June 30, 2020
With continued advancements in technology and the ever-changing needs of laboratories, LIMS has become one of the most important investments a lab owner can make in today's times to optimize data management and the overall operations.
Having said that, there still are businesses that use a paper or excel file-based system to manage all the lab data, invoices, client information, etc. This invites a number of challenges that adversely affect the overall quality and productivity of operations.
Below are a few of the most common drawbacks and challenges of using a paper-based system:
A LIMS offers a wide range of functionalities that help you fulfill the needs of your laboratory. It lets you manage your samples, testing and diagnostics data as well as other analytical testing workflow requirements, and has a plethora of distribution and reporting attributes. It allows you to organize storage hierarchies and assign a location to each sample which promotes easy tracking.
Manage Test Workflows: You can design, record, track, and generate results for qualitative and quantitative tests performed on samples. Another vital feature is that it helps you identify and locate any specific information across modules by querying the system. It also provides an easily configurable workflow to fit your unique environment and eliminates tedious manual entry.
Generate Reports: A LIMS also enables you to generate meaningful reports, authenticate test reports with electronic signatures, publish your laboratory's logo/signature for professional reporting services, and keep a track of all user activities performed in your lab with a comprehensive audit trail. Finally, you can streamline sample and storage requests received from within your organization or from external researchers and accept or reject a request to control access to samples and inventory.
Streamline Operations: A LIMS helps you with audit management, barcode handling, chain of custody, compliance, customer relationship management, document management, instrument calibration and maintenance, inventory and equipment management, manual and electronic data entry, method management, personnel and workload management, quality assurance and control, time tracking and performance assessment, data mining, invoicing and sales.
A LIMS is the most sought-after software-based solution because of its many advantages. One of the primary advantages of implementing a LIMS is that it establishes the quality of test results generated, by ensuring that reagents and supplies are not expired, instruments are accurately calibrated and tests are conducted by well-trained and competent staff.
It provides complete security from the moment the sample arrives in the laboratory through final reporting and disposal by providing role-based access permissions. A LIMS plays a significant role in ensuring accurate and genuine test results, generating an exhaustive certificate of analysis (COA), meeting regulatory compliance, including ISO/IEC 17025:2017 and ISO 22000:2018 accreditation, eases integrations, and helps meet many other data management needs.
One of the most significant advantages of a LIMS is that it enables you to meet your local and state-level regulatory requirements with ease. For example, a Biobanking LIMS is HIPAA and 21 CFR Part 11 compliant. The primary functionality includes safeguarding the Protected Health Information (PHI) of patients and maintaining the confidentiality of electronic records by the use of digital signatures and access level control. A Clinical LIMS helps follow guidelines like GLP, HIPAA, CLIA, and 21 CFR Part 11. A clinical LIMS is primarily required to be able to manage/track a sample, manage source details, maintain tests, and generate test teports. They also require study management, kits creation & tracking.
A Cannabis LIMS needs to follow ISO/IEC 17025:2017 and ISO 9001:2015 compliance, and 21 CFR part 11. Typically required features include a client portal, billing & services management, sample tracking, test management, ability to generate COAs, instrument management, document and resource management, etc. Instrument integration and state tracking integration are also required for this industry. A Food and Beverage LIMS supports GMP, GLP, 21 CFR Part 11 and ISO/IEC 17025:2017 compliance as well as FSMA and HACCP regulations.
An environmental LIMS should efficiently manage sample registration, testing, test results, and generate professional and personalized test reports. Additionally, it should support international guidelines and compliance such as 21 CFR Part 11, ISO/IEC 17025:2017, ISO 9001:2015, and NELAC. An oil testing lab needs to comply with the American Society for Testing and Materials (ASTM), ISO, and IP standards. Other compliance includes Good Manufacturing Practices (GMP), 21 CFR Part 11 of US FDA besides ISO/IEC 17025:2017, and ISO 9001:2015 Quality Management Systems.
A cloud-based LIMS, as the term suggests, is hosted on cloud servers. Due to this, the solution neither involves any initial setup, nor any implementation or onboarding costs. It also saves you time and the onboarding process is really short. A typical cloud-based LIMS solution will only cost a small fraction of the amount you'll invest in a conventional on-premise LIMS. Moreover, a cloud-based LIMS will save hiring and IT costs, as it is an instantly deployed, immediately delivered, managed, and hosted solution.
To set up a cloud-based LIMS, where all information is stored on servers is advantageous for labs with multiple users. Cloud-based systems require little hardware and software to be installed locally, making the set-up quick and lowering the cost of ownership.
By allowing colleagues to be assigned to various projects, they also make it easy to share data and workflows, even across labs in different locations, as each collaborator can access information from the LIMS anytime and anywhere.
You can also make changes to your LIMS remotely, and updates are performed automatically by the company that manages the software so that you don’t waste time updating it yourself (which usually requires putting the LIMS on stand-by temporarily if you update on your own).
A typical cloud-based LIMS has an SSL/TLS 1.2 (https) 256-bit encryption incorporated for all communication between the client and server. Logins are authenticated using a Two Factor Authentication process of passwords and OTPs. Data is accessed only by authorized personnel. Data is backed up for protection against thefts and physical damages. The servers on which the data is stored has firewalls, intruder detection, and has encryption to protect data in case of a breach.
You might need some other software like third-party billing software, Electronic Medical Record (EMR), Electronic Health Record (EHR), third-party software for instrument result parsing, and Hospital Information System (HIS) to complete your setup. This, however, can be easily facilitated as a LIMS can seamlessly integrate with the aforementioned software using APIs. Similarly, with instrument integration, test results from instruments can be directly parsed into a LIMS avoiding manual entry, transcription errors, and saving time.
Given its features, advantages, and the scope of configuration, making a LIMS a part of your laboratory gear has become the need of the hour due to its reliability and efficiency. A LIMS-powered lab stays ahead of its competition by performing efficiently, more reliably and accurately, and fulfilling all local and state regulatory requirements as well.