LIMS Integration

Integrating a NanoPhotometer® with a Laboratory Information Management System (LIMS) involves connecting and synchronizing the two systems to streamline data management, improve data integrity, and enhance overall laboratory efficiency. Integrating it with a LIMS can help automate data entry, reduce manual errors, and facilitate data traceability and reporting. In combination with an ERP system integration, the NanoPhotometer® can help to significantly reduce hands-on time/cost while reducing human error when producing the necessary QC documents to fulfill an order using the proprietary NanoPhotometer® REST API PUSH Service.

Eton Bio in San Diego is one of our clients that has integrated the NanoPhotometer® in their QC workflow:

Key Aspects of the NanoPhotometer® LIMS Integration:

Instrument Interface

Data Transfer

Sample Identification

Data Validation & Quality Control

Data Storage

Data Traceability

Reporting

Automation and Workflows

User Authentication & Security

Maintenance & Support

Instrument Interface

Data Transfer

Sample Identification

Data Validation & Quality Control

Data Storage

Data Traceability

Reporting

Automation and Workflows

User Authentication & Security

Maintenance & Support

Key Benefits of the NanoPhotometer® LIMS/ERP Integration

Integrating a NanoPhotometer® with a LIMS significantly improves laboratory efficiency and contributes to cost reduction, making it a valuable addition to laboratories where precise nucleic acid and protein concentration measurements are required. It helps:

Enhance data accuracy
Reduce manual data entry
Improve data traceability
Contribute to overall laboratory efficiency

Eliminate human error while manually copying data
Automatically transfer data into your ERP
Save a significant amount of money

Implen-UV-Vis-Spectrophotometer-Nanophotometer-LIMS-integration-benefits3

Integration of NanoPhotometer® into LIMS
via REST API PUSH Service

ROI Case Study

The following case study will document the ROI (Return of Investment) for a standard lab setup:

Average salary for a lab technician	Number of samples per day	Manual data handling time per sample	Manual data handling time per day	Money spent per day for manual process	Manual data handling time per year	Money spent per year for manual process
$28/hr	500	30 sec	4.2 hours	$117	1092 hours	$30,576

Average salary for a lab technician	Number of samples per day	Manual data handling time per sample	Manual data handling time per day	Money spent per day for manual process	Manual data handling time per year	Money spent per year for manual process
¥58/hr	500	30 sec	4.2 hours	¥244	1092 hours	¥63336

ROI = (30,576 – 14,000)/14,000 * 100

ROI = 118% the first year

* Based on 5 working days a week, 52 weeks a year. Average instrument purchase price: $14,000. A set-up fee for the integration of the instrument will apply!

Implen offers competent support to integrate your NanoPhotometer® instrument into your LIMS setup.
Please submit the following form to allow our team to get in touch with you:

The ALCOA Model

and how the NanoPhotometer® helps to comply 

The ALCOA model is a set of principles and guidelines used in the context of laboratory information management systems (LIMS) to ensure data integrity and compliance with regulatory requirements, including those set forth by the U.S. Food and Drug Administration (FDA – Data Integrity and Compliance With CGMP Guidance for Industry).

ALCOA is an acronym for Attributable, Legible, Contemporaneous, Original, and Accurate. These principles help ensure that data generated and stored in a LIMS are reliable and trustworthy, which is crucial in regulated industries such as pharmaceuticals and biotechnology.

Here’s a breakdown of each component of the ALCOA model and a description of how the NanoPhotometer® with its unique REST API and PUSH Service contributes to each of the individual requirements:

Attributable:

Data should be attributable to a specific source or person responsible for generating, recording, or modifying it. This ensures accountability and traceability.

The NanoPhotometer® either offers direct transfer of data into a LIMS system or provides User Management, Audit Trail and Electronic Signature as part of the CFR21 option available for most models.

Legible:

Data should be clear, readable, and comprehensible. Illegible or unclear data can lead to misinterpretation and errors.

The NanoPhotometer® with its unique graphical user interface and report options in pdf or Excel formats ensures that data are clear, readable, comprehensible and also traceable.

Contemporaneous:

Data should be recorded at the time the activity or observation occurs. It should not be backdated or recorded retrospectively. This ensures that the data accurately reflects the timing of events.

With encrypted result files in the proprietary IDS format (Implen Document Source), built-in time stamps, audit trail and electronic signature every dataset is fully traceable and cannot be altered or amended intentionally or unintentionally once a measurement is taken. Any data calculation applied will be documented within the audit trail.

Original:

Data should be the first record of an observation or result. Any copies or transcriptions should be clearly marked as such and should reference the original data source. Original data is less prone to manipulation or tampering.

Every reading is recorded the moment it happens with date and time as well as the user that was operating the NanoPhotometer® and pushed to a LIMS system without delay. When operating within the CFR21 option for the instrument audit trail and user information are being recorded within the onboard NanoPhotometer® software.

Accurate:

Data should be accurate and free from errors, omissions, or alterations. Any corrections or changes to the data should be documented, explained, and justified. Accuracy is essential for making informed decisions based on the data.

Since data are submitted to the LIMS system in real-time, all alterations are tracked and recorded within the LIMS system. When operating within the CFR21 option for the instrument audit trail and user information are keeping track of all input, changes and allowed modifications within the onboard NanoPhotometer® software.
Implen offers a proprietary IQOQ package, which operators can utilize to prove that the instrument is working according to specifications and is properly calibrated. Even though the NanoPhotometer® is recalibration free it is good and common practice for GxP labs perform an IQOQ on a regular basis.

In the context of the FDA and other regulatory bodies, adherence to the ALCOA principles is critical for maintaining data integrity, ensuring the safety and efficacy of pharmaceutical products, and demonstrating compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).

LIMS systems play a crucial role in supporting these principles by providing a structured and secure environment for data management, storage, and retrieval in laboratories. They help enforce data integrity by providing audit trails, electronic signatures, version control, and other features that align with the ALCOA principles. Additionally, LIMS systems often undergo validation processes to ensure their compliance with regulatory requirements, including those set by the FDA.

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LIMS Integration

Instrument Interface

Data Transfer

Sample Identification

Data Validation and Quality Control

Data Storage

Data Traceability

Reporting

Automation and Workflows

User Authentication and Security

Maintenance and Support