Hplc system site planning guide 4 of 31 ruoidv0154c. User documentation user documentation the user documentation aside from this system manual is provided as acrobat reader documents pdf located on the value solution chemstation software cdrom. Calibration standards must be used with every hplc analysis event. Is it possible to get various softwares or at least their user. In addition, they are carefully designed for broad applicability and easy operation. The user documentation aside from this system manual is provided as. Validation of computerised systems core document edqm.
This standard operating procedure sop details all the necessary individual steps involved in the hplc calibration. Install and operate all of the hplc system modules. Documented verification that a system operates according to. Can anyone help me to understand various hplc software. Do you need an installation qualification iq documentation. Sop on procedure for operation of hplc watersalliance. Which softwares are more commonly used for the method development purpose. Hplc software to quantify the concentration of analyte in the sample. This sop shall be applicable for the hplc system waters alliances 2690 2695 separation modules.
All necessary documentation requirements are listed on 22 pages standard operating procedure sop and its corresponding 8 attachments. Based on the user requirement, design, test plan and test. About the chemstation software 15 operating system 15 methods and sequences 15 system configuration 15 data model 16. Support documents and downloads waters corporation.
The information in this document is subject to change without notice and should not be. This sop template is ready to use and needs only a small amount of sitespecific modification. To make the best use of these forums, you should first become thoroughly acquainted with hplc fundamentals and concepts, then read the documentation supplied with your hplc system and. Acrobat reader documents pdf located on the value solution. Objective to lay down the procedure for operation of hplc waters alliance 2695 separation module scope to ensure that the instrument performs satisfactory and gives accurate and reproducible data. This sop is applicable for the procedure to be followed in hplc analysis and. The validation plan documents the process that is to demonstrate the equipment performs as intended. Liquid chromatography shimadzu hplc systems demonstrate high reliability, with outstanding performance, such as ultralow carryover and exceptional area reproducibility, and superior data quality. The certificate of validation shipped with each software package documents.
To describe the procedure to be followed in hplc analysis and documentation and to ensure that good laboratory practices are followed in the hplc analysis. Standard operating procedure of good laboratory practices for high performance liquid chromatography. Can anyone support me and discussion the agilent hplc. The hardware andor software described in this document are furnished under a license. Compliance services uhplc operation qualification oq knauer. Hplc calibration standard operation procedure youtube. Hplc calibration pharma gmp sop standard operation procedure. Hplc standard operating procedure last revised march, 3, 2016 this document is intended to be a guide for operating the garner labs hplc systems and is only intended to provide instructions for users who are already generally familiar with hplc operation. An audit trail to ensure the reliability of data and document email transmission functions. The qualification document installation qualification iq is part of the quality management system. The computerised system consists of the hardware, software, and network components, together. Biosystems engineering hplc standard operating procedure.