Computer System Validation (CSV) and Data Integrity, according to ISPE GAMP 5 guidelines, ensure that automated software and systems operate in a secure, compliant and reproducible manner.
The framework uses a lifecycle approach that prioritises patient safety, product quality and data integrity, focusing testing efforts on high-risk system features. Systems are classified into software categories, from Category 3 non-configured software to Category 5 custom applications, to determine the required depth of qualification.
Following the V-model, validation examines electronic signatures and audit trails to verify compliance with data integrity standards.
Compliance Assessment & Regulatory Support
A structured, risk-based lifecycle approach aligned with GAMP 5 and applicable regulatory requirements, including 21 CFR Part 11, to verify and document that computerised systems consistently perform as intended, meet regulatory requirements and maintain data integrity.
Audit & Audit Support
A formal, structured assessment of computerised systems to verify their intended functionality, operational reliability, data integrity and compliance with applicable requirements, including FDA 21 CFR Part 11 and EU GMP Annex 11.
Remediation Services
Identifying, addressing and rectifying deficiencies in validation documentation, regulatory compliance gaps and data integrity issues in computerised systems, to support their continued compliance.
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