Agilent offers a comprehensive set of Laboratory Compliance Services including Instrument and Software Qualifications (IQOQ, OQ and RQ) based on USP <1058> AIQ, and Compliance Consulting including custom validation services such as Computer System Validation (CSV) based on GAMP5 (Risk Based Approach and V Model) and Part/Annex 11 (Electronic Records and Signatures) as a foundation for Data Integrity.
Data Integrity is an increasing area of concern for laboratories who produce results subject to regulatory requirements. Regulated labs. in many industries must demonstrate and document the suitability of analytical instruments and software for their intended use. This focus on compliance extends into how the instrument and software performance is evaluated.
To help our customers ensure compliance in an increasingly stringent regulatory environment, Agilent CrossLab Group have developed an automated compliance solution designed to support the end-to-end Analytical Instrument Qualification (AIQ) process. The Automated Compliance Engine (ACE) is an electronic, audit-ready qualification solution
that addresses Data Integrity and USP <1058> AIQ requirements.
Additionally, Agilent offers custom validation services such as computer system validation
, audits/assessments, custom procedure writing, and more - giving you peace of mind about your Data Integrity, Qualification, and Computer System Validation (CSV) needs.