Product category:
Chromatographs: gas
News Release from: Agilent Technologies Europe
Edited by the Laboratorytalk Editorial
Team on 13 March 2003
Data system audit is online
Audit report on Agilent Cerity Networked Data System for pharmaceutical QA/QC is now available through Audit Repository Center website
Agilent Technologies Europe has announced that a qualified audit report on the Agilent Cerity Networked Data system (NDS) for pharmaceutical QA/QC is now available through the website of the Audit Repository Center (ARC) at www.auditcenter.com This report benefits pharmaceutical companies by providing the documentation required for response to a government audit of regulatory processes, thereby simplifying the audit response process, reducing costs and increasing productivity
This article was originally published on Laboratorytalk on 30 Jun 2008 at 8.00am (UK)
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The audit on the Agilent Cerity NDS for Pharmaceutical QA/QC product was performed according to the Parenteral Drug Association's Technical Report No 32 (PDA TR No.
32), and was prepared by a qualified auditor on behalf of a multinational pharmaceutical company.
The PDA TR No 32 defines a process for the auditing of suppliers providing computer products and services for regulated pharmaceutical operations.
The PDA has licensed the ARC to provide and maintain a central repository for sharing of audit information.
Supplier audits are an important measure for assessing and documenting the adequacy of the suppliers' development and support processes.
Agilent considers the standardised audit process model developed by the PDA to be an excellent means to address the requirements for supplier audits particularly in a climate of expense control, travel restrictions and time pressure.
Agilent Cerity NDS for Pharmaceutical QA/QC is a lab-specific software application that is designed for laboratories involved in routine quality assurance (QA) and quality control (QC) testing in the pharmaceutical industry.
The system implements the strict technical controls required by the US Food and Drug and Cosmetic Act ruling on electronic records and signatures (FDA 21 CFR Part 11) as well as other regulations and quality standards such as GMP, cGMP, Gamp, and ISO 17025.
The versatile, networked instrument capabilities combined with the fully scalable client-server architecture make the system a perfect fit for pharmaceutical QA/QC labs.
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