2018082215:58:39

Using LIMS for Quality Control Process

Published by: Sanjana

Keeping up with the fast-evolving world of trends means that smart work with innovation is required. Having a smart infrastructure built on informatics solutions can benefit the lab by implementing automation. Laboratory Information Management System (LIMS) is a critical part of the system to be incorporated in all functioning laboratories for better results. The LIMS of today has gone far beyond just sample management invoking functions like resource management, workflow management, and many more. By adhering to the National Accreditation Board for Testing & Calibration Laboratories (NABL) standards, labs can manage NABL quality indicators easily.

Quality control in Laboratory Information Management System (LIMS) Software:

Quality control in LIMS Software is the process of assurance of quality at every stage included in the automation system. It may also be called a statistical process used to evaluate the analytics produced in the patient’s results. The sampling of the product is continued after every successful stage until the end of the sample management process. Quality control is essential in LIMS used in clinical laboratories as the result cannot be tampered with. Quality control is done on three major factors in a clinical lab, which are:

Quality control on the sample
Quality control of the utilized equipment
Quality control for the process

For quality control of the sample, the result might either be quantitative or qualitative. This means that the result can either be a number count (hemoglobin count in the blood) or can define if the test result is positive or negative or can be limited to a few different values alone.

Quality control checks on the equipment or instrument are used to validate whether the instrument is operating within pre-defined specifications, inferring that patient test results are reliable. Once this validation is completed, the result of the patient can be used for further diagnosis.

Sample management:

Sample management is the primary process of a LIMS system. Any QC lab needs to analyze many kinds of samples depending on the industry of the laboratory. Our QC laboratory helps in the analyses of samples in a unique and distinct method. We have the following salient features for sample management:

Single-sample management and multi-sample management by using templated management techniques.
Sample recognition field that can easily identify the sample and log in the details, minimizing manual data entry.
Barcoded labels for sample tracking.
Implemented workflow automation features for reduced confusion and increased productivity.

Preparation and Method Execution:

We have predefined execution methods for sample tracking, analysis of tracking response, complaint reception, reducing the dead time, and overall increasing the efficiency of our system.
Special features for execution such as content uniformity, dissolution, stability, etc.
Strict preparation and method execution policies like standardization, tracking of reagents, control of the environment, trainees, and equipment analysis.

Report Management:

We understand the importance of report generation and sensitivity in handling the report data. Hence we have assembled the following features for report management:

Instant visualization of any abnormal notifications.
Configurable testing methodologies and calculation techniques for managing high variant products.
Multiple level approvals with comment entries for sensitive results.

Specialized Reporting:

Flexible facilities that are fully configurable to the product and customer level including layout, content, units, significant digits, etc.
Bi-directional integration with SAP-QM or SAP Batches for finished product testing. Interfaces to other ERP/MES systems are available.
Streamlined delivery of event notifications and results to end-users via e-mail, fax, etc.

Decision Support:

The documents like SOP, analytical, maintenance, etc. are version-controlled for ISO standard compliance.

Features:

As important as quality control is in laboratories, so is analyzing the proper features best suited for every laboratory and making use of them appropriately. Some important Quality control features are as follows:

Latest and updated versions of specifications are available on request.
Multi-level product specification management is made with controlled releases.
Sample management, sample storage, and reserve management are all done with accuracy.
Sample planning with the batch-wise process and test plan management is done.
Templated sample management by templating the sample at registration is effectively carried out for sample tracking.
Quality control is done at multi-level, multi-departmental, and multi-premises.
Workflow management with work schedule according to work plan for analysts and instruments alike.
Accuracy in result capture and OOT management.
Quality control on instruments by instrument calibration and regular maintenance scheduled at different time intervals with a proper update on status lock for instruments.
Training on the new releases and sample management for every instrument is carried out for every lab personnel
Any deviations from the original workflow are promptly recorded and validated.
Stability in the study module is maintained.

LIMS System quality control process allows managing the data of products, samples, and instruments alike regularly by monitoring at various levels. This ensures that quality can be monitored and, if necessary, actions to improve quality.

Related Blogs

As labs are updated and become more modern, better methods of data management and record-keeping may be necessary to maintain or improve efficiency. Luckily, there is a means to achieve this: Laboratory Information Management Systems, or LIMS.

With the increase in disease and the growth in the medical diagnosis sector, the number of samples collected is increasing day by day. With the help of Machine interfacing, labs can handle a large volume of samples easily, increasing the efficiency of sample processing and the quality of lab reports.

Types of Machine Interfacing in Laboratory Information Management System(LIMS):

Uni-Directional Instruments:

Overview: Uni-directional instruments operate on a one-way communication system, facilitating the seamless transfer of information from the samples to the Laboratory Information Management System (LIMS). In this setup, results are stored within the LIMS database upon the completion of the test process. Unlike bi-directional instruments, which support two-way communication, uni-directional instruments focus on unidimensional data flow.

Workflow Process: The workflow involves manual sample placement by the technician, who assumes the responsibility of strategically positioning samples for analysis. Additionally, the technician plays a crucial role in determining the specific type of sampling method to be employed. This hands-on approach ensures that the instrument receives accurate and relevant data for subsequent processing.

Result Storage: Upon completion of the test, the results are systematically stored in the LIMS database. This unidirectional flow of information simplifies data management, with the LIMS acting as a centralized repository for comprehensive result storage. This streamlined process contributes to the efficiency of data retrieval and analysis within the laboratory setting.

Technician Involvement: The technician's involvement is pivotal in the uni-directional instrument setup, as they guide the initial placement of samples and make informed decisions about the sampling technique. This level of manual intervention ensures precision and control over the testing process, aligning with the laboratory's specific requirements and protocols.

Uni-directional instruments, by emphasizing one-way communication and manual input from skilled technicians, contribute to a structured and controlled laboratory environment where data accuracy and integrity are paramount.

Bi-directional Instruments:

Advanced Functionality: Bi-directional instruments represent a higher level of sophistication and advancement in laboratory technology. These instruments possess the capability to not only generate output data reports and results but also feature an Application Programming Interface (API). This advanced functionality enables the seamless exchange of data, information, commands, functions, and worklists with the system.

Output Data Reports: One key feature of bi-directional instruments is their ability to generate comprehensive output data reports. These reports provide a detailed analysis of test results and relevant information, offering a comprehensive view of the findings. The generated reports serve as valuable documentation for further analysis and decision-making processes.

Results Generation: Bi-directional instruments excel at producing accurate and timely results. The dual communication capabilities allow for efficient data transfer, ensuring that results are not only generated promptly but also transmitted seamlessly to the designated system or database.

Application Programming Interface (API): A defining feature of bi-directional instruments is the inclusion of an Application Programming Interface (API). This interface facilitates the exchange of data, information, and commands between the instrument and the broader laboratory system. The API functionality enhances interoperability, enabling the instrument to import and export data with ease.

Enhanced Connectivity: Bi-directional instruments contribute to enhanced connectivity within the laboratory ecosystem. The ability to import data, information, commands, functions, and worklists through the API fosters a dynamic and integrated environment. This connectivity streamlines laboratory processes, promoting efficiency and accuracy in data handling.

Our LIMS System sends commands to the sampling unit on the type of sampling to be conducted with the given sample. After the testing is done by the LIMS command, the results are auto-fetched on the LIMS Server. The bi-directional instruments are interfaced with the LIMS system programmatically.

The Need to Interface Instruments with LIMS Software:

There are several reasons why it is beneficiary to interface lab instruments with LIMS Software. Let us look into a few reasons here:

Increase in Productivity by Effective Machine Utilization:

Interfacing your instruments with your LIMS Software is a one-time investment of cost and work with a repetitive increase in lab productivity and effectiveness. Interfacing LIMS Software with your lab instruments removes many complexities like manual entering of data every time or referring data from other instruments to the LIMS. This altogether saves a lot of time and effort when done by a LIMS rather than manually, also avoiding any human errors during data entry.

Utilizing machines effectively can increase productivity drastically. When the task is done manually, very few samples are completely analyzed in the given period, but with MI they can perform many sample processing and that will increase machine utilization and increase revenue.

Increase in Data Quality by Reducing Manual Errors:

The second best reason for interfacing your lab instruments with your LIMS Software is the increase in data quality and integrity. As a human, we are eligible to commit human errors that might not be over-influential over the system as a whole but might still be considered an error. By removing human interference, these errors are avoided thereby guaranteeing better data transfer in the system.

Similarly, transcribing data into the system by people can also lead to common errors affecting the quality of data. Data integrity is considered a very important issue in laboratories. By interfacing your instruments to your LIMS System, you will eliminate this issue.

Saves Time in output generation thereby satisfying the patients:

Machine Interfacing helps to analyze the given samples at a faster rate and generates quality results within a shorter duration of time. After the result processing is done, the report will be generated manually.

With the use of MI, ultimate patient satisfaction can be achieved by generating the results in a quick manner with good quality.

Machine interfacing in laboratories is more of a comfort rather than a negative factor. What might be a one-time investment in your labs can save a lot of time and work when interfaced properly with your systems.

Why Machine Interfacing i...

As labs are updated and become more modern, better methods of.....

Published by: Sanjana 2018092708:52:44

Laboratory Information Management System is an extensive solution, designed to cater for the needs of the medical testing labs, and facilitates seamless monitoring of the lab’s operations by streamlining the processes.

The demand for medical lab services is high and keeps increasing with time, which makes it critical to ensure efficient and high-quality customer service. A sample management system is required to handle this necessity. An appropriate Sample Tracking system guides a medical examiner in streamlining the sample lifecycle, monitoring and operating the laboratory processes, with its comprehensive overview of the test sample. This ensures that nothing is overlooked, from sample collection to movement, to arriving at the test results, by tracking the entire workflow and recording the status.

MocDoc’s reliable laboratory management software performs the sample tracking task, maintaining quality standards and also helping to improve operational efficiency.

The Sample Lifecycle:

The Sample Lifecycle is an integral part of laboratory operations and encompasses three distinct phases: Pre-Analytical, Analytical and Post-Analytical. Managing the sample lifecycle effectively is essential to ensure accurate results and avoid any leaks or errors due to poor sample management.

● Pre-Analytical phase: The Pre-Analytical phase begins when a test order is placed and the sample is collected. The sample goes through the process of accession, where it is acknowledged or rejected for testing. If the sample is accepted, it is then segregated based on the type of sample and the department

● Analytical phase: The Analytical phase is a step of utmost importance, in the sample lifecycle, where the collected and segregated sample undergoes the ordered test and results are generated. In this phase, the laboratory staff will be responsible for selecting the appropriate test methods, preparing the samples, running the tests and ensuring that the recorded results are accurate, precise and consistent.

● Post-Analytical phase: The Post-Analytical phase is the final and crucial step in the sample lifecycle, where the test results are reviewed and verified for accuracy and completeness by a professional, such as a clinician or a doctor, and any necessary corrections or amendments are made. The final report is then generated and delivered to the patient.

The special features of the MocDoc LIMS Sample Tracking system:

Monitoring a sample’s progress throughout its lifecycle helps the professionals in managing the laboratory processes effectively, by analyzing the duration it spends in each department. This enables labs to maintain a satisfactory TAT consistently and also facilitates identifying the cause of any testing delay.

Sample Recieve Workflow:

The Sample Receive Workflow feature in MocDoc LIMS streamlines the process of receiving samples in a laboratory. Sometimes, the samples collected from the patient in the accession department may not reach the processing unit on time, hence it is important to track the sample's arrival time for maintaining allocation turnaround time. With a simple barcode scan, technicians can efficiently receive and track the sample's arrival time, ensuring that the testing process remains within the allocated turnaround time (TAT). This feature is essential for accurately monitoring the progress of samples and ensuring that the results are produced on time.

Staged Process Workflow:

The testing process carried out for a few samples may involve various stages such as cassette preparation, and specimen staining, before the final test results are obtained. These processes can vary depending on the type of test being conducted. It is crucial to monitor these processes to determine the current status of the sample and the time taken for each stage of processing.

This is accomplished with the "Staged Process Workflow" in MocDoc, which tracks the progress of each test at every process, keeping a record of the sample's journey from preparation to completion. The workflow also provides insights into the time taken for each intermediate stage. Customized workflows can be created for each test, based on its specific requirements.

With the advent of technology, the MocDoc LIMS System has made the process of tracking samples simpler. MocDoc's Sample Tracking module allows you to track the status of the samples throughout their lifecycle, from the time of collection to the time of archival, which in turn helps the labs maintain their brand reputation and service standards

Streamlining Sample Track...

Laboratory Information Management System is an extensiv.....

Published by: Preethi 2023022316:26:27

An Introduction to LIMS Software:

Laboratory Information Management System (LIMS) is software that is used in labs for data management and to process a large number of lab samples to manage laboratory workflow. With LIMS, the lab can automate workflows, integrate instruments, and manage samples and associated information. Additionally, labs can produce valid results quickly and can track data across experiments to improve efficiency.

LIMS that are commonly used in clinical labs fall under the following categories:

Clinical Chemistry Analyzers
Diagnostic Testing
Quality Control Software
Immunoassay Systems etc.,

The benefits of using LIMS Software in your lab are:

Workflow automation
Integrate instruments or other in-lab systems
Centralize access and storage of data
Track data from sequencing runs
Initiate downstream data analysis

The Efficiency of LIMS System:

The main purpose of using the LIMS System in a lab is to improve the efficiency of sample processing and management. Using LIMS would cut down on the need for manual tasks thereby increasing the accuracy of sample analysis. LIMS captures data automatically, gets processed, and is stored for future reference. The LIMs vendor you choose will define the proceeding process of the software.

Generally, the process of a LIMS is divided into five stages:

The sample is logged in after reception.
Assignment, scheduling, and tracking of the sample and the analytical workload.
Processing and quality control associated with the sample.
Storage of data associated with the sample analysis.
Inspection, approval, and compilation of the sample data for report generation and further analysis.

Types of LIS Modules Used In Clinical Laboratory:

The features of Laboratory Information System (LIS) have seen evolutionary growth over the years from sample tracking to enterprise resource planning for clinical and specialty laboratories.

A typical workflow pattern of a LIS in a clinical lab flows through three phases:

Pre-analytical: Specimen collection.
Analytical: testing of the specimens.
Post-analytical: Result review.

The LIS modules are used by various laboratory departments like:

Blood Bank
Immunology
Hematology
Microbiology
Clinical chemistry
Histopathology

Various Common Functionalities Used In LIMS:

With the progress in technology, the functions of a LIMS progress too. LIMS software is built in a way to support any upcoming progress while effectively working on a basic set of definite functionalities like the collection of data, tracking of samples, processing, data storage, and report generation.

Some of the core functionalities of LIMS are explained below:

Sample Management:

LIMS was created to help in the process of sample management systems occurring in laboratories. This system gets initiated when a sample is received in a laboratory and gets registered in a LIMS. Since a large number of samples are collected and analyzed in a day, it would be difficult to record the samples without the chance of being confused with other analyses. With LIMS, It would be easier to track the sample if it is labeled and assigned correctly by using RFID on the samples or barcodes.

The information collected and stored via a LIMS would fall under the following criteria:

Details about the person whose sample is taken.
Details of the doctor/clinic who recommended an analysis.
The tests/analysis needed to be taken on the sample.
Stages of the sample and destination.
Storing procedures.
Expected report generation date.
Record creation for future purposes.

Workflow Management:

The need for workflow management using a LIMS is as important as Sample management and record-holding. The accuracy of a working system does not just depend on the data; it needs an on-point process assessment where a LIMS system can be used. As the name indicates, workflow management helps automate workflows and assign work if delegated precisely in the software.

All you would have to do for better workflow management using LIMS is:

Enter proper codes to direct the LIMS system for a work assignment.
Configure the process flow of the work for sample analysis.
Assign exact instruments for the particular work.

Workflow management using a LIMS saves time and conducts the job with precision.

EMR/EHR Software:

Electronic Medical Record (EMR) / Electronic Health Record (EHR) is software that collects and stores information on the patient’s medical history in the form of records that can be shared via different healthcare mediums. Many LIMS have this EMR/EHR Software functionality built-in in their system. Using a LIMS with an EHR function will be a huge asset to your lab as the real-time data exchange can be made possible easily.

What is laboratory inform...

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Published by: Sanjana 2018080807:57:04

In every industry, modern laboratories are under pressure to enhance operational efficiency, decrease costs, control regulatory compliance, and improve quality. Apart from this, the rise of CRO (Contract Research Organization) and R&D externalization strategies in the industry of pharmaceuticals has led to laboratories gathering enormous data from different partners, preceding a significant increase in the complexity of lab workflow.

LIMS (Laboratory Information Management System) and informatics Solutions are being used in the pharmaceutical industry to meet these challenges. The main reason why cloud-based LIMS is preferred is due to its advanced features like

● Decreased cost,

● Automatic software updates,

● Disaster and backup recovery services,

● Rapid implementation of LIMS,

● Flexibility,

● Security,

● Accessibility,

● Collaborations.

One of the successful Laboratory solutions and laboratory report software used by most users is SaaS. Let's explore the SaaS in depth below.

What is SaaS?

SaaS(Software as a Service), is one of the software distribution models and types of cloud computing like IaaS and PaaS. The third-party provider hosts the program rather than downloading and installing the software to run on your PC. Once the software is hosted, it's accessed over the internet by users via a web user interface.

Why SaaS, a cloud-based LIMS, is perfect for your lab?

SaaS, pathology management software provides plenty of excellent benefits that make it the preferred option of every lab. According to the Forrester Research Inc. survey held last year, 15% of SMB (Small to Medium Businesses) and 16% of the larger organizations make use of SaaS. Compared to the previous year's research, the larger enterprise has seen a 33% increase in the Usage of SaaS. Considering the smaller enterprise, they have seen a 50% increase in SaaS. Below are some reasons to state why Cloud-based LIMS is the right option for your laboratory.

Hosting Options:

Few providers provide the private cloud option that can host within your facility. The private cloud option offers different SaaS LIMS benefits but with fewer security risks. A cloud is public; either it can be private, single-tenant, or multi-tenant. It's easier to validate the single-tenant cloud when compared to the multi-tenant as they are less prone to intrusion or data leakage.

Data Integrity and Audit Trails:

A permanent audit trail is vital for addressing different concerns in data integrity, both from the perspective of product and regulatory quality. You need to ensure that your SaaS LIMS holds a detailed and reliable audit trail for every piece of information. You also need to make sure that the data is maintained continuously on the various servers rather than on the data itself.

Apart from that, you need to ensure that your provider has set their system default to store a completely reliable and flexible audit trail. It also controls the network logs and detailed server. It offers data center third-party auditing insurance. You need to ensure your SaaS LIMS is capable of integrating with the other informatics systems and with your instruments.

Service Level Agreement:

You must develop a Service Level Agreement with your provider who will be able to address all of the above-concerned areas and more. A Service Level Agreement that is well written is capable of making the variation between a smooth execution & roll out of your SaaS time overruns, cost, and a few of the unexpected expenses incurred.

Security:

When dealing with a SaaS Laboratory Management System, you will depend upon your providers to secure your pieces of information as it is going to be stored in the cloud. Almost every cloud service provider offers excellent security for your valuable data.

Even though the data breach risk is less, few organizations that belong to heavily regulated areas hesitate to enable their information to move away from their firewall. Make sure you have evaluated the policies of your security thoroughly. It means you have your data secured adequately before working with SaaS LIMS.

Validation:

The important compliance responsibility with every regulation resets with the service provider or manufacturer. Most of the vendors advertise these cloud-based SaaS LIMS as a prevalidated system. But this refers to the network of cloud providers. You need to ensure that you get clear about the meaning of the prevalidated system by the vendor. Also, you need to know what scope is covered so that you can know your system is executed in the right way in the user environment.

Apart from that, SaaS LIMS cloud providers handle every clinical laboratory software patch and upgrade. It ensures that you utilize the system's recent version. You need to understand who should manage revalidation once there is an upgrade or patches take place.

Business Continuity:

You need to understand how data recovery and backup can be handled, and also explore who is the reason and responsible for it. The details of the guarantee like service, response time, hardware, uptime, etc. provided by the provider should be stated clearly in the SLA (Service Level Agreement). Apart from that, the Service Level Agreement should contain the details of recovery and backup services that are included. Also, it should hold the cost incurred by exploring a few of the optional services.

System Failover:

There can't be anyone who didn't use Google. For instance, what will happen in case a rogue asteroid crashes into the server farms of Google? Nothing happens. Airtight failover technology and Mirrored servers indicate that the news service will display the crater's aerial photos, which once acted as the server farm. High availability and uptime are included in the terms & conditions of the cloud deals that are negotiated in any form.

Instrument Interfacing:

The complexity of the SaaS LIMS is challenging. Private, hosted, and On-Premises cloud LIMS is capable of handling instrument interfacing in the same manner. It is difficult to understand the SaaS LIMS cloud providers' ability, track record, and philosophy when you deal with the instrument interface.

Economics of Scale:

SaaS LIMS cloud providers provide you with more or less due to the technology's specialized use. As many customers utilize identical resources at the same cost, data centers, are slashed, and then the savings are passed to the customer.

Bottom Line:

In the past few years, technology providers have developed cloud-based SaaS LIMS based on market demand. SaaS LIMS enables to facilitate enhanced scalability, agility, innovation, and connectivity across the lab environment. It helps to increase efficiency in operation as well as decrease cost. The decision to make use of a cloud-based SaaS LIMS will be taken into step by a mix of various concerns like regulatory, operations, and security. The best way to ensure that your corporation benefits the higher from a SaaS approach to a laboratory information management system is to work with a top-notch informatics consultant.

Is Cloud-Based SaaS Labor...

In every industry, modern laboratories are under pressure to .....

Published by: Sanjana 2019121012:33:42