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View additional product information for Watson™ LIMS™ Software - FAQs (INF-21000)
29 product FAQs found
To perform and review Standard Regression Analysis for PK Studies and an Immune Response Analysis for ADA we recommend the following:
PK Studies:
Import raw results.
Perform Standard Regression Analysis to calculate the calibration curve and regression parameters.
Use a Run Acceptance Template to verify run acceptance criteria.
Review the Curve, Standards, and QCs. Flag ALQ and BLQ samples, and tag samples for re-assay if needed.
Save the form.
A second user reviews and accepts the results.
ADA Studies:
Follow a similar process as PK studies.
Perform Immune Response Analysis.
The first operator assesses and saves the form.
A second operator reviews and accepts the results.
Watson LIMS Software manages multiple aliquots, called splits, of the same sample. This can be done both manually and by importing information through spreadsheet files.
You can use the Export function to export all data in the Explorer to one of the following formats: Excel, CSV, Rich Text Format, PDF and single web page file.
For files exported by Watson LIMS Software, the system cannot add a checksum.
For files exported by another system to be imported by Watson LIMS, the ability of the system to add a checksum depends.
- Watson LIMS supports, through Integration Manager, the SOFT-interface (Secure Open-standard File Transfer) which works with Digital Signatures, which is more secure than a checksum. Currently, only a limited number of suppliers support this format. For build-in interfaces, no file validation is performed.
- For other interfaces implemented via Integration Manager a file verification is not standard, but can be added; this requires further input and collaboration from the instrument vendor.
Watson LIMS Software can use LDAP and SSO for authentication.
Watson LIMS Software is able to ensure accurate, complete, reliable, and compliant records and data throughout the data life cycle.
Watson LIMS Software is able to receive and store samples. These include locations and any further movement.
Data is stored in a secured Oracle database.
There’s no additional cost for two additional non-productive systems (like DEV and VAL). These systems will only get a limited number of licenses (10% of the total). During the project phase a full set of licenses will be granted. If deployment tools are required (hosting fees, remoteApp, and licenses for Windows / Oracle, etc…) these will be charged separately.
Watson LIMS Software allows you to apply comments to samples in the Worklist > All Samples Tab either by selecting from the drop-down list or by entering free text. This comment can be for any reason you choose.
All Project ID’s/Plate IDs/Assay IDs that are generated by the system are unique.
Sample Conditions within Watson LIMS Software includes Not Received, OK, and In Run. The condition changes automatically as you process. It is possible to add other sample conditions through the Watson Libraries, allowing you to manage your samples more accurately.
Authorized results can be exported through the Custom Results Export Feature. Custom Results Export produces a file of sample results with a customizable variety of information associated with each result.
Watson LIMS Software has dozens of built-in file-based interfaces that can be used (Softmax Pro, MSD {single analyte}, Tecan, Sciex, Masslynx, etc.)
Besides the digital interface for Sciex Analyst, various so-called “gateways” are available for direct interfaces: LCQuan, XCalibur, Thermo Scientific TraceFinder Software, Thermo Scientific Chromeleon Chromatography Data System (CDS) Software, Empower.
Integration Manager provides bi-directional interfaces between LIMS, CDS, instruments and enterprise systems to allow automated data transfers from lab instruments into Watson LIMS Software.
Waters UNIFI is connected to Integration Manager in a file-less manner.
Thermo Fisher Scientific supports the SOFT-interface (Secure Open-standard File Transfer), which is a digitally signed (hence secured), standardized xml-file for interfacing between LIMS and instrument software.
For all other instruments a file-based transfer is possible using Integration Manager. This has been done for numerous instruments (MSD, Softmax Pro, Tecan, Simoa, Ella, Luminex, MassHunter, etc..)
Incurred Sample Repeats (ISR) sample selection can be randomly selected based on the results, whereby ALQ and/or BLQ results can be filtered out prior to the random selection. However, according to industry guidelines [ICH-M10] the minimum number of ISR is a dynamic rule:
- 10% of first 1,000 samples; 5% of all samples above 1,000
- randomly selected subjects
- adequate coverage of the concentration profile is important.
This pseudo-randomization makes it difficult to build into the system and most customers tag samples for ISR manually, so that they can be found more easily when selecting samples for a next run.
Watson LIMS Software is able to import samples from an import file. This can be done by the use of an excel file, for example.
Watson LIMS Software allows for backup, archiving, and restore operations to be tracked and documented within the audit trail.
Watson LIMS Software ensures that GxP related actions are performed in the correct sequence.
Assay reports within Watson LIMS Software that are generated can be saved and printed.
Within Watson LIMS Software, additional information can be added including Assay Type, Assay Date, Biological Matrix, Species, Analyte, Instrument type/interface, Operator and more.
Within Watson LIMS Software, flexible study designs are defined using a built-in protocol builder, using template-based study protocol import, and import using an API. This allows for the import of custom barcodes to keep track of protocol amendments and for Sample Design Reconciliation.
There are many different study actions available depending on the status of a study. Some of these include Archive Study, Assign Security, Configuration, Delete/Edit Study, Import/Export, Reassign Study, Rename Study, Study Analytes, Lock/Unlock Study, Electronic Signatures, Study Audit Report, Study Level Retriever Reports and Document Management System.
Once the Study is completed, it can be locked. Upon locking a separate (configurable) security role becomes active and will limit most actions to a Study – but will typically allow access to all reports. It’s also possible to revoke access to the Study for all users, except the archivist.
Watson LIMS Software is able to create and open Calibration, QC and Test Batches with or without spikes.
Watson LIMS Software allows the reason for change to be logged. Also, in the use of electronic signatures, a reason for carrying out a change is presented as part of the audit trail and to keep track of any changes made.
Stability samples can be managed if they are defined as stability samples. Stability samples are samples that are maintained under strict conditions to assess the effect of environmental parameters such as temperature, humidity or freeze/thaw cycles. They can be processed in the same way as study samples and can be used in all types of analytical runs.
Samples are able to be sorted by multiple fields including day and time during both creation of a worklist and result review.
Watson LIMS Software is able to use barcode identifier (including 2D codes and QR codes) for sample identification.
Watson LIMS Software is able to create multi analyte sequences in 96 and 384 wells plates.
Yes, QCs are known as “Analytical Samples” and can be created in a batch. Labels can be generated and (optionally) QC-samples are tracked in the Sample Management area of Watson LIMS Software. As such QC-samples can be ‘received’, transferred and tracked for F/T-parameters and used in Stability Reports and other Method Validation Reports. It can be configured that after single use the QC-sample will be “consumed”.