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
Instrument Interface
The first step in integration is establishing a communication link between the NanoPhotometer® and the LIMS. This often involves connecting the instrument to the laboratory network or directly to a computer where the LIMS is installed.
Data Transfer
Data Transfer
Integration enables the automatic transfer of data from the NanoPhotometer® to the LIMS. This includes measurement results, sample information, and any relevant metadata.
The NanoPhotometer® offers 3 levels of integration:
Automatic upload of pdf and/or Excel files to a server drive within the LIMS system
Transfer of specific data produced by the NanoPhotometer® either to a form or a template within the LIMS system the proprietary NanoPhotometer® REST API PUSH Service. Data are being acquired on the instrument using either the onboard software or computer app. The result data are automatically pushed to LIMS after each reading
Execution of a method directly from LIMS and an automatic population of the measurement template with the obtained results coming from the instrument
Sample Identification
Sample Identification
The LIMS can provide sample IDs and associated information to the NanoPhotometer®. When a sample is loaded into the NanoPhotometer®, it can automatically associate the measurements with the correct sample ID, reducing the risk of data mix-ups utilizing the NanoPhotometer® IP address within the network.
Data Validation & Quality Control
Data Validation and Quality Control
The LIMS can implement data validation rules and quality control checks to ensure that the measurements from the NanoPhotometer® meet specific criteria before being accepted and recorded in the LIMS.
Data Storage
Data Storage
All data generated by the NanoPhotometer®, including absorbance readings and concentration calculations, will be securely stored within the LIMS. This ensures data integrity, accessibility, and long-term archiving.
Data Traceability
Data Traceability
Integration ensures that every data point generated by the NanoPhotometer® is traceable back to the instrument, the operator, the date and time of the measurement, and the specific sample or assay being analyzed. This traceability is crucial for regulatory compliance and auditing purposes.
Reporting
Reporting
The LIMS can generate customized reports based on the data collected from the NanoPhotometer®. These reports can be in various formats, including PDF, Excel, or custom templates, and can be easily shared with relevant stakeholders. In addition, the NanoPhotometer® also provides the option to produce pdf and Excel reports directly from the instrument.
Automation and Workflows
Automation and Workflows
Integration allows for the automation of laboratory workflows. For example, the LIMS can trigger additional assays or experiments based on the results obtained from the NanoPhotometer®.
User Authentication & Security
User Authentication and Security
Proper user authentication and security measures should be in place to control access to both the NanoPhotometer® and the LIMS, ensuring that only authorized personnel can operate the instrument or access the data.
Maintenance & Support
Maintenance and Support
Regular maintenance and support for the integrated system are essential to ensure its continued functionality and compliance with changing requirements and regulations. Even though the NanoPhotometer® instruments do not require maintenance or recalibration for a lifetime, it is good practice to run an IQOQ procedure on a regular basis. Implen is offering IQOQ either as a stand-alone option or as part of the CFR21 software package.
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
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 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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