The key factors in implementing the LIMS in pharmaceutical industry
LIMS An introduction
Laboratory Information Management Systems (LIMS) are the software tools that help automate the collection and management of the data generated in a laboratory. Many of these products let companies store data in commonly used databases, and they also interface with analysis equipment to collect experimental data. Complete LIMS implementations also supports information gathering, decision making, calculation, rev iew and release into the workplace and away from the office. Effective use of information is a key task for every laboratory. Research and development laboratories need systems and procedures that can automate analytical processes and effectively share information. With the ability to make more real-time decisions, researchers can identify, and elevate promising candidate compounds to NDA, while eliminating non -viable candidates as early in the process as possible. LIMS systems that effectively serve pharmaceutical and life sciences research and development endeavours must offer a flexible set of features that adapt rapidly to changing workflows, materials and analyses. Configurable templates help to automate the workflows within the lab, including the creat ion of sample records, the assignment of testing and the collection of results, even in dynamic environments.
Requirement of LIMS in pharmaceutical industry?
Pharmaceutical industry is unique in many ways. Diverse laboratories, regulatory constrains, complex batch management and testing needs, all are the challenges which are been faced by the pharma industry in this current economic session. For all these challenges, the industry needs an sophisticated and enterprise - level information system. The most important factor which determines the need of the common information system is the wide diversity of laboratories of a company in a country. Combinatorial chemistry, screening, preclinical and clinical bio analysis, analytical chemistry, manufacturing R&D and production quality control (QC) all have unique needs and workflows. For all these work charts there are different operators performing their work under lots of pressure from the upper management to make thing do with a system already used in another part of the company. In some cases it can work, but more often than not the result is a failed implementation, and a lot of unhappy (and potentially unproductive) users. In general, the industry is rapidly acknowledging that one tool cannot possibly meet the n eeds of these diverse users. True solutions must solve the business pain of the end users. Pharmaceutical industry is also face intense pressure from the regulatory affairs than any other industry. Any potential solution must satisfy the concerns of both internal and
such as product specifications or study protocols. Instrument calibration and maintenance status tracking . failure reports that trigger an automatic email for any tests that fail or automatically print certificates of analysis once a sample is approved. Eliminating these calculation errors also reduces your sample turnaround times by eliminating the need for paperwork to travel from an auditor back to the analyst for calculation or significant figure corrections. 4. Electronic capture of laboratory data . Automatic reduced test scheduling . become more efficient. the instruments status automatically changes to show that it is past its due date and the appropriate sample logged. the vast majority of pharmaceutical companies are being challenged to become more efficient.Since the data is now stored electronically. This includes the flexibility to support widely varying review and approval workflows for both static data. For example an iron limit test that may be only performed every tenth lot can be automatically set up to only show up on the appropriate samples. and dynamic data.Data can be transferred electronically or manually from lab instruments into your LIMS system.Tracking and scheduling reduced testing can be automated. validated calculations . Automatic. Data mining and reports . 5. This eliminates calculation errors as well as a manual second check of calculations. When a calibration due date is reached.Reports can be created and set up to run at a certain poi nt in a sample's life cycle. such as test results and batch disposition. Fin ally. creating certificates of analysis or other necessary reports are now just a few keystrokes away. Reports can be created to query your results for user defined tests and time frames. No more manually compiling all of your data! In addition. Some examples of this are: print sample labels when at sample log in. When the testing is performed and passes. and pharmaceutical companies are facing the same pressures to streamline. and focus on core businesses. data trending can now be done quite easily.external auditors.
Benefits of LIMS
1.Instrument calibration and maintenance testing and frequency as well as an instrument's current status can all be tracked in some LIMS systems.Perform any necessary calculations electronically. The massive profits of the blockbuster drugs are quickly becoming history. the status is then automatically changed back to an approved status. Event triggered reporting . 3. Filing and storage space for these records are also eliminated. 6. This basic feature of a LIMS gives you both compliance and time savings benefits. Lab notebooks or analytical worksheets are no longer needed for any testing captured in your LIMS. 2.
By setting the fields up to only allow the user to choose reagents that have not yet reached their expiry dates. on the other hand. Reagent status tracking . there has been a lot of interest in COTS.
What are the factors to be considered before purchasing COTS (commer cial off the self) Pharma LIMS
Recently. The truly novel aspect to the new solutions these vendors are developing is that. Similar to linking instruments to each test. and tight regulatory requirements.7. offers control over the software without requiring any additional code. Historically.or industry-specific
. you can also link your reagents to your tests. complex specifications and test methods. For years now. Unfortunately for the pharma industry. in order to appeal to as wide a market as possible across multiple industries. LIMS implementations in pharmaceutical R&D and QC have req uired extensive customization. and it is being used frequently in reference to software. as the basic functionality was close enough to their requirements to require little customization to the softwar e. LIMS vendors have designed their systems as generically as possible. This new buzzword in the pharmaceutical industry means Commercial-Off-The-Shelf.Each test can be set up so that there is a field to link an instrument to it. This is a difficult task to maintain manually. But currently some vendo rs finally recognize the scenario and try to build a solution which can actually satisfy the pharmaceutical business needs.Many LIMS offer a module to track your reagents and ch emicals. this approach was less problematic. life was not quite that simple. By setting up every reagent in your lab in a chemical inventory system within your LIMS you can easily run a report that shows all reagents to expire within the next 30 days. In some industries. Yet vendo rs have resisted incorporating industry-specific functionality. rather than trying to append stopgap solutions to aging architectures. There is long debate over the customization and configuration to decide whether the software is COTS or not. The LIMS will automatically change the status of reagents when the expiry date is met. Due to the batch-oriented production processes. While formal data are not currently available. you can eliminate compliance and retesting issues. pharma customers have been asking why they continually need to rebuild what they consider should be standard functionality in their LIMS. anecdotal evidence indicates that the majority of pharmaceutical customers would pay a higher licence fee for software with more application. they are developing innovative solutions to meet a specific business need from scratch. 8. This field can be set up to only display instruments that are current on both calibration and maintenance. The commonly cited reason is that they cannot incorporate industry-specific features into a product that is designed to be generic enough to be sold across industries. COTS are of particular interest for Laboratory Information Management Systems (LIMS). Track which instruments are used on each test . We will define customization as ANY manually written code that modifies the system behaviour while Configuration.
contract services. The objective is to minimize customization to the maximum extent possible. but the drive towards COTS is already bearing fruit. This may seem improbable. it is important to understand that in the pharmaceutical LIMS world. genomics. The significant reduction in deployment time and costs. proteomics. the real objective is not to find a panacea that will meet 100% of a company s needs. Therefore. and will continue to do so as more companies take advantage of solutions that address the majority of their business needs. there are several challenges to providing a true COTS solution to the pharmaceutical industry. it is unlikely that a system will be completely off -the-shelf.functionality. It offers
. metabalomics. Headquartered at Kolkata. Every feature that eliminates the need for custom development work provides significant savings during implementation and production use. However. it is highly unlikely that a LIMS can ever be completely. and the wide variety of reporting requirements are all areas of high variability that seemingly do not mesh well with the COTS philosophy. A typical generic solution might meet 30-40% of requirements. since there are far fewer opportunities for delay when customization is minimized. any LIMS that can provide as much as 85% of industry-specific functionality out-of-the-box will be a great boon to LIMS administrators and users. The sheer volume of tests and results that need to be supported. as well as the reduced risk associated with clearly defined pre-existing functionality can change the nature of a LIMS from an overhead expense implemented to provide regulatory compliance. Even multinational biosuppliers like Thermo Electron Corporation and Perkin-Elmer are also offering LIMS products. While the COTS philosophy has great appeal. but a good COTS solution should get you as much as 85% of the way there. pre clinical/clinical. The wide variation in requirements and workflow between companies working on small molecules or in biotech.
List of the vendors providing software in india
In India LabVantge based out of Kolkata is a serious player in this space. quality assurance. Persistent Systems and Chennai-based Agaram Industries are offering LIMS products to companies from different markets like biotechnology/ bioagri. Besides. 100 % off-the-shelf. the extensive calculations. Ocimum Biosolutions. The LIMS may not be a true COTS solution. discovery. quality management and research and development. LabVantage's solutions support the LIMS requirements of general quality manufacturing. However. Equally important. to a truly effective business solution with measurable gains in efficiency and timeliness. high-throughput discovery. quality control. In the pharmaceutical LIMS world. but the advantages are numerous. pharmaceutical/bio-pharmaceutical. differences between research and development and the production world make it virtually impossible to design a one-size-fits-all solution. different routes of administration. the reduced customization allows a pharmaceutical company to have a better grasp of the actual deployment costs and timeline. and development laboratories. rather than requiring customization to do so.
LIMS help manage the data in an integrated way and allow for the generation of reports. and Watson. the industry standard for bioanalytical labs at top 20 pharmaceutical companies. offering services to implement. processes and output. multi-user. preclinical. pharmaceutical. compare and track data from general toxicology studies like chronic. clinical and quality management endeavors. environmental and chemical industries.lims. the world's de facto standard Enterprise LIMS.com/
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http://pharmtech. Based at Hyderabad. Thermo Electron Corporation provides a laboratory informatics solution. SampleManager. long-term and teratology studies. which includes comprehensive services for planning. instruments. easy-to-use collaborative LIMS solutions to organizations in the public health. Its Sapphire R4 LIMS has solutions for the entire process .findpharma. cost-effective LIMS especially suited for pharmaceutical industry. Thermo's LIMS are designed to meet the flexibility demands of today's laboratories. petrochemical. Its LIMS offerings include. Pune-based Persistent Systems has LIMS tool that was designed to help automate the information flow part of the workflow. tracking and viewing samples. Toxchek is a pre-clinical LIMS that can manage. Biotracker is a GLP and US FDA 21 CFR Part 11 compliant Laboratory Information and Knowledge Management System. keep accurate track of samples.com/?What-is-the-Value-of-LIMS-Software-in-theLaboratory&id=3321898 http://biospectrumindia. forensics.com/pharmtech/Analytical/An-overview-of-LIMS-inthe-pharmaceuticalindustry/ArticleStandard/Article/detail/267700?contextCategoryId=39141&ref=25 http://ezinearticles. tracking of information and so on. It enables R&D and manufacturing laboratories to perform QA/QC on all inventories. training. and system validation performed by a global professional services staff. sub-acute. They are Toxchek. sub-chronic.asp http://en.ciol. LIMS enabled the user to know his current jobs. Ocimum Biosolutions has three products in LIMS space. LabVantage's Sapphire LIMS offers a variety of mechanisms for grouping. research and development.wikipedia. Pharmatracker and Biotracker. Chennai-based Agaram introduced STARLIMS in India by establishing STARLIMS (AP) Centre of Excellence.three LIMS products to meet the needs of different types of laboratories. with regulatory consulting. implementing and supporting enterprise systems.com/content/BioTrends/10511111. reagents. Pharmatracker is a multi-platform. LabVantage's Sapphire maintains a complete audit trail to comply with 21 CFR Part 11 and other FDA regulations. food & beverage. support STARLIMS clients in the AP region a nd Middle East. STARLIMS Corporation delivers cost effective.org/wiki/Laboratory_information_management_system http://www.discovery.