Case studyPharma

Data Integrity and CSV to FDA Audit Requirements

Pharmaceutical company with an outdated IT landscape

Outdated IT systems impaired data integrity and computer system validation and led to frequent data deviations.

The challenge

The situation

Outdated IT systems impaired data integrity as well as computer system validation processes and led to frequent data deviations and inefficiencies in validation. The resulting regulatory audit risk called for a comprehensive intervention.

Our approach

What we delivered

Remediation of the IT infrastructure as the basis for reliable data integrity

Establishment of standardized governance for validation and data

Controlled migration of data into the remediated system landscape

The outcome

Results & impact

39% fewer data deviations

Reduction in data deviations through remediated infrastructure and governance.

30% more validation output

Improved output of the validation processes.

FDA audit passed

An FDA audit was successfully passed after the intervention.

In summary

The company has a remediated system landscape under standardized governance, with markedly improved data integrity, confirmed by a passed FDA audit.

Related expertise

Computer System Validation (CSV) →

The case study addresses exactly the optimization of CSV processes and their standardization per GAMP 5 and EU GMP Annex 11.

Data Integrity Assurance →

The core topic of the case study is the sustainable safeguarding of data integrity per ALCOA+ principles in GxP systems.

21 CFR Part 11 & Data Integrity →

The passed FDA audit and the electronic records from the legacy-system remediation relate directly to the requirements of 21 CFR Part 11.

Digitalization in Life Sciences →

Replacing outdated IT systems with modern, GMP-compliant digital platforms corresponds directly to the digitalization approach in pharmaceutical production.

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Sources

Entourage project experience (anonymised)

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