Standard WinLIMS.NET Features
WinLIMS.NET™ Forms client version 7.0 is the client/server version of QSI's 7th generation software of WinLIMS software in the client / server variant. This section briefly describes the Standard WinLIMS Features that are included within all WinLIMS.NET™ systems right "Out-Of-The-Box" whether web-based or traditional client/server-based. This page also provides a brief description of the optional modules that are designed for the needs of specific industries.
- 1 Basic WinLIMS Features
- 1.1 Methods Development
- 1.2 Specifications Management
- 1.3 Single Sample Login
- 1.4 Batch Sample Login
- 1.5 Request Login
- 1.6 Automatic Sample Scheduling
- 1.7 Barcode Label Printing
- 1.8 Sample Receipt
- 1.9 Barcode Sample Receipt
- 1.10 Work Allocation
- 1.11 Worksheet Production
- 1.12 Results Entry By Sample
- 1.13 Results Entry By Method
- 1.14 Results Entry By Crosstab
- 1.15 Results Entry By Excel
- 1.16 Results Validation
- 1.17 Sample Approval
- 1.18 Batch Approval
- 1.19 Statistical Graphing
- 1.20 Sample and Batch Certification
- 1.21 Project Management
- 1.22 Supplier & Customer Records
- 1.23 Automatic Email
- 1.24 LIMS Event Triggers & Actions
- 1.25 Confirmatory Testing
- 1.26 Security & User Privileges
- 2 Optional Modules
- 2.1 Customer Specification Matching
- 2.2 Product Regrade
- 2.3 Stability Trials
- 2.4 Electronic Signature
- 2.5 Results Entry By Batch
- 2.6 QA/QC Batch Processing
- 2.7 Results Entry By Instrument Acquisition
- 2.8 Instrument Calibration & Control
- 2.9 Materials Stock Control
- 2.10 Training & Qualifications
- 2.11 Quotations & Invoicing
- 2.12 Formulations & Recipe Control
- 2.13 Complaints & Corrective Actions
- 2.14 Automatic Batch and Sample Login Via MRP/ERP Integration
- 3 Citrix & WinLIMS Forms Client Software
Basic WinLIMS Features
Standard WinLIMS.NET™ provides all of the features listed below. Each of them can be configured to accommodate local needs, workflow and nomenclature to ensure quick acceptance by your staff and provide quick payback on your investment.
Method development permits you to create "templates" for each of your laboratory testing methodologies. When defining a template, just enter the appropriate descriptive information to recate a complete, well structured format that ensures proper testing and informative reporting. The following are some of the details that can be associated with each test method template.
- Result parameters (analyte, characteristic, etc.)
- Instrument (if any) used to perform the analysis
- Test Method Detection limits (not to be confused with product specifications)
- Calculations used (simple or complex)
- Sample preparation method
- Testing sequence (Standards, Controls, Spikes, Duplicates, etc.)
- Resource management information associated with the method
- Cross reference to SOP documents and other informative files
- and more...
Methods records are fully version controlled to accommodate GLP/FDA guidelines.
In most laboratories methods are assigned to samples based on the type of sample submitted. Specification management allows you to define "tests suite templates" that define the test methods and limits that are associated with the samples when the specification is applied to the sample. Multiple product specification limit levels and statistical quality control (SQC) rules can be applied to each parameter (analyte/characteristic). During results entry WinLIMS compares the entered results to the limits and issues warnings and assigns status values whenever they are violated.
Specifications can be created for a variety of sample types, including:
- Raw Materials
- Finished Products
- Environmental Samples
- Research and Development
- and more…
Specifications are fully version controlled to ensure that historical accuracy is maintained for all of the products that you produce.
Single sample login enables users to register a single sample within a web page. The registration process allows the user to identify a sample using your site-specific naming convention and automatically assign tests and their product-specific limits (if desired) using simple point and click operation and by applying your company's business logic.
Provides a means for registering multiple samples that are associated with the same production batch (or lot) within a single web page. This is a convenient tool that provides fast sample registration, data editing, results entry and data review in high volume environments.
This tool is designed for use within analytical service and research laboratories where Requests (Jobs, Submissions, Incidents, etc.) are submitted that include one or more samples and need to be organized within a related data set. Requests can also be associated with Projects to incorporate a structure that makes data review and reporting both logical and efficient.
Within many laboratories samples are taken from production and/or environmental monitoring sites on a routine basis that is based on a time schedule. The WinLIMS automatic sample scheduler provides a simple table entry tool that allows you to identify the sample(s) to be taken, the time period, the time basis (minutes, hours, days, weeks, months or years) along with other descriptors. When the appropriate time is reached, the sample record is created and is assigned the workflow status of "Logged Pending Receipt". Labels and/or worksheets can be printed and the pick-up can be made available to web-enabled devices (such as iPhones) or downloaded to standalone devices to provide an accurate and dynamic pick-up list for in-plant or off-site samplers.
Barcode labels can be printed automatically upon sample login, sample receipt or on-demand. The labels can include any of the sample's descriptors and can contain both human and machine readible (e.g. barcode) fonts. Logic can be built into WinLIMS to print the appropriate number and style of lables to accommodate "splitting" samples on the basis of your distribution requirements (e.g. by lab, by test, by storage conditions, etc.).
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. By recording the time/date and user at the time of receipt WinLIMS can calculate laboratory turnaround times within management reports.
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.
Although WinLIMS can automatically assign work to labs or individual users and to instruments, it is possible that that the work will need to be re-assigned (or re-allocated) to a different lab, staff memeber and/or instrument. The Work Allocation function provides a quick and easy way to reassign work accordingly. Once the work is assigned, worksheets can be generated.
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.
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.
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 within on page. Results Entry by Crosstab 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.
Results Entry By Excel
The Results Entry by Excel function can be used as a replacement for the Results Entry by Crosstab function or within labs where Excel is the tool of choice for results entry. This function allows you to select a sample or sample set and then generate a pre-formatted Excel spreadsheet that can be used for direct results entry into WinLIMS upon saving the spreadsheet. You can also take the spreadsheet "off-line" to conveniently enter results when disconnected to the network (or internet) while performing plant or field testing. Upon reconnection to the network, the results are automatically uploaded into WinLIMS using a Windows Service.
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 laboratories. WinLIMS provides this level of review and audit trail recording in a security-restricted manner.
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.
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.
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.
Statistical graphing is available within WinLIMS. For example when reviewing a sample the user can highlight a result parameter and click the SQC button and the results for the measured parameters (analytes/characteristic) will be presented within a graphical display to quickly identify trends. The display also presents the statistical information (mean, standard deviation, control limits, Cp, CpK values, etc.) that is commonnly used by most laboratories. The system also displays any violations of the 8 "Western Electric" rules.
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.
WinLIMS enables the creation and control of projects. The project information can contain the following information.·
- Project Number
- Project Name
- Project Description
- Project Leader
- Project Team
Once a project has been defined within WinLIMS samples or batches can be associated with a project in order to provide consolidated results and performance reports (e.g. costing and accounting).
Supplier & Customer Records
The WinLIMS address manager enables the creation of contact information for any individuals or companies that interface with the laboratory.
The following are the contact categories that can be recorded.
- Subsidiary Companies
- Sample Submitters
These contact records are then made available throughout the other WinLIMS applications to avoid addition data input, such as sample and batch login.
Allows status changes within WinLIMS™ to automatically generate customer specific actions such as, creation of C of A's and "out of spec" reporting, via external E-Mail systems.
LIMS Event Triggers & Actions
WinLIMS allows the users to define specific events and what actions are required when the event is triggered. Typically events are sample or batch status related, for example, a sample being out of specification could be the event trigger and the action an email notification to selected people.
The following are typical actions.
- Automatic email notification
- Running a report
- Executing a database procedure
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.
Security & 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.
The security system is multi-layered.
- Layer 1: Underlying Database Access – Mandatory
- Layer 2: WinLIMS Application Access – Mandatory
- Layer 3: Site-Specific Access – Optional
- Layer 4: Training-Specific Access – Optional
Industry specific modules can be added to WinLIMS that are integrated with the basic WinLIMS.NET functionality and also operation "Out-Of-The-Box". These are offered as options in order to ensure that you purchase only those functions that you need to automate your lab and, thus, purchase the software for the highest rate of return on your investment.
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 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.
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.
The Electronic Signature option provides a configurable tool that enables each lab to configure which events require an electronic verification of specific record creation, update and/or approval. The electronic verification can take the form of the re-entry of the user's password, a secondary password or a biometric reader. The electronic signature option ensures compliance to CFR 21 Part 11.
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.
The WinLIMS QA/QC option enables users to set up templates for automatic insertion and recording of quality control items such as blanks, spikes, duplicates and standards.
Results Entry 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.
WinLIMS provides integrated functions, which allow users to define and closely monitor each of the instruments that are used for analysing samples. 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.
Materials 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.
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.
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 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
Formulations & 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 component list and quantities for each component. This formulation information is then available for other WinLIMS functions such as blend corrections or recipe pre-weigh.
The WinLIMS™ Complaint and Corrective Action Option provides additional database tables, functions and reports that are used to log complaints from customers or to file problems associated with the production of products. Once logged, corrective actions, which have been implemented to resolve the complaint or problem, may be logged until the problem has been resolved.
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.
Citrix & WinLIMS Forms Client Software
Several QSI customers who run the Forms Client (traditional EXE application) WinLIMS software in a Citrix environment and no special software setup is required. Simply install WinLIMS on a Citrix server as though it were being installed on a single user PC. As a point of clarification, configuration of Citrix software/hardware is not part of WinLIMS support; you are required to be well-versed in its operation. If you are interested in pursuing Citrix, QSI can put you in contact with existing customers who can assist you on how and why they use WinLIMS with Citrix.
In terms of licensing, your WinLIMS license agreement allows you to have a specific number of concurrent users; that would not change if you use Citrix. As always, you are free to install WinLIMS on as many client PC's or Citrix terminals as you wish so long as you do not exceed the number of concurrent WinLIMS licenses.