Main LIMS functionalities and modules
- Sample/batch management and results, including review and approval cycle and development of Certificates of Analysis or test reports
- Management of specifications and test methods
- Management of stability studies
- Equipment/instrument management and calibration
- Reference standards/materials management
- Environmental and utility monitoring
- Support for bar and QR codes
- Managerial reporting and overviews
- Equipment and ERP systems connection (under development)
Management of samples and results
The basic process in the laboratory is the management of samples and results. The process begins with the receipt of a sample in the laboratory, continues with its registration and the assignment of test specifications, the testing and recording of results, automatic evaluation of results against specifications, review and approval of results, approval of the sample. Finally, it includes creation and printing of the Certificate of Analysis or Test Reports, and/or release of the corresponding batch for further use.
F4 Result review and approval
Review and Approval of results by a second person
F5 Sample approval
Sample approval, confirming that the prescribed tests were completed, results entered and approved, electronically signed, if required
F6 Reporting (CoA, Test report))
Reporting of results to the customer, by means of a Certificate of Analysis, or a Test report
F1 Sample receipt
Receipt of the sample in the laboratory – the sample is delivered from a customer, internal production, or warehouse
F2 Sample logging
Sample logging in LIMS, typically including Sample name, Customer name, Due date, Specification, etc.
F3 Testing and results entry
Execution of pre-defined tests according to Specification and Results entry. Automatic evaluation of results against specification
Other modules and functionalities:
Methods, Equipment, Reference standards and other modules
Sample management and results can be directly related to test methods, equipment, reference standards, chemicals, chromatographic columns, solutions, and auxiliary materials. The system offers additional functionalities such as sampling records, re-testing, evaluation according to multiple customer specifications, and maintenance and evaluation of stability studies.
Workflows and user Roles
Samples can be managed individually by sample type and processed according to a specific configurable workflow, e.g. QC workflow, ISO17025 workflow, R&D workflow, etc., using specific user roles, privileges, and the approval panels. The modules are configurable as well, i.e. the fields/entries and the print reports in multiple languages.
Configuration and task and timelines monitoring
The same principles of configuration and workflow options apply to the recording and approval of stability studies, test methods, equipment and calibrations, reference standards, solutions, columns, chemicals, and consumables. Automatic monitoring of tasks and time completion to ensure the validity of equipment calibrations, the validity of reference standards, solutions, etc., can be done either graphically – by using a traffic light system, or through email notifications, reminders, and escalations.
Audit trail and History of records
An Audit trail and History are maintained for all desired records. The Audit trail review is facilitated with filters, facilitating finding the required information and signing off the history fast, if required. All operations and records are 100% traceable. Records cannot be deleted, altered, or falsified. They can only be moved into a trash bin in a controlled manner, and reviewed/restored if required.
General functionalities
In all LIMS modules, users can use general functions like filtering, full-text search, export and import, attachments (PDF, docx, xlsx, jpg, png, etc.), links to related records, and use managerial tools to generate reports or run SQL queries through the LIMS database.
LIMS and DMS/QMS connection
LIMS modules can be connected with DMS, QMS, and SDE (Statistical Data Evaluation), all in one single validated environment, without the need for interfaces with other systems. The management and maintenance of all records and processes in one single system speeds up the laboratory operation and approval processes, eliminates the need for multiple user login between applications and meets the data integrity requirements.
Currently, we are developing the connection of LIMS to various laboratory equipment and ERP systems with the ability to extract, store and data-mine large volumes of primary data.
Examples EffiChem 5.0 LIMS
Sample and Results detail
The sample detail shows descriptive data like the sample name, the batch number, receipt date, storage conditions, customer, etc. The Results table gives a list of parameters to be tested, corresponding units, required specification, the measured value and reported values, evaluation against the specification, the required and the calculated RSD, recorded by, checked by, and other configurable data fields.
Sample and Results detail
The sample detail shows descriptive data like the sample name, the batch number, receipt date, storage conditions, customer, etc. The Results table gives a list of parameters to be tested, corresponding units, required specification, the measured value and reported values, evaluation against the specification, the required and the calculated RSD, recorded by, checked by, and other configurable data fields.
Equipment
The Equipment module shows the equipment-related data, such as description, name, equipment type, equipment classification, inventory number, manufacturing number, etc. The module enables to manage and monitor the equipment calibrations, incl. expiry date, and other equipment-related actions, like delivery, installation, qualification, etc., and record the entire equipment history at one place.
Reference standards
The Equipment module enables to register reference standards, incl. their name, batch number, purity, manufacturer/supplier and other related data, such as receipt date, storage conditions, CoA, etc. Besides, it can be used to monitor and manage the stock, the expiry date, and have the entire reference standard history at one place.
Columns
The Columns module is used to register chromatographic columns, incl. their name, column type, manufacturer, serial number, stationary phase, and other data. The module enables to create and manage the column usage history, helping to trace back who used it, for what, the mobile phase, the theoretical plate numbers obtained, etc..
Dashboard
The desktop is a cross-road from which individual functional modules can be started, including Samples and Results, Controlled documents, Equipment, Reference Materials, Deviations, Changes, CAPA, Statistical data evaluation, etc. The desktop can be individually configured per user for maximum efficiency.
Products
Solutions offered
Important links
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