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A unique Software Package for automatic Polarimeters
Up to now, no validated and certified software product had been available, the standalone operation of a Polarimeter (without computer) still is common and a paper hardcopy is the only way to store data. Although electronic Data-Handling is state of the art for all other analytical Instruments, in Polarimetry there was no chance to use modern computers for instrument control and storage of Polarimeter data. After numerous requests from Polarimeter users all over the world, Biolight has developed a revolutionary software package for Polarimetry. Biolight is an independent software house with long years of experience in the field of software for Analytical Instruments. Now a Pol WinLab, a Windows based software package for Polarimetry is available from Biolight. This software package is targeted to the specific needs of QA/QC labs in the regulated pharmaceutical market; it offers, however, also the flexibility, as it is needed for other industries and research applications. The specific demands of Pharmaceutical QA/QC labs concern all aspects of Pharmacopoeia and GLP/GMP compliance, of validation, of data security and data integrity. An important aspect is covered by CFR 21 part 11 that is dealing with electronic signatures, audit trail and generally with all security aspects associated with paperless data handling. Pol WinLab software package takes care of all these aspects and offers a simple but powerful means for routine Polarimeter measurement using modern data handling facilities. Pol WinLab software allows complete instrument control with data acquisition and storage. Both, Wavelength Program and Timedrive methods, come with a very powerful report generator and result calculator. The software package also includes instrument validation and pre-programmed methods for most common applications. The Software package offers full security features including electronic signature, password protected login, user rights and audit trail. There is an instrument driver available for full control for the PerkinElmer series 341/343 Polarimeters.
Pol WinLab Software is a modular package to cover the specific demands, needed in analytical Laboratories, especially in the regulated environment the software features a structured and controlled but nevertheless easy to use operation. Pol WinLab software package follows the standard procedure as it is typically used during method development, during approving process and finally in the daily measurement routine. A person experienced in the analytical methodology, the regulatory requirements, the specific lab requirements, the basic rules of data handling and general computer operation typically develops each method and each report template. This person often is the lab-manager or similar, who is able to implement or define standard operating procedures (SOP’s). A less trained person, not always overlooking all the technical background, often does the daily measurements. So the methods, once set up, should be easy to use and change of method-parameters and measurement data must be fully protected. Any deliberate or accidental manipulation must be documented to obtain fully compliant data integrity.
Administrator - Method Development and Report Customization with strict Data Security FeaturesDuring the use of Pol WinLab software package this process is strictly followed: The Administrator (= Lab manager or other experienced user) first sets up the methodology and the report templates. Then he tests the methods, After method development, the administrator will assign the methods to specific co-workers restricting the number of operation steps (user rights) according to the capabilities of the specific user. Thus the most restricted user level could just allow starting and stopping data acquisition with one specific method only. Pol WinLab comes with predefined 4 user levels:
To make sure that some typical measurements can be done without extensive method development, Pol WinLab comes with predefined, ready-to-run methods for the determination of:
Read - Data Acquisition made Easy For routine daily use and result measurements the operator will just simply log in his system and call up the method required. After start on the screen the required information for sample- preparation and handling and measurement procedures will appear (figure 3). Then Figure 4 shows an example for a report, obtained from the Method for measurement of Specific Rotation. Two samples had been measured, each sample with two replicates. The result includes all necessary measurement parameters, the raw data with the result and background information together with sample name and sample information. Average and standard deviation is calculated from the replicate measurements. The report shown in figure 4 can be customized this means each customer can configure the report according to his own requirements.
Validate - the Module for automated Instrument Validation Pol WinLab allows doing automatic Instrument Performance Validation using secondary or primary Quartz control plates. According to GLP and other regulations this process must be done in c Pol WinLab software will document all validation and will automatically prompt the user to do a validation after previously defined time- or operation intervals. This will assure that the instrument always is working in proper conditions and that a potential degrading of performance is discovered early. Figure 5 shows a measurement result, where one Quartz standards had been measured at four different wavelengths, including a pass / fail decision.
Status - the Display for quick Reading of single Rotation
Expert Read - the Module for Research and Method Development
The Expert Read is the ideal module for method development and optimization, for use by a real expert. All data security features are switched off in this module and the results do not contain an electronic signature, audit trail or any other reference to CFR requirements.
Specification and Hardware Requirements:Pol WinLab software is a Windows package running on PC’s with MS-Windows NT / Windows 2000 operating System. On these computers it offers full CFR compliance and full security features. The software will also run under MS-Windows 95/98/ME.The data security features, however, will not be available there. The structure of these operating systems do not support the strict security used in Pol WinLab.
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Polarimetry is an analytical technique for characterization of optically active compounds. It is frequently used for quality control of pharmaceutical drugs and prescriptions. National Pharmacopoeias prescribe use of Polarimetry for a wide range of pharmaceutically active compounds. Polarimetry is also used for research applications and sugar measurement. Typically Polarimeter measurements are being done with a standalone automatic Polarimeter with a printer connected. The measurement result just is documented on paper: no electronic storage is possible with this configuration. With the strong use of computers and networks in analytical laboratories there is an increasing demand of electronic data storage and computer control and also computerized method storage. Standalone instruments with printer are extremely non-flexible and appear to be old fashioned.
validates them and approves them for routine use. The methods will be archived when not needed anymore. This process of development, approval and archiving will be applied to all methods and report templates and is strictly followed in Pol WinLab software. Similarly the process of data collection is handled in Pol WinLab software. After measurement the data must be approved by the Administrator and can be sent to the archive, when required. All these operations are password protected and will be stamped with electronic signatures assuring full security and compliance. Additionally all manipulations are documented in a secure and fully protected audit trail.
the operator will be prompted to enter sample information, e.g. sample name, weight or concentration. Then the user will be prompted to enter blank and samples. Measurement will be performed and a customized report will be displayed, printed and stored. All this activity will be stamped with the operator’s electronic signature and will be documented in the audit trail. Finally the lab supervisor will check the reports and eventually approve them with his electronic signature.
ertain time intervals in order to assure full instrument performance. Pol WinLab includes a module, which allows to automate this validation process. First, of course, the lab supervisor will enter the reference data of the standard material used. These standards usually are quartz control plates with certified optical rotations. It also could be solutions of certain compounds with known optical rotation. Then the respective measurement information will be entered and the normal operator can do the validation measurement on a regular base. All rules of user rights, electronic signature and data security apply, as described for routine data acquisition. Pol WinLab will prompt the user to enter blank and standards. Measurement will then be initiated and the measurement results will be compared with the certified values. The software will then automatically make the pass / fail decision, based on instrument and standard tolerances entered previously by the lab supervisor. All this process is fully protected and documented with electronic signature and followed in the audit trail.
Another useful module of Pol WinLab is the status display. There you can see the life reading of the instrument, the wavelength and all the other measurement parameters the instrument is set to. This is a simple way to take a single reading, be it in optical rotation or degree sugar. The status is visualized on the instrument’s optical schematics (figure 6)
For users, without the necessity of CFR- or Pharmacopoeia compliance, for example in other industries or research applications, Pol WinLab offers a more open module, called Expert Read. This allows free method development, where all parameters can be varied and subsequent measurement with freely selectable parameters. Flexible measurement at up to 9 different wavelengths, Kinetics (time-based) or even temperature-based measure-ments are possible here.
