Power Your Environmental Lab with a LIMS Built for TNI Success

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Many laboratories choose, or are required to, be certified to the standards of the NELAC Institute’s (TNI) NELAP regulatory compliance. TNI standards are modeled after ISO 17025, with a deeper focus on requirements specific to environmental laboratories. Compliance with either standard gives organizations a competitive advantage by demonstrating their commitment to maintaining an accredited Quality Management System (QMS). Accreditation also provides internal and external customers with assurances regarding the quality, reliability and reproducibility of testing data.  

Leveraging Confience eLIMS for Achieving and Maintaining TNI Compliance:

Laboratory Information Managements Systems (LIMS) are an essential part of achieving and maintaining these accreditations and can provide the backbone to any laboratory’s QMS.  

TNI requirements specify that laboratories must prevent changes to analysis data and enable the reproduction of original results by linking data and outcomes. Traceability and a complete, secure audit trail are key. Additionally, laboratories must be able to retrieve stored data for a specified number of years.  

Confience eLIMS is state-of-the-art LIMS software that automates the process of ensuring data integrity by limiting access to data to authorized users, preventing users from entering results without adequate training, and tracking changes to defined data fields, including results, ensuring both security and compliance.

Samples follow a pre-defined workflow process, and Confience eLIMS produces compliant electronic records for each step, linking all related information together to create a comprehensive traceability matrix.  

Confience eLIMS streamlines sample tracking from start to finish—login to disposal—capturing every critical step needed for reliable, defensible results, and securely documenting the entire sample lifecycle.

Version-Controlled Configuration Templates:

A variety of interactive templates are used within Confience eLIMS to define testing procedures, product specifications, protocols, and instruments, making workflows as efficient as possible. These templates can change over time, so the LIMS provides a version control and audit trail system to ensure adherence to TNI standards.

Training Record Management:

TNI standards mandate participation in proficiency testing (PTs), demonstration of capabilities (DOCs) and regular staff training. The Confience eLIMS Training and Qualification module tracks the schedules and results of proficiency testing, aiding laboratories in demonstrating competency in performing specific tests. Moreover, the LIMS maintains records of staff training and certifications, ensuring analysts are granted the ability to enter results for only those testing procedures on which they have successfully trained.

Comprehensive Audit Trail:

Confience eLIMS features full audit trail capabilities for all data. It prevents deletion of data, once recorded, and the documents all defined modifications to samples, tests, analytes, inventory, results, etc.  

Audit trails can be applied to any of the tables within Confience eLIMS and will record each change that is made to any or all records in the system on a field-by-field basis, as defined by the LIMS Administrator. The audit trail records what was changed, when the change was made, who made the change, why it was changed, wherever it is practical to do so, and the previous value. The audit trail ensures data integrity is maintained, and supports defensible results, ensuring compliance with TNI.

Chain-of-Custody (COC):

The Confience eLIMS COC feature tracks the physical movement of samples with date/time stamps. Users can also attach an unlimited number of images, documents, spreadsheets, etc. This robust COC is a critical aspect in meeting TNI standards, which place a strong emphasis on the traceability and accountability of every sample.

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Clicking the “Chain Link” will provide access to all associated COC information.

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Additionally, COC Reports may be generated for use in the field, or away from the laboratory bench.

Electronic Signatures:

Confience eLIMS uses electronic signatures to meet TNI data integrity standards and comply with regulations like FDA regulation 21 CFR Part 11, ensuring electronic records and signatures are reliable.

The Confience eLIMS Electronic Signature module provides additional password prompted functionality for the validation, approval, and certification of data. These signed electronic records contain the name of the signer, the date and time the signature was executed and the purpose of the signature.

Sample Scheduling:

The Confience eLIMS Auto Sample Scheduler allows users to easily create sampling schedules for the short or long term to eliminate errors and conserve valuable time. Users simply define records that contain the scheduling information such as the frequency of testing (minutes, hours, days, weeks, months, etc.), start and end date/time and associated comments. When the next scheduled time arrives, a fully identified sample is automatically logged into the LIMS and all the appropriate tests are assigned.

Labels, worksheets and/or pickup schedules (with barcodes) can be automatically printed in the lab or in the plant to simplify the collection and identification process. The receipt of the sample can be recorded within the LIMS to automate COC information and enable users to quickly identify when physical samples were missed.  

This is an ideal tool for scheduling environmental monitoring samples, routine calibration samples, management reports, etc. Scheduling frequencies can be simple (e.g. once every ‘x’ hours, once a day, once a week, etc.) or complex (e.g. the 2nd Tuesday of each quarter), so even the most complex scheduling rules can be accommodated.

Calculations:

Confience eLIMS automates, verifies, and validates calculations, removing the need for manual effort. Automated calculations accelerate workflows, increasing throughput and efficiency. Quality Assurance and Quality Control features include automated calculations of mean, standard deviation and control limits. Users can generate various types of charts including control charts, view trends, and compare analysts for workload and data quality.  

Virtually all mathematical functions are supported, including Boolean algebra. Functions such as [IF], [THEN] etc., especially useful. The LIMS exceptional flexibility allows calculation routines that can use numeric values from anywhere within the 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.

In addition, the calculations can initiate stored procedures that can execute business rules such as the automatic registration of samples, updating records in the ERP system or any other logically derived function to ensure the smooth processing of information within the organization.

Instrument Maintenance, Calibration and Repair Logs:‍

TNI requires organizations to ensure instruments and equipment are calibrated, validated and maintained properly.  

Confience eLIMS can integrate with laboratory instruments, reducing manual errors, minimizing turnaround time and allowing for accurate data reporting to regulatory bodies. The LIMS system provides an integrated function which allows users to define and closely monitor each of the instruments that are used for analyzing samples. This 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. Instruments and equipment can be marked as unavailable when maintenance or calibration is due. This prevents tests from being assigned to them.  

‍Complaints and Corrective Actions (CAPAs):

It is imperative for laboratories to document any non-conforming work and develop preventative or corrective action plans (CAPAs) to minimize the risk of recurrence. With the Confience eLIMS Complaint and Corrective Action module, a CAPA can be assigned to a customer/vendor or contact, and associated with a sample, request/lot#, batch, product, or parameter or another item. Supporting documentation may also be attached to facilitate the CAPA process.  

With this functionality, Confience eLIMS allows laboratories to create and track the activities involved with the initiation, investigation and resolution of these items, and to monitor the effectiveness of the actions and/or identify any similar issues in the future. These records are then retained as evidence.

Integrated Reporting:‍

Confience eLIMS prepares laboratories for audits by providing the tools to easily generate comprehensive reports and logs of all laboratory activities. These reports can include details of sample custody, analysis timelines, QC activities, and corrective actions taken in response to non-conformances. The availability of this information simplifies the audit process and helps demonstrate compliance with TNI standards in a transparent and efficient manner.

Crystal Reports is used to access, format, and deliver data that is created, managed and maintained within the LIMS database or from a variety of other data sources such as SQL Server, Oracle, MS Access, etc. Reports are accessed from a security-restricted web page that is organized into "folders" defined by appropriately permissioned users to accommodate the organizational structure.

Reports are registered within Crystal Reports where they are associated with specific Confience LIMS pages. When run in this manner the current record (or record set) can be passed to the report to make effective use of the powerful query tools that are available within the LIMS, which greatly minimizes the number of report designs. Reports can be printed to hardcopy, saved as a file in a number of formats (e.g. PDF, DOC, XLS, TXT, etc.) or emailed directly to the desired recipients. To add even more efficiency, reports can be automatically sent to email recipients using the integrated LIMS Events function.

Quality Management:

The Confience eLIMS Quality Management functionality helps laboratories maintain data integrity in the results produced. Functionality includes:

• Automatic insertion of calibration & quality samples  

• Association of results with the instrument used to acquire results  

• Automatic creation of instrument statistical histories  

• The ability to include spike and duplicates (and calculate recoveries)  

• The order sequence of each ‘analytical batch’ of samples  

• The ability to review ‘analytical batches’ of samples in context and validate in ‘brackets’

• Traceability of all results based on user, instrument, date, time, sample preparation reagents, instrument calibration and control standards, etc.
  

Inventory Management & Sample Prep:‍

The Confience eLIMS Inventory Management & Sample Prep module provides a repository for all your laboratory chemicals and supplies and provides the means of providing inventory control as materials are received and consumed within the laboratory. The Sample Prep feature associates each sample with the reagent (lot number, amount, etc.) that was used to prepare the sample.

When used in conjunction with the powerful Confience eLIMS Events feature, staff members can be notified when materials fall below reorder levels and when chemicals and reagents exceed their expiration dates. Via the Confience Bridge, Confience eLIMS can be expanded to interface with your purchasing system should you desire to automate the entire management process.

The Confience eLIMS Material Inventory function displays the individual shipments that have been received. The records will include key information such as the supplier, lot number, amount received, current amount on-hand as well as the expiration dates of each. It manages the overall quantity of the material that is on-hand by incrementing the value as new shipments of the material are received and decrementing the materials as they are used by the organization. Users with proper permissions can also define a reorder quantity which can be used to issue notifications to the appropriate staff members whenever the current quantity of material on-hand falls below the reorder quantity.

Conclusion:

The integration of a laboratory data management system in environmental laboratories provides a robust framework for adhering to TNI standards. By automating key processes, ensuring data integrity, and facilitating audit preparations, Confience eLIMS not only supports compliance but also enhances the overall efficiency and reliability of laboratory operations. As environmental standards continue to evolve, investing in a LIMS is a strategic move for laboratories aiming to maintain accreditation and excel in their field.