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ISO17025 defi nes standards, reference materials, reference data, reagents, and consumables as equipment. Inventory management within the LIMS allows complete management and traceability of these items. Key data such as supplier, amount, expiry dates, lot numbers and Certifi cates of Analysis can be recorded. Stock levels can be tracked and linked to reordering requirements. Inventory usage can be linked to specifi c tasks, for example identifying the exact reagents, and amounts used, for specifi c analyses or analytical runs. Linking inventory to tasks in this way automatically updates stock levels, and provides traceability as to how and where reagents have been used.
Measurement uncertainty and Validity of results (Section 7.6 & 7.7)
Measurement uncertainty in calibration laboratories is a complex area. LIMS can play a role by automatically applying specifi ed limits during result entry. It can also handle more complex calculations when limits are not applicable. LIMS functionality, such as managing reference materials, tracking instrument calibration, controlling retesting and replicate testing, and generating control charts, ensures result validity. Additionally, LIMS allows correlation of results across different batches, as all the required data is centralised.
Reporting of results (Section 7.8)
Reporting is a crucial aspect of testing and calibration laboratories. It involves delivering the data and information generated by the laboratory to the consumer or customer. Accuracy and completeness are essential in reports, which must include all the information required by the customer. ISO17025 requires the review and authorisation of results before their release, and LIMS supports these steps. LIMS allows for fl exible reporting options, enabling the creation of customer-specifi c reports in the required format. By automating report generation and making them available for review after approval, LIMS streamlines the delivery of results to customers.
Managing complaints and non-conforming work (Section 7.9 & 7.10)
Figure 3. Example of Instrument Calibration and Maintenance in LIMS. 4. Process requirements:
ISO 17025 emphasises proper resource management and process requirements. Section 7 of the standard covers processes, offering an opportunity for LIMS to support process defi nition and enforcement, showcasing its value.
Section 7.1 outlines the requirements for the review of requests, tenders, and contracts in a laboratory. This process ensures that customer requests are feasible and covered by existing contracts. The use of a LIMS can enforce this review by preventing the processing of requests until they have been approved by a qualifi ed person. As customer portals become more common, this review becomes increasingly important to ensure the requests are valid. .
In Section 7.2, the focus is on selecting and verifying appropriate tests. LIMS can automate this process by assigning methods and tests based on the material being tested and other factors. It ensures the use of the latest method version and assigns relevant limits to validate results. LIMS allows the setup of projects for method validation and records the validation outcomes.
Sections 7.9 and 7.10 of ISO17025 refer to complaints and nonconforming work. Complaints need to be tracked and managed, while procedures must be in place for handling nonconforming work. A LIMS can manage complaints and non-conformances if it has an integrated Corrective Action, Preventive Action (CAPA) management facility. This facility enables tracking and management of CAPAs from creation to resolution, recording associated actions for full traceability of the process.
Figure 5. An Example of CAPA Management in a LIMS.
Control of data and information management (Section 7.11)
Figure 4. Example of Tests Dictated by Chosen Substance in a LIMS. Sampling (Section 7.3)
Sampling is crucial for maintaining consistency and reliability in calibration and testing laboratories. It involves the collection of samples, recording data such as sampling date and time, and the person responsible, as well as ensuring adherence to defi ned sampling plans. LIMS play a vital role in managing sampling data, providing unique sample identifi cation, and accommodating diverse sample information. LIMS must be able to support various sample types and adapt to new sampling requirements. ISO 17025 emphasises the importance of sampling and testing competence.
Section 7.11 Control of data and information management emphasises the importance of easy access to necessary data and information for laboratory activities. It raises questions about the ease of accessing critical information such as the latest version of Standard Operating Procedures, equipment calibration status, and availability of reagents. An integrated LIMS can streamline data access and management by consolidating all relevant information, including customer details, requests, contracts, training records, and technical records. This centralised approach ensures effi cient access to the required data set, even across different geographical locations , facilitating the smooth functioning of the laboratory.
Section 7.11 highlights the importance of validation in laboratory information management systems (LIMS). It acknowledges that LIMS can encompass both computerised and non-computerised systems, including paper-based or spreadsheet- based records. Validating these systems, especially paper-based ones, can be challenging. LIMS, with their integrated information and functionality, minimise the need to validate multiple systems. Many LIMS come with supporting materials such as validation scripts and packs, making the validation process easier. The pharmaceutical industry, with its experience in validation, has found LIMS to be well-suited for the task.
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