QuaLIS LIMS suite is a best LIMS software that encompasses a range of integrated solutions, designed from ground up for any kind of laboratory across multiple industries or domains like pharmaceutical, chemical, environmental, food & beverage, dairy, contract research, clinical research, diagnostic pathology, public health. The software addresses regulatory compliance requirements for laboratories that practice or need to comply with Good Laboratory Practice like (GLP), 21 CFR Part 11, Eudralex Annex 11, GCP, cGMP, ISO 17025, Netcord, Nelap etc.
QuaLIS LIMS is a COTS product with all key Laboratory required functionality that can be deployed on a web server and natively supports open source OS and Databases. It is a Comprehensive LIMS for QC/QA and Analytical R&D. The solution supports multi-sites and multi-sections and caters to the automation needs of any laboratory. This automated solution is a complete specifications management that manages the end-to-end process of QA/QC department in laboratories to comply with GMP/GLP requirements. Easy to accommodate new requirements, to solution allows extending user interface, business logic and database model without programming (using QuaLIS Studio). The solution is 100% Web based, Reliable and Proven architecture built on Java platform and can be deployed on a variety of hardware and software platforms including open source. The compelling features of QuaLIS LIMS include:
- Test and Specification Management: Test Masters with relevant attributes and parameters can be maintained based on test category and specific sections within the laboratory that will perform the tests. Specifications can be managed for multiple materials with several layers of hierarchy for quick access and easy maintenance.
- Sample Registration & Test Ordering: Samples (Raw Material, In-Process and Finished Product) received are pre-registered with a unique sample number or an Analytical Request number (AR Number) along with Batch#, Lot# and routed to respective testing sections for further processing steps. It is possible to perform complete specification based testing by selecting the appropriate profile and specification (USP, BP, IP) for each sample. Testing priorities can also be set for samples.
- Barcode Labeling: QuaLIS supports barcode label generation. Labels will be generated after completion of sample registration. Barcode labels can be used to quickly identify result records, jobs etc. within the application and chain of custody can be easily recorded.• Job Allocation: Job Allocation module enables allocation of tests, instruments and personnel for samples. Authorized user/supervisor can allocate available and qualified analyst to perform a specific test. More than one analyst can be allocated per test with split job responsibilities.
- Manual or Instrument Data Capture: It is possible to manually enter data in the electronic test data sheets while calculations are performed in real-time. It is also possible to interface any analytical instrument with the electronic test data sheets.
- Result Entry, Raw Data, Traceability: Results entry module allows analysts to enter test results based on a sample number and test. Final results along with instrument used with its identifier, usage time, calibration status while test execution can be linked.
- Approval: QuaLIS approval workflow steps can be configured to achieve multiple levels of approvals and actions to be performed on approval actions. First level of approval post result entry is verified by a personnel who can check individual test results, calculations performed, raw data captured etc. Once verified the sample is marked as verified. The verifier can reject the results and request a re-test/re-calculation.
- Reports: QuaLIS includes a dedicated reporting module and is pre-packaged with a set of commonly used reports. Reports can be easily configured to specific user requirements. Reporting module provides users with an easy to use interface to generate reports, lookup previously generated reports based on specific criteria.
- Material Inventory Management: The complete material inventory of the laboratory can be managed using this module. A material category master helps in creating masters for all types of standards (reference standards, working standards, and third party material standards), volumetric solutions, reagents, chemicals, glassware, etc. along with the details.
- Instrument & Equipment Management: Maintenance of all instruments and equipment across the lab can be managed under this module. Calibration and maintenance of instruments can be managed under this module. The scheduler sends alerts and can generate calibration samples automatically. The status of each instrument can be maintained.
- Document Management: Various categories of documents can be maintained with versioning and release capabilities. Documents can be uploaded, categorized with version control, description & unique ID with release workflow and controlled access.