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

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

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

Effective Steps to Manage Laboratory Information Management System (LIMS) Software

Upgrading your clinical laboratory might be the latest enhancement you are implementing in your lab. This upgrade means you are automating the key functions to easily maintain the workflow. To make sure that your systems work in a smooth, harmonized, and safe manner, consider installing a cloud-based Laboratory Information Management system in your Lab. The cloud-based LIMS is no doubt the best choice to make as it has many advantages. A few of these are:

The data stored in the cloud are fully encrypted, hence 100% data safety.
Cost saving as there is no need for server maintenance.
With effective data recovery, any data loss can be reverted.
No manpower is required as everything is stored in the cloud, unlike physical servers.

Below are some simple tips to effectively manage your Cloud-based Laboratory Information Management System:

Implement a Cloud-Based Service Desk:

The most important step to do while implementing a cloud-based LIMS system is to provide a mini web page for clients to find information that caters to the needs of every patient. The internet is the influence king of the virtual world; so most of your patients will visit your website first, before heading over to your lab. Set up a cloud-based service desk and assist your patients just like you would do in your physical laboratory premises.

Make sure the webpage has a live chat facility so your customers can chat about the types of tests they can do and laboratory locations. Providing a live chat facility can help you to follow up in case the customers log out of the page suddenly. Also, features such as patient portals and customer portals empower your customers to download reports through the website making them completely independent.

Ease of Mobility:

Investing in a LIMS mobile app or website is the biggest advantage that Cloud-based servers can provide a laboratory. Since the data is stored at a remote location and is not bound by the constraints of physical hardware on the premises, investing in a mobile version of your laboratory’s website or even an App is a good idea.

You can take patient satisfaction to another level when you offer your patients and potential patients the ease to reach or access their health information on the go. With a virtual service desk in place, going mobile would mean more and better interactions and increased patient satisfaction.

LIMS Software Staff Training:

It’s essential to train laboratory staff to unlock the full power of your LIMS software application. To utilize LIMS software effectively, you can segregate the employees, departments wise, and provide training accordingly. Delegating one person as the head of training in every department can take the responsibility of providing LIMS-related knowledge sharing and periodic training. LIMS software training can include configuration options, storage, and retrieval of data, managing your workflows, and reporting. Staff training in each department is very important for businesses to succeed.

Increase Speed of Operation:

LIMS Software, specifically designed for laboratory information management, plays a pivotal role in optimizing operations. With a focus on pathology lab software, LIMS efficiently monitors various aspects such as Sample monitoring, sample workflow processes, patient visit count, inventory flow, cash flow, consultant performance, and overall business fluctuations over time. Through the analysis of these metrics, LIMS issues performance-based documents and develops standard quality indicators and key performance indicators, providing a comprehensive solution for laboratory management.

Additionally, Cloud-based LIS (Laboratory Information System) enhances the speed of laboratory operations. While technology facilitates remote meetings, Cloud-based LIS goes a step further by enabling access to data from any location, granting the user the necessary access rights. This feature ensures a swift exchange of information, contributing to an overall increase in the speed of laboratory operations. By seamlessly connecting personnel across different locations, the Cloud-based LIS becomes a valuable asset in streamlining workflows and promoting efficiency within the laboratory environment.

Ease up the Implementation Process and Quality Indicators:

The constant check of quality to ensure stability in business is a major requirement for any industry. With clinical laboratory, it is more of a service quality check rather than product one. Hence, quality indicators are of utmost importance to a laboratory.

LIMS Software, specifically designed for laboratory information management, can efficiently monitor various aspects of laboratory operations such as Sample monitoring, sample workflow process, patient visit count, inventory flow, cash flow, consultant performance, and overall business fluctuations over a period. The system analyzes these metrics to issue performance-based documents, and through the utilization of cloud technology, LIMS can develop standard quality indicators and key performance indicators.

By integrating a cloud-based LIMS System into your laboratory functions, you can optimize processes and identify areas for improvement. This innovative solution allows you to identify and understand your business metrics, paving the way for enhanced business optimization through the power of cloud technology. Whether it's managing sample workflows or evaluating consultant performance, the inclusion of LIMS Software, tailored for pathology lab software, brings a comprehensive and efficient approach to managing laboratory operations.

5 Effective Steps to Mana...

Effective Steps to Manage Laboratory Information Management S.....

Published by: Sanjana 2018082415:59:00

Investment in health is the best way of investment to lead a full and healthy life. People have started to invest in health and undergo health check-up regularly. People have started to realize that prevention is better than cure, and what better way to prevent than getting regularly tested and check on the well-being.

As the number of labs outgrows every day, utilization of machines to collect samples is also increasing. When labs get more samples to process from various sources, machine interfacing is helping labs in making their work easier and faster. In this blog, let’s discuss some of the best and modern ways by which labs can collect patient samples, avoiding all the hassle. The 4 efficient ways for lab sample collection are:

Walk-in sample Collection
Collection of the sample at Home
Business to business Sample collection
Franchise-based sample collection

Walk-in Sample Collection:

This method of sample collection is the most personal easily accessible way to collect samples from patients. In this era of online-based life, it is a step towards betterment that laboratory tests are also made available with ease of access.

Patients can directly walk-in into the laboratories and give the samples. Labs will process the sample in the laboratory and give reports. In case, the samples need to be processed by main processing centers, the samples will be sent to the main processing centers and then collected back by the laboratories after the processing is over. Patients will be able to collect their detailed reports from the laboratories they visited.

Sample Collection at Home:

For many patients, deviation in health is a sensitive issue. Sometimes trustworthy lab institutes might be far away from the patient’s home. This leads to long hours of travel and long hours of waiting for the test to be taken by patients. The whole process might be a bit demotivating for the patients and the increase in their stress.

In this case, labs will visit the patient's home and collect samples for testing. The healthcare industry is reaching new heights by making it possible for patients to remain in their safe confinement and get their health tested in their comfortable time without physically leaving their homes.

After collecting the samples they will be processed in the labs or sent to the main processing center and a detailed report will be obtained and sent to the patients.

Home Sample Collection is beneficial for:

Patients who are bedridden
Post-surgery patients
Elderly patients
Chronically ill patients
Pregnant ladies

Business-to-Business Sample Collection Lab:

There are more competitors in the field of healthcare than in any other field. Their competition is that they perform better in serving the health of other people. This service needs to be done in an effective and time-saving manner which would put the patient at ease with the laboratory.

Business-to-business helping with sample collection can help you gain more recipients and a number of doctors recommending your clinic. Two or more businesses who are specialize in various fields of laboratory testing can partner up together and jointly help each other in each field. Big labs can partner with small labs and collect samples.

This way the businesses can direct patients who need specific tests in a diagnostic not available in their own lab but available in the partner's lab. Business-to-business sample collection can help them mutually gain a lot of patients and thereby trust in the system.

Franchise-based Sample Collection Lab:

Establishing a fully equipped diagnostic center in a city is viewed more than a business opportunity and as a service to the better health of mankind. Such diagnostic labs should be working in their 100 percent capacity with state-of-the-art equipment that delivers quality results.

Attaining such a high level of quality for the sample collection lab is difficult if you start out fresh. It would be best to join an already established company and start a new franchise that can help in diagnostic sample collection.

Having a franchise with a top company in sample collection and diagnostics will help you better in getting more patients to the lab and better manage the center.

With the already established name and fame of the company, the job for you would be easy.

To know more visit Mocdoc - LIMS Software

4 Efficient Ways of Sampl...

Investment in health is the best way of investment to lead a .....

Published by: Sanjana 2018100815:02:05