1. Project Construction Objectives
Through the construction of the STARLIMS system, we will achieve the following main goals:
1. Build a system with convenient operation, advanced framework, and no client configuration requirements through the construction of STARLIMS system;
2. The STARLIMS system fully complies with GMP requirements and CNAS laboratory accreditation requirements, and can assist the laboratory in compliance management;
3. Complete the mainstream process management, comprehensive laboratory management, product qualification certificate management, network connection of analytical instruments and automatic data collection, comprehensive query of laboratory information, etc. of all laboratory inspection businesses in the company, in accordance with the latest requirements of laboratory related standards, so that the laboratory can achieve information management and paperless office work;
4. Establish a quality management platform for enterprises to meet quality management needs. While querying laboratory data in real-time, the function of analyzing trend charts can be achieved through historical data analysis to obtain quality development trends, identify quality control problems, and achieve continuous improvement of enterprise quality management;
5. Establish a comprehensive management platform for laboratory business to comprehensively manage the personnel, machinery, materials, and methods of the laboratory. Through internal control within the system, implement various management regulations of the enterprise, ISO/IEC17025 standards, and GB/T 15481-2000 standards;
6. Implement integration with other third-party information systems such as MES, ERP, real-time databases, OA, etc;
7. Enhance the competitiveness of the laboratory. By introducing advanced testing and testing integrated platforms from abroad, it will promote the integration of the laboratory with international standards, enhance the overall service image of the laboratory, enhance the competitiveness of the laboratory, and safeguard the rapid development of the laboratory.
2 Project Construction Plan
2.1 Inspection Business Management
2.1.1 Sample Login
The sample login in the laboratory can be done according to different types such as finished products, semi-finished products, process samples, raw (auxiliary) materials, water quality and environmental protection samples. Record different sample information when logging in for different samples. Different login methods should be adopted for different sample login systems:
1. For samples with a fixed sampling time, the system should be able to automatically log in according to the pre-set schedule time;
2. For the initial stage of device operation or finished products, raw material samples, etc., the sampling time is not fixed, and a single sample can be manually logged in.
When tasks can be assigned to ERP, MES, and other systems, automatic sampling can be performed through the system interface.
2.1.2 Sampling reminder
For samples that need to be sampled, sampling reminders can be provided in the system, and sample labels with barcodes can be automatically generated. Labels can be printed in batches, and the workload of sampling personnel can be counted and queried by time, department, or personnel.
2.1.3 Sample reception
For analytical samples, scanning gun reception or manual batch reception can be achieved in the LIMS system, and the system will record the sample reception time, recipient, and sample retention management in detail.
2.1.4 Task Assignment
The system can achieve two methods: automatic analysis task assignment and manual task assignment.
2.1.5 Result Entry
The LIMS system provides multiple flexible, simple, and fast ways to input analysis results into the system, enabling automatic collection, rounding, and calculation of analysis data.
2.1.6 Result Review
Can freely set audit levels and set different audit levels for different samples.
2.1.7 Automatic report generation
The system automatically summarizes the original record template format required by production users after reviewing the published data, and can also generate report forms and various types of qualification certificates according to the format required by customers. LIMS is integrated with crystal reporting tools to automatically generate a certificate of conformity or report form with a stamp or electronic signature.
2.1.8 Analysis data modification
After analyzing the data and discovering errors, the LIMS system should provide data modification function. The modified data should leave traces, and the modified data should automatically replace the error data that was previously uploaded to MES or other systems.
2.1.9 Sample management
After all the project data of the samples are generated and reviewed, the sample retention management module of STARLIMS can achieve the retention of the samples. When the retention sample expires, the system automatically reminds relevant personnel to handle it.
2.2 Laboratory Resource Management
2.2.1 Personnel Management
It should include basic information of personnel (education, professional title, training status, etc.), authorized usage methods, instruments, etc., and ensure consistency in job certificates. Ensure that you have not passed the onboarding assessment and are unable to perform testing project operations and result entry.
2.2.2 Instrument and equipment management
All analytical instruments in the laboratory are archived in the system, achieving automatic data collection for instruments that meet collection conditions. Expiration reminders are provided for instrument calibration and periodic verification in the system, and records after calibration and verification are managed in the system.
2.2.3 Material Management
1.Material, standard sample, and reagent management includes: reagent purchase, warehousing, requisition and distribution records, verification records, verification regulations, verification methods, verification reminder functions, consumables management, and reagent damage management, and can provide tracking management for inventory reagent warehousing, storage, and outbound;
2. Provide management of reference materials, chemical reagents, standard solutions, and other reagents;
3. Provide records of chemical molecular structure, physicochemical properties, hazards, and other information of reagents;
4. Provide query function to query detailed information of reagents and perform queries based on any combination of conditions.
2.2.4 Method management
Organize all testing methods used in the laboratory, establish a testing method management library, and associate it with testing projects to ensure that all testing methods for all testing projects are current and effective, and can be version controlled.
2.2.5 Environmental Record Management
The system provides a function to record the temperature, humidity, pressure, and other details of the laboratory rooms in detail, making it easy for analysts to query.
2.3 Laboratory Work Management
2.3.1 Message Management
Provide instant messaging functionality, allowing internal users in the laboratory to send instant messages to specific users or user groups.
2.3.2 Shift handover management
Detailed handover content can be recorded through the LIMS system to manage the handover work of shift teams.
2.3.3 HSE Management
Detailed HSE related information can be recorded through the LIMS system to manage laboratory safety, environmental protection, and health related work.
2.4 Data Query and Statistics
2.4.1 Data Query
National or enterprise standards can be set for each sample. During testing, all samples refer to the corresponding national or enterprise standards, and the exceeding items will be automatically marked and reminded. The data analysis tool of LIMS can be used to statistically and analyze data exceeding the standard, thus achieving comprehensive quality evaluation.
1. Sample status;
2. Device Daily Report;
3. Sample ledger;
4. Trend chart.
2.4.2 Data statistics
1. Quality statistics;
2. Device qualification rate;
3. Product/raw material qualification rate;
4. Correlation analysis;
5. Data grouping;
6. Biaxial curve.
2.4.3 Chart data
Provide visual data analysis tools that can analyze data and present it in various chart formats, such as dashboards, scatter plots, bar charts, pie charts, etc.
2.5 KPI statistics
Through the data analysis tool of STARLIMS, sample data and costs can be statistically and analyzed, thus achieving various statistics:
1. Viewing the Labor Cost of a Single Analysis Method;
2. Analyze labor hours and cost statistics;
3. Instrument workload statistics;
4. Sampling rate statistics;
5. Sample quantity statistics;
6. Timely inspection rate;
7. Analysis error rate statistics.
2.6 Large screen display
STARLIMS provides a large screen for relevant personnel to view in a timely and convenient manner, such as task progress, key task dynamics, sample analysis conditions, sample qualification rate, key control points, analysis daily reports, analysis personnel status, laboratory human machine material method environment (including analysis cost, equipment workload, personnel working hours, sampling rate, etc.), and other information.
2.7 Mobile Applications
The STARLIMS mobile application platform includes functions such as task reminder, process approval, report approval, procurement approval, progress viewing, and message preview.
2.8 Instrument Interface Scheme
1. Can achieve bidirectional data transmission with CDS system;
2. Realize the automatic collection and transmission of data that can be output by single workstation instruments into the system, and complete the automatic collection and transmission of data;
3. Can be integrated with automatic instruments with RS232 and USB interfaces, such as analytical instruments such as balance, density, potentiometric titration, etc. This type of instrument supports mobile acquisition.
2.9 System Integration
STARLIMS can be integrated with other application systems in various ways, while meeting the technical standards related to interfaces:
1. By file;
2. Database Interface Interconnection (ODBC);
3. ActiveX/OLE;
4. Web Service;
5. Integration process record/system integration interface log.
3 System Security Design
3.1 Login Security Management
1. In a multi user environment, the system must provide reliable security, allowing all data to run in a controllable system and achieving multi-layer security access permissions;
2. You can specify a detailed definition of the user's permission to operate on a certain type of data;
3. Classify personnel by role and define different operation permissions for different roles;
4. Users can be managed by group, and a group can only operate on the data of the corresponding group;
5. Due to the authority of quality data, all sample analysis data should have an electronic signature, which must comply with the regulations of FDA CFR 21 Part 11.
3.2 System Data Security Management
1. Automatically retain user role changes and access records;
2. To ensure the security of the database, LIMS data should provide scheduled automatic incremental backup and manual full backup data solutions;
3. The database system should have a complete and stable scalability for long-term operation. As data increases, it can support dual machine backup of two database servers when necessary.
