Compliance can be a productivity bottleneck for laboratories in regulated industries. Typically, five steps are required for full instrument, methods, and data validation. HP 1100 Series systems offer an extensive array of validation features to help laboratories meet even the most demanding regulatory and qualitystandard requirements without affecting productivity.

Step One: Validation at HP

HP designs, develops and validates products according to documented procedures. A Declaration of System Validation, shipped with each computer system, provides assurance that the system has been validated during development. Details of the procedure and evidence of successful development validation are available on request.

Step Two: Installation and Operation

HP ChemStation software includes procedures for selfverification of the HPLC hardware and HP ChemStation software. The user selects test items and acceptance criteria from a menu. Upon completion of these performance verification procedures, the user receives a full report documenting expected and actual results. Standard operating procedures for these tests are provided in electronic form for easy customization.

In addition, a holmium oxide filter is built into the UVVisible detectors for automated verification at different wavelengths. There is no need to fill the flow cell with a liquid calibration standard. The filter's wavelength accuracy and the chemical kits for performance verification are traceable to national standards.

Step Three: Method Validation

The HP ChemStation includes software for automated method validation. The user specifies parameters from a menu; the tasks are automatically executed and the results documented.

Step Four: System Performance

Optional database provides online quality control charts for chromatographic performance parameters

Critical chromatographic parameters - the resolution between two peaks, for example - can be measured automatically during routine operation, using standards or qualitycontrol samples. For easy review of system performance status, the HP ChemStation's optional database plots longterm quality control charts for chromatographic performance parameters and results, together with userdefined warning and action lines. Maintenance activities are documented in the instrument's electronic logbook.

Step Five: Security, Integrity, and Traceability

To assure security, HP provides passwordprotected user access. For data integrity and traceability, the software saves method parameters, instrument conditions such as pressure and temperature, instrument logbooks, column parameters (as recorded by the new column identification module), and instrument serial numbers, together with raw data in checksumprotected binary register files.

HPLC Hardware Verification Report

Test Item	User Limit	Actual	Com.
Test Method:	C:\HPCHEM\1\VERIF\Check M
Data File Directory:	C:\HPCHEM\1\VERIF\Result D
Original Operator:	Dr. Watson
DAD noise	<5 x 105 AU	10 x 105 AU	Pass
Baseline drift	<2 x 103 AU/hr	1.5 x 104 AU/hr	Pass
DAD WL calibration	±1 nm	±1 nm	Pass
DAD linearity	1.0 AU ± 5 %	1.5 AU ± 5 %	Pass
Pump performance	<0.3 % RSD RT	0.15 % RSD RT	Pass
Temp stability	± 0.15°C	±0.1°C	Pass
Precision of Peak area	<0.5 % RSD	0.35 % RSD	Pass
Verification Test Overall Results: Pass
HP 1100 Series System, Friday, November 10, 1995
Test Engineer
Name:		Signature:


Test Method:            C:\HPCHEM\1\VERIF\Check M

Data File Directory:    C:\HPCHEM\1\VERIF\Result D

Original Operator:      Dr. Watson



Test Item               User Limit        Actual            Com.               

DAD noise               <5 x 105 AU        10 x 105 AU      Pass        

Baseline drift          <2 x 103 AU/hr   1.5 x 104 AU/hr  Pass       

DAD WL calibration      ± 1 nm            ± 1 nm            Pass

DAD linearity           1.0 AU ± 5 %      1.5 AU ± 5 %      Pass          

Pump performance        <0.3 % RSD RT     0.15 % RSD RT     Pass   
   
Temp stability          ± 0.15°C          ± 0.1°C           Pass

Precision of            <0.5 % RSD        0.35 % RSD        Pass      

Peak area



Verification Test Overall Results: Pass

HP 1100 Series System, Friday, November 10, 1995



Test Engineer

Name:           Signature:

See Also

: How the HP 1100 Series HPLC Lowers the Cost of Ownership

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