Agilent ChemStation Plus Instrument control, data analysis and data management

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Agilent ChemStation Plus Instrument control, data analysis and data management Slide 2 Topics Contents Overview ChemStation ChemStore Security Pack Method Validation Pack ChemAccess Summary Slide 3 What is ChemStation Plus? ChemStation Core-product for instrument control,data acquisition, simple data review & reporting + ChemStore ChemAccess Security Pack Method Validation Pack any of the following modules; ChemStore ChemAccess Security Pack Method Validation Pack = ChemStation Plus Overview Slide 4 Requirements Speeding up the advanced second-pass data review Including statistics, custom calculations, charting with control limits and powerful reports Hardware related performance data performance of each module, column quality, system suitability trends... Security Data storage (raw data and results) in ChemStation Plus is compliant with the latest rules of the FDA (21 CFR part 11) Long-term data storage and data management Built-in automatic archiving and backup tools help in handling large data amounts Analytical method validation Automated method validation from planning to overall validation report Overview Slide 5 ChemStation Plus offers... ChemStation Easy-to-use graphical user interface and full level-4 instrument control for a wide variety of chromatographic instruments. ChemStore Increases lab productivity by providing a tool for easy management of your chromatography data in a relational database. Security Pack Full support of your compliance needs to pass audits easily. Method Validation Pack Automated method validation according to USP, EP, ICH and FDA guidelines following the guidelines of 21 CFR part 11. ChemAccess for effective management and operation of a networked laboratory by providing remote system monitoring and control, plus centralized information storage. Overview Slide 6 ChemStation ChemStation Easy-to-use graphical user interface and full level-4 instrument control for a wide variety of chromatographic instruments. ChemStation Slide 7 Level-4 instrument control for multiple techniques Level-4 instrument control for: LC GC LC-MS CE* CE-MS* A/D-Converter LAN and GP-IB interfacing ChemStation Slide 8 Unique level-4 features Column ID tags for identification of the analytical column Micro chip stores all important columns information including an injection counter Storage of instrument firmware revisions and serial numbers Needed to fulfill the needs of 21 CFR Part 11 ChemStation Slide 9 Powerful data analysis Batch review for first-pass data review 3D data analysis with spectra evaluation, peak purity, spectra libraries and iso-plot ChemStation Slide 10 Diagnostics and EMF Maximising instrument up-time through: Automatic alerts for instrument maintenance Minimizes cost of ownership Advanced 1100 instrument diagnostics for fast and easy trouble- shooting ChemStation Slide 11 Fast and reliable instrument qualification Built-in verification package (OQ/PV) allows instrument qualification in less than an hour. Tests like wavelength calibration document the specified and actual values on paper and on disk. ChemStation Slide 12 Agilent ChemStore Database solution for single-user or networked ChemStations Increases lab productivity in the laboratory by providing a tool for easy management of your chromatography data in a relational database. ChemStore Slide 13 Data organization Data organized in studies Level of data storage defined per study Include your own custom fields in study to add supplemental data ChemStore Slide 14 Study-based data access and security levels The ChemStore study Highest organizational element On a study configurable data access for users Data security on a study level separate container for Part 11 and non-Part 11 data Study-based archival of data ChemStore Slide 15 Custom fields To add supplemental ChemStation data or non-chromatographic data Select from a pool of custom fields Define new fields of type True/false Selection list Integer or Real number Text Date/Time Selection list allows to specify a collection of default values ChemStore Slide 16 Result storage Data transfer is set up in the ChemStore menu Select destination study Define custom field values Use After each analysis for automated transfer Automatic data transfer after each run in single run or sequence mode, or Manual data transfer from Data Analysis screen AIA Import of data from other vendors system Note: with security pack, the transfer checkmark is set by default and can not be disabled! ChemStore Slide 17 Data review One query result for review, charting and reporting ChemStore Switch between sample- and compound-focused view Query and filter tool Review, table or charting view ChemStore report template creation tool Slide 18 Filter for query builder View studies allows users to query for data from all studies, or to restrict the data shown in the query dialog to data items only contained in a specific study ChemStore Slide 19 Control charting of results Define columns for table view and results to be charted at the same time Define upper and lower warning limits and critical limits ChemStore Slide 20 Statistical results review Get summary or regression statistics, for example, for compounds Customize your table to display results of interest Get summary statistics such as mean value, SD, %RSD or regression statistics Print the results or export to MS Excel Sort with two mouse-clicks ChemStore Slide 21 Custom calculations The ChemStore custom calculator facilitates: Cross-compound calculations (relative retention times, relative area) Calculations across two runs (concentration ratio) Calculations based on (statistical) results (average from repetitive injections) ChemStore Slide 22 Second pass data review Approval (A) Records who approved results and when Only authorized users Reject (R) Records who and when results rejected Batch (B) Runs to transfer back to ChemStation Controlled access for GLP ChemStore Slide 23 Batch creation Batch functions Select runs for a batch Select method Assign to a person Status of pending batches Smooth integration with the ChemStation Productivity gains Faster review, reprocessing Proper person performs the work Easy to learn and use ChemStore Slide 24 Report generation Integrated tool for report creation A variety of report templates already included For example, full-featured report similar to ChemStation Sequence Summary Report Chromatogram and spectra in report All calculations printed with report ChemStore Slide 25 Automated archiving Scheduled automatic archives Pre-defined queries and time intervals Checksum-protected XML catalog file Bi-directional generic archive interface List of defined archive queries ChemStore External archive management system Slide 26 Defining archive queries Selected set of criteria: archive query equals combination of criteria Archive name and file location Archive query condition Archive frequency ChemStore Slide 27 XML archive catalog Easy and fast retrieval of archives Generic XML catalog file For indexing of archives in archive management system simplifies retrieval Generated with each ChemStore archive unit Contains detailed information on the archive content: sample information (sample name, acquisition info) result information (results, approval status) (or other external archive management system) Managing ChemStore archives in Cerity ECM ChemStore TOC Slide 28 Security Pack For full support of your compliance needs to pass audits easily Your information Reporting Charting Calculations and statistics Security and compliance Archiving and organization Security Pack Slide 29 21 CFR Part 11 Limit Access Prevent data modification Change control Link Raw Data and Results Who did what when and why? Previous entries must not be obscured SecurityIntegrity Traceability Security Pack Slide 30 Part 11 Technical Controls Security Pack 11.10aSystems must be validated (P) 11.10bAccurate and complete copies (T) 11.10cProtection of records (P,T) 11.10dAccess limited to authorized individuals (P,T) 11.10eSecure, computer-generated, time-stamped audit trail (T) 11.10f/g/hChecks (device, authority, system checks) (T) 11.50Signature manifestations (T) 11.70Signature/record linking (T) 11.100Uniqueness of E-signature to individual (P,T) 11.200E-signature components and controls (P,T) 11.300Controls for identification codes and passwords (P,T) P = Procedural controls (usually the responsibility of the pharmaceutical company to develop) T = Technical controls (usually the responsibility of the supplier to develop) Slide 31 General rules for paperless record systems Security Pack 1.Appropriate control procedures for the laboratory (SOPs) 2.System that fulfills the FDA guidelines for electronic records and electronic signatures 1 + 2 = General rules for implementing a paperless record system Slide 32 System Validation (11.10a) Security Pack The systems used for the creation and maintenance of the electronic records must be validated 1.Validation by the vendor Development qualification 2.Validation by the user Formal acceptance testing Installation qualification Operational qualification (OQ/PV) Performance qualification Users may outsource validation services to the vendor Slide 33 System validation Security Pack Agilent validation services Installation Qualification (IQ) Operational Qualification (OQ) Procedures and documentation that meet the requirements of GLP, ISO 9000 and other regulatory agencies Slide 34 Limited system access (11.10d) Security Pack System access must be limited to authorized individuals 1. Procedural controls (SOPs) 2. Automatic system controls Slide 35 Managing access security Security Pack What? Accounts/groups? Password security? File security? Set inactivity timeout? How? Windows user management! Windows password policy! NTFS permissions! Time-based application lock! Slide 36 User management Mandatory login Complements NT security scheme Password p