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Pharmaceutical company with an outdated IT landscape
Outdated IT systems impaired data integrity and computer system validation and led to frequent data deviations.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Outdated IT systems impaired data integrity as well as computer system validation processes and led to frequent data deviations and inefficiencies in validation. Both fall under EU GMP Annex 11 and 21 CFR Part 11, which left an immediate exposure in regulatory audits.
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) →
Risk-based classification under GAMP 5 and the validation package from URS to PQ
Data Integrity Assurance →
Gap analysis of critical GxP systems and audit trail review to ALCOA+
21 CFR Part 11 & Data Integrity →
Part 11 gap analysis plus audit trail and e-signature design
Digitalization in Life Sciences →
A GMP-compliant roadmap and the validated introduction of LIMS, eQMS and MES
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Sources
- Entourage project experience (anonymized)
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