A Boon for Inspectors and Examiners: The Digital Leap from Manual Transcription to One-Click Association
Digital and Intelligent Management of Inspection and Testing by SunwayWorld
With the in-depth penetration of internet technology, the informatization of laboratory management has evolved from a single function to multi-dimensional collaboration. Promoting the transformation of the inspection and testing business model through informatization means, and realizing the electronic and digital management of original records, is the core direction to improve the quality and efficiency of laboratories. Against the backdrop of the widespread application of Laboratory Information Management Systems (LIMS), paperless office has become an inevitable choice for the development of the industry.
I. Current Status of Laboratory Informatization in the Inspection and Testing Industry
Laboratory Information Management Systems have been commonly applied in inspection and testing laboratories. However, due to the complexity of original records in such laboratories, including a large number of non-standard methods and unstructured data, paper records still dominate the original record management at present.
Although LIMS has been popularized in inspection and testing laboratories, paper records remain the mainstream due to the complexity of original records (e.g., a high proportion of non-standard methods and unstructured data), with the following key pain points:
1. Limitations of Paper Record Archiving
-Risk of data inaccuracy**: The complexity of inspection businesses and large data volume make manual transcription or entry prone to errors in key information such as numbers and decimal points, which directly affects the reliability of test results.
-Low process efficiency**: The compilation, proofreading and review of paper records rely on manual circulation without the support of informatization tools, resulting in insufficient timeliness of review.
-High management costs**: Paper record storage occupies a large space and incurs high costs; retrieval is difficult after archiving, failing to meet the demand for quick search.
2. Drawbacks of Manual Data Processing
Original laboratory records need to cover inspection methods, judgment criteria, experimental environment (temperature and humidity), instrument parameters, sample information, raw data, anomaly explanations, test results and personnel signatures, etc. The manual maintenance of such information not only involves a huge workload but also is likely to cause data deviations due to operational errors.
3. Inadequate Data Utilization Capability
Traditional paper records or scattered Excel files have not formed a standardized electronic data archiving mechanism, leading to difficulties in integrating and analyzing historical data and failing to provide data support for business optimization.
II. Necessity of Paperless Original Records
The inherent defects of paper records restrict the improvement of laboratory informatization level. According to Clause 7.11.2 of CNAS-CL01-G001:2018, informatization systems can be applied to the management of technical records and quality records, and have the same effect as paper records.
However, the data entry methods of traditional LIMS (such as list-based entry) conflict with the working habits of inspectors. In contrast, paper record books feature flexible operation, no need for training and free formatting, resulting in strong user path dependence on the existing working mode. To this end, it is necessary to deeply integrate Electronic Lab Notebooks (ELN) with LIMS in accordance with ISO/IEC 17025, CNAS, CMA and other specifications to solve the above problems.
1. Demand for Improving Informatization Efficiency
Paperless office enables the one-click association and import of information such as personnel, equipment, methods, environment and samples, reducing the time for manual verification and significantly improving work efficiency.
2. Requirements for Compliance and Traceability
Paperless record management takes data authenticity and traceability as the core:
-Task and sample information**: Sample numbers, testing standards, projects and other information are directly associated, supporting real-time synchronization of task changes; basic sample information (name, specification, status, etc.) can be imported with one click to ensure accuracy.
-Environment and resource verification**: Temperature and humidity data are automatically collected and their validity is judged; personnel qualifications and equipment calibration status are verified online to ensure resource compliance.
3. Demand for Structured and Intelligent Analysis
With the growth of sample volume and the upgrading of customer demands, it is necessary to realize big data analysis through the structuring of original records, provide customers with multi-dimensional value-added services and enhance customer stickiness.
III. Paperless Solution for Original Records
Electronic Lab Notebook (ELN) integrates the flexibility of paper record books with the data management capability of informatization systems, and can meet the requirements of regulatory compliance, technical specifications and scientific record-keeping. Its core functions include experimental design, data recording, template configuration, archiving, report export, visual analysis, workflow collaboration and electronic signature, etc. Its main features are as follows:
1. Flexible and Convenient Template Design
It supports structured data storage and custom template configuration, and realizes WYSIWYG (What You See Is What You Get) through an Excel-like designer. Laboratory personnel can directly convert existing Excel files into ELN templates without coding, and it supports formula reuse and format customization, lowering the application threshold.
2. Full-Process Traceability and SOP Compliance
-Process standardization**: Electronic records map the entire SOP process, ensuring that key information (materials, personnel, instruments, calculations, etc.) is recorded for each operation in line with specification requirements.
-Data verification and audit trail**: It supports custom data verification rules and sends real-time reminders for invalid data; it automatically records modification traces and supports electronic signatures, meeting the traceability requirements of ISO/IEC 17025, CNAS, CMA and other standards.
3. Instrument and Equipment Integration Capability
It has a built-in Data Collection Unit (DCU), which supports the automatic collection of instrument data through device workstation files, direct connection ports (RS232/485, RJ45, etc.), database docking and protocol docking, reducing manual intervention.
4. Mobile Application Support
For scenarios without instrument output, it supports online/offline entry via mobile APP, compatible with multiple terminals and browsers, meeting the CNAS specifications for original records and realizing paperless office in all scenarios.
5. Professional Data Processing Tools
It provides powerful functions such as a formula calculation engine, data visualization (sparklines, common charts), conditional formatting, Excel-style grouping and filtering, and supports multiple worksheets and secondary expansion components, facilitating data trend analysis and outlier identification.
6. Seamless Integration with LIMS
LIMS focuses on overall process and process monitoring, while ELN specializes in paperless and compliant data recording. The two share information and complement each other:
- ELN can automatically retrieve sample, standard, instrument, consumable and personnel information in LIMS and verify the validity of results in real time;
- The calculation results of ELN are automatically pushed to LIMS, accelerating the circulation of test results and improving decision-making efficiency.
IV. Conclusion
The digitalization of laboratory management is an inevitable trend in the development of the industry. As core tools, LIMS and ELN ensure process standardization and data compliance respectively, and the two work together to promote the electronic transformation of original records. With the acceleration of social digitalization, paper records will be gradually replaced by ELN, laying a solid foundation for the high-quality development of laboratories.