LIMS Software - Laboratory Information System

A significant portion of an analysts time is spent in repetitive documentation both for records and audits. The drudgery puts them off. If a laboratory seriously wants to minimise such non-value adding tasks and maximise the real output, it must be equipped with an efficient, compliant yet economical Laboratory Information Management System (LIMS).

There are ever so many brands of LIMS across the world. Each one of them has its own technology and feature content and, of course, cost, complexity and constraints. It can be a daunting task to decide on a LIMS that is optimum for your laboratory, in terms of the functionalities covered, cost of acquisition and service support, the degree of regulatory compliance and the lead-time to bring visible benefits and tangible profits. Some of the issues to be considered during the LIMS selection process are discussed here to help those of you looking for a good LIMS. But the last thing first!

Quick returns on investment
Minimal customisation
You should look for a thoughtfully developed LIMS with configurable workflows. This ensures that the on-site customisation will be minimal. The commissioning and validation of the system will therefore be very fast. User-friendliness

The level of user friendliness of the LIMS you choose must motivate even not so computer-savvy users. The user interface must be encouraging with menus, screen titles, field names, messages etc. written in simple and unambiguous language. The system-to-user communication must be clear and complete. The workflow must be easy to follow so that the users can master it in almost no time.

Go live quick: A LIMS with rapid implementation and easy to master workflow, can quickly go live and start delivering returns on its investment with least gestation period.

Regulatory compliance: Your LIMS must have been designed to work in a regulatory regime, to enable strict compliance with stringent regulations under the all-important US FDAs 21 CFR Part 11 for electronic documents and electronic signatures. Your LIMS must account for a users action with his electronic signature and time and date stamp.

Audit trails: Your LIMS must keep and display audit trails for all significant and sensitive events, both security as well as workflow related. It must maintain audit trails related to records and settings, and changes made thereto, to render the electronic records authentic and tamperproof. Its audit trails should be able to display the tracked events with electronic signatures of the concerned users with time and date stamps, and the changes made, if any, to the existing records and settings.

Strict administration: For confident and demonstrable compliance the LIMS must be administered strictly. It should automatically implement the security profile as set by you. You should be able to restrict falsification attempts and idle sessions and define password attributes. The LIMS must allow access only to bona fide users but thwart unauthorised access attempts. Configurable workflow: The workflow must be role-based and the users access and functions must be controlled accordingly. The LIMS you choose must empower you to configure the workflow and define the roles. Your LIMS should be able to differentiate its users according to their defined roles.

Smooth workflow: Masters registration The main purpose of LIMS is to minimise the human effort and errors in tedious and repetitive documentation. Your LIMS must facilitate building up of Master Data of frequently used items like sample types, products, specifications, tests, business associates, instruments and other inventories etc. It must include a change control mechanism with approvals, accountability and traceability.

Sample management: Your LIMS must automatically allot a unique identification number for each registered sample, so that its allotment, analysis, approval and certification can be fully tracked. Your LIMS must have the flexibility to reassign the responsibility for individual tests (delegation) or of the whole sample (transfer). It should provide a complete trail of its journey and the persons concerned with each event. It should generate Certificates Of Analysis (COA) and ensure copy controlled printing. It should trigger a defined routine to deal with failed samples.

MIS reports: The LIMS must provide all kinds of reports to complement the Management Information System (MIS). In addition to the standard reports routinely generated and displayed, you should be able to get specific reports the content and formats of which you may define.

standard plus
value additions
Your LIMS must provide additional features or add-on modules for laboratory utilities and functions other than sample management. These may include inventory management, calibration scheduling, analyst validation, training, controlled barcode and label printing, message alerts about task arrivals and internal mail system for inter user communication.

Your LIMS should preferably be able to use its own intelligence or that of a cooperating software to directly send and get data from laboratory instruments.

Enterprisewide connectivity: If your organisation is ERP enabled, your LIMS must be able to communicate with it and freely transfer lab related information from and to it, so that you will be able to realise the extended benefits of LIMS-ERP integration, and accrue savings to your organisation on effort and expenses.

Vendor dependability: Your LIMS vendor must have the commitment and capacity to support you as a customer and his product, both before and after the sale, and long after. He should provide assistance during validation if you so opt. It is desirable that your vendor is within easy reach for assured support, say right from your city or at least from within your country, so that the service could be fast and the costs would be affordable. The product as well as service from far away countries with scarce local representation can be both inconvenient and expensive.

User training: Your LIMS vendor must also be able to provide a focused training and training aids and materials so that your staff will make a quick job of learning its operation. Survey before you select Learn from others. You must not hesitate to make discrete enquiries to know who in your neighbourhood are using what LIMS at what cost and what their experiences have been with regard to the quality of the product as well as support services.

Well begun is half done. Begin your search with objectivity and you will be assured of an optimum solution. It is hoped that the above tips would help in making a good and objective choice of a LIMS for your laboratory. The care you exercise in deciding on the right LIMS will pay itself off within a short time after you - go live on it. Go, get it!

The writer is director, Calibre Technologies Pvt Ltd

Source: http://www.expresspharmapulse.com/20040805/technologytrendz01.shtml

1. “How (and how not) to Buy a LIMS Guide” By Autoscribe UK Ltd.

Choosing the right LIMS

1. “How (and how not) to Buy a LIMS Guide” By Autoscribe UK Ltd.

Chances are that you know someone whose LIMS system is not working in the way that they wanted it to.

How to buy a LIMS that delivers any screen anywhere, anytime, on the web or on familiar windows clients.

A LIMS that has a track record of 16 years of upgradeability, backward compatibility, is modern (.NET, IIS, C##) and has NO dead or legacy code.

A LIMS that is Designed for Change and can be easily configured once for web and for windows as often as your business needs require. So you will not join the club of 50% or greater LIMS failures. A successful LIMS that can be fully implemented and configured in less than a month. Smaller systems in just a few days.

A LIMS that is easily scaleable from a single user to the Enterprise.

A LIMS that is easy to use because ALL of the screens work completely the way that you and your customers do.

A LIMS that is implemented without programming, coding or the use of external consultants.

In order to assess your specific needs for a LIMS, in a cost effective and an efficient manner, you can request our free “How (and how not) to Buy a LIMS Guide”. Request your free copy now by contacting:

Autoscribe UK Ltd.
Wellington House
Riseley Business Park
Basingstoke Road
Riseley
Reading
Berkshire
RG7 1NW
UK
Telephone: +44 (0) 118 984 0610
Fax: +44 (0) 118 984 0611
Email: matrix@autoscribe.co.uk

Autoscribe - The Winning Formula!

About Autoscribe

Autoscribe Limited is a world leader in the development and supply of successful software solutions for LIMS (Laboratory Information Management Systems) and the scientific laboratory and business markets.

Autoscribe pioneered the use of innovative configuration tools within the LIMS market and today our Matrix Plus LIMS software is seen as the industry standard to which others aspire.

Autoscribe offers a wide portfolio of products and services including systems for LIMS, sample tracking, instrument calibration and maintenance, stability testing, customer complaints management, ISO9000 protocol driven training records management and resource planning. Our customers include leading analytical, oil, pharmaceutical, biotechnology, chemical, and consumer products companies as well as academic research institutes, hospitals and many others.

Founded in 1981, Autoscribe is a privately owned UK company. Worldwide we are represented by a network of business partners in regions including the USA, Canada, France, Benelux, Germany, Indonesia, Switzerland, Scandinavia and Australia. Our organisation includes a dedicated team of developers, technical support specialists and sales & marketing professionals.

For more information, see Autoscribe on the worldwide web at:

http://www.autoscribe.co.uk/