QSI UK – Standard Functionality

From QSIUK

With over 700 successful LIMS installations world wide, QSI have accumulated vast experience of user needs and have developed functionality that will satisfy almost any LIMS requirement. Now this unrivalled experience has been distilled into the first truly feature rich "Out Of The Box" LIMS package, capable of satisfying the diverse but specific needs of a wide range of user industries. All the functionality likely to be required for the different types of laboratory and industry sectors is in the core WinLIMS system.

The following list briefly describes some of the available functionality.

Contents 1 Sample Login 2 Results Entry 3 Specifications 4 Work Resourcing 5 Sample Receipt and Barcoding 6 Validation and Approval 7 Security 8 Reporting 9 Methods 10 Quotations and Invoicing 11 Specialised Industry Specific Applications

Sample Login

Single Sample Login

Enables users to register a single sample. The registration process allows the user to identify a sample and automatically assign tests and their product-specific limits (if desired) using simple point and click operation.

Batch Sample Login

Provides a means for registering multiple samples using a single form. This is normally used when a series of samples are to be associated with each other. Within production facilities the batch is normally based on a production lot; whereas, in research or analytical services laboratories the samples may be associated based on a specific work request, job or submission.

Automatic Sample Scheduling

This permits users to specify automatic sample login times. The automatic login of samples is performed on the basis of Sample Type (or Product Specification). Assignment of tasks is accomplished through a simple table entry on the basis of time, data, date, week or month. Samples will be automatically logged into WinLIMS™ at the specified time & day and given the status of N (New sample logged, but not received in the laboratory).

Automatic Batch and Sample login from ERP / MRP Systems

Batches can be automatically logged into WinLIMS via the WinLIMS MRP/ERP interface. Once the batch has been logged, samples are logged against the batch based on the appropriate sampling rules.

Associated Projects

WinLIMS enables the creation and control of projects. The projects are generally related to research and development studies or new product development. Once a project has been defined with all the require project information, samples and batches can be logged against the project, thereby providing overall project reporting.

Results Entry

By Sample

Within some laboratories it is convenient to view all of the sample information while entering analytical results. Laboratories use this mode of results entry when it is beneficial to have a full perspective of the sample being tested at the time of results entry. WinLIMS™ provides a mode of results entry whereby the user may select a single sample using one or more of its descriptive identifiers. When the sample is selected a listing of all of the required results will be presented for data review and entry.

By Method

When laboratories assign their work to analysts by test method, the WinLIMS™ Results Entry by Method function may be used. This function permits a user to select a specific test method and be instantly presented with a spreadsheet-like form that contains all samples for which results for the selected test have not been entered. Users then enter results for a large number of samples in an efficient manner.

By CrossTab

A powerful tool for quality and process control laboratories or any other laboratory where it is desirable to view results from a number of related samples. Results Entry by Cross tables allows the user to select the identifiers that associate a number of samples. Upon making the selection, the results of all of the related samples will be presented on the form in a cross tabular fashion for data review and/or results entry.

By Batch

At times it is essential that all analyses that are performed be organized within analytical batches, which group series of samples together. Within WinLIMS™ analytical batches are uniquely identified, and associated with the instrument used to acquire the data. Within the batch, the positions at which all calibration, control, quality assurance and unknown samples are recorded and results are time and date stamped to provide a complete audit trail for analytical batches. The quality data is automatically associated with the selected instrument to provide a continuous control charting for all analytical equipment.

By Instrument Acquisition

Interfacing instruments to WinLIMS improves the efficiency of laboratory staff members while reducing or eliminating data transposition errors. QSI's instrument interfacing software enables end users to configure their own interfaces to instruments or to files that are produced by instruments, spreadsheets or 3rd party data acquisition tools. This cost-effective option often provides the payback required to justify the purchase of your WinLIMS software.

Bi-directional Instrument Interfacing

InterLink, a user configurable WinLIMS application which can provide bi-directional interfacing to instruments or their controlling PC's. The bi-directional capability means that the interface can send sample queues from WinLIMS to the instruments, as well as acquiring the sample results.The following are just a few of the instrument types successfully interfaced with WinLIMS. HPLC, GC, NMR, ICP, NIR, XRF, Titrators, Viscometers, Densitometers, Pour Point, Mass Spec, Karl Fischer, Kone, etc.

Integrated Graphical and Statistical Trending

Statistical graphing is available within the WinLIMS results entry forms, for example when reviewing a sample the user can highlight a result parameter and click the graphs button. This action will select results for the method parameter highlighted for the product being tested and then graph those results and calculate standard statistics based on the results. This tool can be used for trend analysis, SQC, and SPC.

Specifications

Specification Management

In most laboratories methods are assigned to samples based on the type of sample submitted. Hence specification management enables the assignment of methods to the sample type specification and sets of limits for each of the methods parameters. These limits will be used to check the results entered for the specific sample type being tested. Specifications can be created for the following various types of samples suchas: raw materials, finished products, environmental, research and development and more… All specifications are fully version controlled.

Customer Specification Matching

Many companies manufacture bulk products, which are then sold on to a number of different customers. Many of these customers have differing specification and certificate of analysis requirements for the same bulk product. WinLIMS allows the creation of a QA manufacturing specification which is used for the release of the bulk product and then allows the creation and assignment of customers specifications to the QA specification. Hence when an order is received for a bulk product, the customer can be selected and WinLIMS can automatically compare the QA results to the customers specification and if in specification automatically print the certificate of analysis in the format required by the customer.

Product Regrade

Product re-grade in association with the customer specifications provides a logistics tool. This tool enables the user to check when a product batch is out of specification whether the product will still meet the requirements of any of the customers specifications for that product. If the batch does meet the requirement of one or more customers, then the batch can be re-graded and a disposition made against the batch to indicate resale only to those customers.

Associated Material Safety Data Sheets

Material safety data sheets can be created and maintained within WinLIMS. Once created the MSDS can be associated with raw materials and product specifications, hence when processing a sample the MSDS information is attached to the sample, warning the technician of any dangers and handling precautions.

Formulations and Recipe Control

Product and intermediate product formulations can be created within WinLIMS. The formula for a product is associated with the product specification, and contains the ingredient list and quantities for each ingredient. The production steps that have to be taken to manufacture the product are also recorded against the formulation. This formulation information is then available for other WinLIMS functions such as works order batch login, blend corrections, or recipe pre-weigh etc.

Reduced Testing

The WinLIMS Reduced Testing & Audit functionality provides manufacturing companies the functionality to define reduced testing schedules for samples or batches. The system will keep count of samples or batches logged into WinLIMS for each raw material. Within the testing schedule the user can define the testing regime, i.e. test every 5th batch/sample and also what tests should be applied, hence when the count reaches the number defined within the reduced testing schedule the batch or sample would be tested.

Work Resourcing

Work Allocation

Samples to be processed can be allocated to available resources, these resources can be technicians, laboratories, or instruments. This enables the management of available resources.

Worksheet Production

A wide variety of worksheets are available which may be used to help the laboratory efficiently process samples. Worksheets may be organized by lab, by individual, by instrument or any other logical criteria. The worksheets may be presented on the screen, printed to hardcopy or passed to an analytical instrument for automatic run generation.

Sample Receipt and Barcoding

Sample Receipt

It is possible for samples to be logged into WinLIMS™ by users who are not physically located within the laboratory -or- automatically via automatic schedule or MRP/ERP interface. When this happens it is essential for WinLIMS™ to record when the laboratory receives the samples since testing cannot begin until the lab actually has the samples in-hand. The sample receipt function enables the laboratory to record when the sample was received and by whom. This information may be used to calculate laboratory turnaround times within management reports.

Barcode Sample Receipt

This performs the same function as the Sample Receipt function; however, instead of clicking on a form to identify the sample, a barcode label containing the sample’s unique identifier would be scanned, to confirm receipt in a quick and efficient manner.

Barcode Label Printing

Barcode labels can be printed automatically on the login of batches or samples. The design of the labels to be printed is under the control of the selected WinLIMS user, the labels can contain both human readable text as well as barcodes.

Validation and Approval

Results Validation

In many laboratories it is standard operating procedure to require results that were entered into WinLIMS™ to be reviewed by a peer or a supervisory staff member. This is often the case within pharmaceutical, food or any other regulated laboratory. When this level of data review is not required, or if data is only reviewed when it does not meet its specification requirements, the results validation step may be bypassed.

Sample Approval

The sample approval step is used to confirm that the sample's testing cycle has ended and the laboratory management has given the sample a final disposition. The disposition of samples will differ from lab to lab; however, most laboratories assign disposition statuses, which include Approved, Rejected, Reworked, Cancelled, Concession, etc. This lets the rest of the organization know what was determined by virtue of the laboratory's testing of the sample.

Batch Approval

Where companies process batches such as raw materials or manufacturing orders, batch approval routines exist to attach final disposition statuses. The final disposition would be based on the results of all the samples attached to the batch.

Security

Centralised Multi-Site and Multi-Laboratory Control

The WinLIMS Multi-Site Option is designed to enable a single WinLIMS™ implementation to restrict access to information and functions to individual laboratory groups. This is especially useful when operating multiple sites within a single database over a Wide Area Network (WAN).

User Privileges

The security and user privileges manager allows the system administrator to determine the level of security that will be used by their WinLIMS system. The security management system retains an easy to use interface, while adding the features of 128-bit password encryption and great refinement in user access.

Electronic Signatures

WinLIMS complies with (FDA regulation 21 CFR Part 11) requirement for electronic signatures which provides additional security to key transactions. The electronic signatures functionality allows the administrator to define what transactions require electronic signatures.

Audit Trails

WinLIMS complies with (FDA regulation 21 CFR Part 11) requirement for audit trails. Audit trails can be applied to any of the tables within WinLIMS and will audit any addition, update, or deletion of the records within the table. Audit trailing can be transparent to the user automatically recording user date and time or can prompt the user for comments.

Training and Qualifications

The WinLIMS Staff Training functionality permits your company to keep detailed training records for all of your staff members. By virtue of the training courses attended, your staff members are granted qualifications in a manner that is consistent with record keeping requirements for GLP and ISO9000. By virtue of training, analysts are granted the ability to enter results for only those testing procedures for which they have been trained.

Reporting

Report Generation

QSI recommends and provides integration for Crystal Reports due to its ability to work with all of the WinLIMS™' supported databases, its powerful functionality and its affordable price. Many laboratories now require on demand web based reporting, to fulfill this requirement QSI has become an OEM partner with Business Objects so that we can supply Business Objects Enterprise XI web reporting tools at an affordable price.

Sample and Batch Certification

The production of certificates of analysis for both samples and batches can be controlled by the certification functionality. Once samples are certified the required certificates of analysis are printed automatically and the samples statuses updated to indicate that they have been certified and the certificates printed.

Methods

Methods Development

Method development permits you to enter the information required forall of your laboratory's analytical methods in a complete, well structured format.The following are some of the details recorded; result parameters, instrument, instrument detection range, calculations, etc.. Methods records are fully version controlled.

Results Calculation Engine

Virtually all mathematical functions are supported, including Boolean algebra: functions such as [IF], [THEN] etc, especially useful when working in the GLP or GMP environments. The software’s exceptional flexibility allows calculation routines that can use numeric values from anywhere within the WinLIMS tables, enabling techniques such as “cross sample” calculation, i.e. the ability to incorporate results from one sample in the calculation of results for another. An example of this might be the application of correction coefficients – tracking the performance of an analysis against calibration standards – to correct results “on the fly” at any time in a series of measurements.

Confirmatory Testing

The WinLIMS Confirmatory Testing Option permits users to automatically assign supplemental tests to samples when a result on a previous test falls outside specified limits. This allows you to "chain" tests together so that if the initial test fails then the confirmatory test is automatically assigned to the sample.

Consumables Stock Control

The consumables or materials that are used in the laboratory can be recorded within the materials table, including who the suppliers are, the costs, opening stock numbers, and re-order levels. The consumables and quantities that are used in the execution of a method can be defined as part of the method. Hence when a method has been performed on a sample the consumables used will have the stock levels reduced accordingly. Once re-order levels have been reached, the user will be prompted by WinLIMS.

Instrument Calibration and Control

WinLIMS provides integrated functions, which allow users to define and closely monitor each of the instruments that are used for performing the methods analysis. The function provides an on-line means for recording all instrument maintenance records for instant scheduling of maintenance events and on-line recall of past events. In addition, the function also enables users to record results from all calibration and QC samples that were run on each instrument in order to maintain data on-line for monitoring both usage and performance. Instant SQC charts for each instrument may be presented to provide a clear, graphic illustration of instrument performance to detect trends and take a proactive role to prevent instrument-related problems.

Quotations and Invoicing

Contacts Management

The WinLIMS contacts manager enables the creation of contact information for any individuals or companies that interface with the laboratory. The cotacts can be stored in an multiple tiered structure, hence one could have a parent company record, divisions of the parent and sub divisions of each division, as there is no limitation of the number of tiers, this provided total flexibility. These contact records are then made available throughout the other WinLIMS applications to avoid addition data input, such as quotations and sample login.

Quotation and Invoice Production

The quotation and invoice functionality provides the production of quotations and invoices for samples or groups of samples. Customer specific pricelists can also be maintained, which are then available for the quotations and invoices.

Specialised Industry Specific Applications

Used Oil Analysis

The used oil analysis function maintains a tiered historical record for each piece of equipment and can monitor its condition against its own unique set of specifications. Totally flexible specification handling means that the system can accommodate different rules for different customers, changes in plant operations and other variables. Reports can be generated to show current and historical data in tabular or graphical form, highlighting any out-of-spec results together with engineers’ comments and any recommendations for maintenance action. In addition to the engineer’s free text comments, predefined comments can be added to the report automatically when a parameter is outside specification limits, significantly speeding up sample processing.

Blending Control

The QSI Blending Module allows production departments to optimise a blend, not only in terms of product specification variables – like viscosity, for example – but also in terms of raw material cost, and can then use the laboratory testing data to perform blending corrections if necessary. These corrections can be carried out manually or automatically. At all times the production departments are able to interface directly to the “Optimiser” via their own input screens, to define parameters like batch size and maintain overall control of the process.

Sensory Testing

The sensory functionality will hugely reduce the quantity of paperwork that is often involved in processing sensory results and virtually eliminate the transfer errors and bias that can be introduced when data is communicated verbally. “Data” in sensory testing is not just numerical – “degree of difference” etc.- but can also be panellists’ comments, and both types of information can be collated, interpreted and ultimately reduced to a single result. Parameters are fully flexible and user defined, so it is easy to accommodate company or industry rules and conventions within the interpretation and reporting process.

Stability Trials

Many laboratories test their products to see how they stand up over time when stored in a variety of environmental conditions. This type of testing is routine for within the pharmaceutical, food and beverage industries; however, chemical companies often have the same requirements. The WinLIMS Stability Testing function is used to define testing protocols for both research and standard release products. Pull schedules, inventory reports, schedule adjustments and other useful functions are built into the WinLIMS stability to provide an effective means to manage the most demanding stability testing laboratories