing?

For a fixed price, we offer you a pre-audit to determine the status quo. We get an overview of your IT infrastructure qualification framework and randomly check the qualification documentation. After completion, you will receive a summary of the results with concrete recommendations for action.

Cloud Computing Assessment

What about the validation and compliance of your cloud solutions?

For a fixed price, we offer you an assessment of your supplier management and your CSV approach to cloud computing. We get an overview of your supplier management SOP, supplier qualification and qualification and validation strategy for cloud solutions. Afterwards, you will receive a summary of the results with concrete recommendations for action.

Data Integrity Assessment

Do you have data integrity under control?

For a fixed price, we offer you an assessment of your data governance system and a sample audit at system level. Afterwards, you will receive a summary of the results with concrete recommendations for action.

DHC CONSULTING SERVICES FOR CSV AUDITS AND INSPECTIONS

In addition to the basic packages, we offer a wide range of advisory services on the subject of “audits”. Here are a few examples:

  • Mock inspections in preparation for authority inspections
  • Audit Readiness Check
    • CSV Framework Check: review of your validation framework as well as your validation documentation for compliance
    • Analysis of the compliance of computer systems and IT infrastructure
    • Analysis of data integrity (set-up and implementation of data governance incl. audit trail review)
  • Periodic Reviews
    • System-related reviews (e.g. ERP, LIMS, eDMS, CDS)
    • Topic-related reviews (e.g. 21CFR Part11, data integrity, permissions)
  • Audit support
    • Support before, during and after authority inspections or customer audits
  • Conducting mandatory audits of suppliers, service providers and cloud service providers on their behalf

Feel free to contact us!

WHY CHOOSE DHC?

Make use of our experience and industry expertise as validation and data integrity specialists:

  • Over 25 years of expertise in computer system validation
  • A wealth of expertise in regulatory requirements
  • Broad-based experience with a very wide range of IT systems
  • Integrative approach adopted for existing QM systems
  • High level of knowledge transfer
Germany
Matthias Bothe

Managing Director & Industry Unit Manager
Life Sciences, Chemie and Medical Engineering
phone: +49 681 93 666 0
email: matthias.bothe@dhc-gmbh.com

Matthias Bothe, DHC GmbH
Switzerland
Carsten Buri

Director Sales & Marketing
phone: +41 44 500 888 7
email: carsten.buri@dhc-ag.ch

Carsten Buri, DHC AG
Request Information!

Learn more about our consulting services for GxP Compliance!

Customers

DHC WEBINARS

Our webinars are provided as a free service for DHC customers and potential customers.