Agilent approach of using ACE for Qualification

Hi Lakshmi,

Here is the reply from our compliance group....

Traceability and Audit Trails

Data are generated by the same native chromatography data system (CDS) used in the daily operation of the instrument, which controls the system being qualified during the complete qualification process. At no time is this connection severed or altered in any way. The CDS audit trail maintains a record of the complete interaction with the system under qualification. The creation and access of data files are captured in the CDS audit trail and are subject to the access controls specified in the firm’s Standard Operating Procedure.

 Data Processing and Reporting

Data are processed using the calculation engine built into ACE. All quality decisions about the pass/fail status of tests performed during a qualification are automatically executed within the ACE software. This provides a consistent and harmonized approach to all qualification records for all systems and techniques irrespective of their controlling CDS, with the added benefit of an independent assessment of system performance—not one conditioned by the native CDS.

ACE automatically creates an electronic Equipment Qualification Report (EQR) that includes a summary of test conditions and pass/fail results. The EQR is delivered as a secured .pdf file electronically signed by the Agilent service representative. The report includes a graphical representation of the electronically embedded chromatograms and shows the integration results. A complete set of electronic data and metadata used in all tests is delivered to the customer upon completion. A counter is incremented each time a specific test is processed and is included in the test summary as an effective electronic deviation. If a test must be repeated, the failed test results are available optionally as attachments to the EQR upon customer request.

 See the following white paper for further details - Data Integrity in Qualification Services (https://www.agilent.com/cs/library/whitepaper/public/5991-3652EN.pdf)

Hi Lakshmi,

Here is the reply from our compliance group....

Traceability and Audit Trails

Data are generated by the same native chromatography data system (CDS) used in the daily operation of the instrument, which controls the system being qualified during the complete qualification process. At no time is this connection severed or altered in any way. The CDS audit trail maintains a record of the complete interaction with the system under qualification. The creation and access of data files are captured in the CDS audit trail and are subject to the access controls specified in the firm’s Standard Operating Procedure.

 Data Processing and Reporting

Data are processed using the calculation engine built into ACE. All quality decisions about the pass/fail status of tests performed during a qualification are automatically executed within the ACE software. This provides a consistent and harmonized approach to all qualification records for all systems and techniques irrespective of their controlling CDS, with the added benefit of an independent assessment of system performance—not one conditioned by the native CDS.

ACE automatically creates an electronic Equipment Qualification Report (EQR) that includes a summary of test conditions and pass/fail results. The EQR is delivered as a secured .pdf file electronically signed by the Agilent service representative. The report includes a graphical representation of the electronically embedded chromatograms and shows the integration results. A complete set of electronic data and metadata used in all tests is delivered to the customer upon completion. A counter is incremented each time a specific test is processed and is included in the test summary as an effective electronic deviation. If a test must be repeated, the failed test results are available optionally as attachments to the EQR upon customer request.

 See the following white paper for further details - Data Integrity in Qualification Services (https://www.agilent.com/cs/library/whitepaper/public/5991-3652EN.pdf)