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The auditing and assessment of data integrity is getting more and more relevant. This includes its coverage in authority inspections, external and internal audits, self-assessments and other type of assessments. Auditing and assessing data integrity is of paramount importance within the quality risk management of any life sciences company’s quality system.
There are many reasons for the growing relevance of data integrity, even though it is no new requirement. Some of them are:
the increasing usage of electronic records and signatures across the pharmaceutical and medical devices industry
the ever growing complexity of the IT landscape
the implementation of new technologies (e. g., Cloud Computing, Blockchain, Track & Trace, IoT)
the associated growing focus on data integrity in public authority inspections in the last years
evolving regulatory requirements and guidance as well as standards in technology
However, economic activities such as headcount reduction, efficiency and productivity optimization, outsourcing of processes and activities, growing complexity in the supply chain, etc. lead to an increasing importance of data integrity audit programs as well, as these can have a serious impact on data integrity.
The goal of this Webinar is to provide answers to the following questions:
What are typical inspection findings pertaining to data integrity?
What are the expectations/requirements of public authorities towards the auditing of data integrity?
How do I integrate data integrity into my audit planning?
Which measures can be taken during audit preparation?
Which approaches exist during audit execution to delve into this topic?
How do public authorities approach data integrity in their inspections?
The Webinar targets responsible individuals in quality assurance, quality control, audit departments, production and IT as well as other relevant departments being subject to inspections or audits, or auditing / assessing data integrity themselves.
Dr Thierry Dietrich serves in leading and consulting positions within the pharmaceutical and medical devices industries for more than 20 years. He founded pharm@dviser in 2016, and acts as management consultant. His areas of focus are data integrity auditing, auditing of IT suppliers and IT organizations, leading of large IT projects in GxP regulated areas, validation of computerized systems, as well as the building and optimization of quality management systems with focus on IT and data quality. Thierry Dietrich was/is leader resp. member of several GAMP® SIGs and ISPE. He also is the author of numerous technical publications, and speaker on technical conferences.