The paramount concern of laboratories within the Pharmaceutical industry is the Safety and Quality of products produced and developed. WinLIMS® provides features that obtain and retain test and sample processing information in accordance with regulatory requirements and manage laboratory workflow in a highly efficient manner.
Meeting Your Pharmaceutical Laboratory Needs
WinLIMS® includes standard features and controls and functionality to meet the rigorous demands of the world’s governments that regulate this business sector. Some of the features that are included within the core and optional WinLIMS® modules that are specifically designed for the pharmaceutical & medical device business sectors include:
- Electronic signatures in conformance with 21 CFR Part 11
- High levels of role-based security
- Training and qualifications option
- Full trigger-based audit trails
- Version controls for methods, specifications and protocols
- A shelf-life stability management system
- Complaints and corrective actions
- etc.
Our Current WinLIMS® Customers
QSI will provide our internal software validation documentation to you and your validation consultants to assist in your system validation process. Some of our current pharmaceutical and health care customers include:
Powerful LIMS Functionality
WinLIMS® provides all of the functionality that is required to run a modern laboratory right ‘out-of-the-box’ so you can start using your WinLIMS® software within hours of installation.
Role-Based Security System
WinLIMS® role-based security system can be integrated with Active Directory to limit users to only the information and functionality that is associated with their role within the laboratory to ensure the integrity of your data.
Version-Controlled Configuration Templates
Product specifications, test methods and other information that is subject to re-versioning is managed within WinLIMS® ensure data accuracy and product quality with a full audit trail of all changes that are made.
Multiple Sample Login Options
Samples can be manually created individually or in batches via PC or handheld device to accommodate the workflow of your operation. Creation of samples can also be initiated via interface to 3rd party applications (e.g., ERP systems) to eliminate duplication of effort and user error.
Sample Tracking & Workflow
Laboratory and product workflow status are automatically assigned by WinLIMS® to guide samples to and through the laboratory. Dashboard web parts allow instant access to this information to efficiently monitor the progress of lab work and your facility’s production process.
Multiple Results Entry Options
A variety of manual and automated results entry screens and tools allow results to be entered into WinLIMS® in a manner that is natural to your work environment. All data entry provides instantaneous feedback that indicates the quality of the product being tested to allow rapid management decisions.
Result, Sample, and Production Review
Multiple levels of peer and management review of individual test, test worklist, sample and product information are provided to ensure that the release of information conforms with your organization’s policies.
Powerful Calculation Capabilities
WinLIMS® includes a powerful calculation engine that allow both simple and complex calculations to be performed based on the entry of raw data. The use of automated and validated calculations simplifies the entry of result while ensuring that all calculations are accurately and consistently performed.
Document & File Integration
Documents that represent product specifications and testing methods can be attached to their associated WinLIMS® records to provide instant access during the testing process. In addition, WinLIMS® includes a full document management system that can be used to manage all of your organization’s documents in a controlled manner.
Instrument Calibration & Maintenance
WinLIMS® includes an instrument/equipment management module that inventories all instruments to automatically schedule maintenance. In addition, all calibration and control information are captured and provides on-going statistical information to ensure the integrity of data that is obtained.
Online SQC/SPC Charting
Statistical evaluation of data using the Western Electric rules is immediately available at the time of results entry that allows process information to be evaluated to avoid production problems. On-line SQC charts can be issued with the click of a button to efficiently monitor historical information.
Integrated Reporting
An unlimited number of site-specific reports can be issued by passing information from any page or query to the report by the click of a single button. Reports can be saved in a variety of formats (e.g., PDF, Excel, Word, etc.) to simplify the sharing of information to consumers and allows them to receive the data in the format that is germane to their needs.
Shelf Life Testing
The WinLIMS® Shelf Life module allows the definition of testing protocols and manages pull schedules, labels, inventory reports, schedule adjustments, reports and other functions to provide an effective means of efficiently managing the demands of Shelf Life testing.
Inherently Multi-Lingual
WinLIMS® menus and pages are inherently multi-lingual. This allows users within multi-national laboratories to see the menus, pages, messages, etc. in local language for more comfortable use. In addition, the software automatically offsets time zone differences and presents dates and numbers based on the culture of the local country adding to the ease of use.
Integrated Audit Trail
Modifications made to all data is recorded within the WinLIMS® audit trail which is essential for organizations that serve regulated industries. The audit trail also allows you to investigate issues that arise when data is erroneously modified.
Barcode Labeling and Tracking
Barcodes can be generated by WinLIMS® within reports and labels and used to positively identify samples via barcode scanner. Barcoding is most frequently used to confirm receipt of samples, transfer samples from department-to-department, load samples into autosampler trays, and retrieve information on the WinLIMS® pages.
Microbiology Testing
WinLIMS® allows you to record the equipment and reagents that are used in conjunction with micro testing and schedules the incubation times to simplify workflow. The scheduling provides read time notifications while serial dilution calculations ensure that the correct information is recorded and reported.
