Choosing a laboratory informatics solution has long-term implications and is an important decision for any organization. LabWare’s products have been proven in a wide range of industries over a period of more than 30 years. Our sole focus is laboratory informatics and we develop, market, and support a single well planned suite of products. At the forefront of our Enterprise Laboratory Platform (ELP) are our flagship products, LabWare LIMS (Laboratory Information Management System) and LabWare ELN (Electronic Laboratory Notebook).
LabWare has never pursued an acquisition based growth strategy, and so our solutions have evolved according to a deliberate roadmap. LabWare is a privately owned, stable, and financially strong company with an extensive global product delivery and support infrastructure. Our global team includes the most experienced laboratory informatics professionals in the world.
The worldwide headquarters for LabWare is in Wilmington, Delaware, U.S.A., and all research and development activities take place at this location. LabWare has invested in establishing sales and support facilities around the world to provide the best possible support to our customers in over 90 countries. LabWare employees have an average of 10+ years of industry experience, and many with more than 15+ years. The total base of experience across our company exceeds 2200 man years. We bring together the talents of chemists and biologists with those of engineers and software experts to develop products focused keenly on the needs of laboratory users. Whereas other suppliers struggle to keep up with the burdens imposed by multiple overlapping and redundant applications, LabWare provides software solutions for all types of labs in an easily configured common platform.
Two principles stand out when understanding LabWare's philosophy for developing their Laboratory Information Management System (LIMS) product. The first and overriding principle is that, whatever needs to be achieved, it must be configurable rather than customized by whoever needs to implement it. Let us take a moment to understand what this means:
Configuration implies the use of standard tools and mechanisms within the product to accomplish a desired effect. This will involve the use of templates and may indeed require that a scripting language be invoked (in LabWare LIMS this language is called LIMS Basic). This scripting language generally allows the user to call standard functions within the application, and these functions will necessarily behave in a predictable and correct manner. For example, logging a sample into LabWare LIMS using a LIMS Basic function will have exactly the same effect as logging the sample via one of the login screens. The audit trail will be produced, any configured triggers and rules will take place and all security features configured will be used.
The alternative to configuration is customization. Typically this involves using software tools, often the ones used to develop the core product in the first place, to alter the application to suit the situation at each site. This approach has several potential dangers. The behavior of the customized code may not be the same as that of the original code and, especially if the person performing the customization does not completely understand the inner workings of the product, it probably will not be. With customization it is easy to bypass certain security that should be adhered to (this is particularly serious for regulated or accredited labs). Using customized code also runs the risk of preventing or at least complicating future upgrades.
The other principle that is religiously followed by LabWare is that all enhancements are ultimately driven by the needs of the customers either articulated directly, or indirectly via the consultants working with the customers. So LabWare is continuously developing the tools and modules to satisfy the ongoing needs of the customers, but doing it in a way that adheres to the first principle, i.e., everything is built to be configurable and to be generic, so that all the customers can benefit from improvements and advancements asked for by specific customers.
LabWare’s customers are dedicated, engaged, and contribute greatly to evolution of the product. Since LabWare LIMS is configuration driven and includes all functionality in the base product, our customers can relate to each other from a common point of reference. This philosophy of transparency, with free flow of knowledge, truly empowers users, and makes them part of a global community. LabWare encourages collaboration and information sharing amongst the customer base via Customer Education Conferences, training sessions, and the LabWare LIMS online discussion group.
Our philosophy is to provide seamless interfaces to our partners' IT solutions so our customers can focus on their business. Industry feedback clearly sends the message that customers prefer 'best-of-breed' products. Single vendor solutions have too many compromises for most users. LabWare believes in the 'best-of-breed' philosophy, and further believes we must be responsible for interoperability with the leading industry solutions.
LabWare has a strategic partnership with the following industry leaders. We have worked closely with each of these partners to build a bi-directional interface between LabWare LIMS & ELN and our partner's complementary product.
Purpose: The purpose of this statement is to establish LabWare’s position regarding compliance of LabWare LIMS and LabWare ELN with its specification and generally accepted practices for ownership of GXP or Validated software products.
Statement: LabWare LIMS and LabWare ELN are intended for use in regulated laboratories. Our QA process are designed to ensure compliance with its specification and to be consistent with the principles outlined by GLP, GALP, cGMP, and ISO. LabWare LIMS and LabWare ELN are designed in accordance with GAMP and ISO 9001:2000 guidelines and operates in such a way that:
- allows configuration instead of programmed customizations;
- contains internal configuration-change-control auditors;
- all raw data modifications are audited;
- configuration can be centrally maintained;
- permits language and terminology translations without compiling source code;
- supports database configuration changes without compiling source code;
- conforms to the requirements for a 'Closed System' as defined by 21 CFR Part 11;
- GAMP 5 Guidelines define as a 'Category 4 - Configurable Software Package',
Development of LabWare LIMS and LabWare ELN uses a fully documented Spiral Life-Cycle development methodology. LabWare’s Quality System consists of Standard Operating Procedures (SOPs) governing the entire development life cycle and on-line systems that control and document all software changes. The Quality System is continuously being improved and is audited extensively by LabWare’s customers and our internal ISO trained auditor.
LabWare LIMS and LabWare ELN are extensively tested prior to each software release. Formal Test Plans and Scripts are utilized. A 'traceability matrix' is used to cross-reference functional requirements to user documentation and test plans. An external validation consultant reviews executed scripts and signs off on the release to assure that the system does what it purports to do.
Every version of LabWare LIMS and LabWare ELN has been audited by numerous companies against ISO and GAMP guidelines. No company has decided not to purchase the software because of validation concerns. In addition, no LabWare customer has been unable to validate the installed system.
LabWare is open to audits by any customer or regulatory agency, and all Quality System documentation is available for inspection and review.
LabWare LIMS Quality Statement
Purpose: The purpose of this statement is to establish LabWare's position regarding the compliance of LabWare LIMS with generally accepted practices for development of GXP or Validated software products.
Statement: LabWare LIMS is intended for use in regulated laboratories and is consistent with the principles outlined by GLP, GALP, cGMP, and ISO 9000. LabWare LIMS is designed in accordance with GAMP and ISO 9000-3 guidelines and operates in such a way that:
- Allows configuration instead of programmed customizations;
- Contains internal configuration-change-control auditors;
- All raw data modifications are audited;
- Configuration can be centrally maintained;
- Permits language and terminology translations without compiling source code;
- Supports database configuration changes without compiling source code;
- Conforms to the requirements for a 'closed system' as defined by 21 cfr part 11;
- GAMP 3 Guidelines define as a 'Category 4 - Configurable Software Package'.
Development of LabWare LIMS uses a fully documented Spiral Life Cycle development methodology. LabWare's Quality System consists of Standard Operating Procedures (SOPs) governing the entire development life cycle and on-line systems that control and document all software changes. The Quality System is continuously being improved and is audited extensively by LabWare's customers and our internal ISO trained auditor.
LabWare LIMS is extensively tested prior to each software release. Formal Test Plans and Scripts are utilized. A 'traceability matrix' is used to cross-reference functional requirements to user documentation and test plans. An external validation consultant executes the scripts and signs off on the release to assure that the system does what it purports to do.
Every version of LabWare LIMS has been audited by numerous companies against ISO and GAMP guidelines. There have been no significant findings, and no company has ever not purchased the software because of validation concerns. In addition, no LabWare customer has been unable to validate the installed system.
LabWare is open to audits by any customer or regulatory agency, and all Quality System documentation is available for inspection and review.
The LabWare Advantage is success-- those things that have made our customers successful in their LIMS implementations, the things that have provided the most functionality, flexibility, supportability-- in short, the most value in the industry.
These are the things that distinguish LabWare and LabWare LIMS.
Look for the LabWare Advantage mark throughout our extensive product, services and technology offerings on this web site.
- 97% of our customers recommend LabWare LIMS to a Colleague Reference SDI 2005
- Configure Once, Deploy Anywhere
- Most recognized and awarded LIMS Reference Scientific Computing and Instrumentation Reader's Choice Award 2000-2007
- 67 countries... worldwide coverage
- No customer left behind. Our first customer is still a customer today!
- Your platform choice….NOT ours!
- Market Momentum - more people choosing LIMS are choosing LabWare LIMS Reference 2004-07 new customer lists
- One Product does it all
- Customer Centric - we are an independent company. Our customers determine our direction
- Results Count!
In the recent Strategic Directions International (SDi) survey, LabWare scored the highest of all LIMS vendors on the subject of which company provides the best value for the money. LabWare believes that our all-inclusive license strategy is one reason the LIMS market sees us as providing the most value.
LabWare LIMS is a single product offering covering multiple industries and multiple disciplines. LabWare believes there is no efficiency from a vendor’s perspective or a customer’s perspective to support multiple LIMS products from the same vendor. Two disadvantages of a multi-product or point solution approach are:
- The overhead of incorporating hundreds if not thousands of similar features in each LIMS product has a negative impact on the vendor’s ability to extend their product functionality
- Configuration and testing efforts are not efficient
LabWare LIMS offers Optional Modules to address industry and discipline specific requirements. Once installed, an Optional Module is fully integrated into LabWare LIMS and incorporates all the benefits of the underlying architecture and configuration options.
Most enterprise applications follow a traditional model of developing new functions and delivering them as a new version. LabWare is different. We develop in a modular fashion and make each functional module available to our entire customer base throughout its development lifecycle and upon QA release.
Our customers don’t have to wait for the next release to take advantage of our product development—they participate in the development process and can use new modules immediately. This means more out-of-the-box functionality today and ensures even more functionality tomorrow.
LabWare’s product release model is closely linked to its quality system that consists of standard operating procedures governing the entire development lifecycle and which includes online systems that control and document all software changes. LabWare LIMS is extensively tested prior to each software release utilizing formal test plans and scripts. A traceability matrix is used to cross reference functional requirements and capabilities to user documentation, functional specifications, and test plans. To add further assurance that the software performs as expected and documented, LabWare engages an external validation consultant to execute the test plans and to sign off on the software quality prior to release. All LabWare products are released only when the external validation company certifies that all test cases have tested successfully, and that everything essential to product release is complete.
Goal Oriented LIMS Delivery
Based on work with hundreds of successful LIMS projects, LabWare has developed a remarkably successful and proven implementation methodology that we call “Goal Oriented LIMS Delivery” (GOLD). GOLD takes the best ideas from the IT industry and applies them to LIMS implementation. The methodology embraces effective project management techniques that fully utilize an evolutionary, participatory approach while maintaining tight time scales and regulatory compliance.
GOLD encourages customers to adopt a phased approach to their implementation. Phasing the deployment of the overall project scope results in a quick return on nvestment (ROI) and has the added benefit of the implementation team learning from experience.
- LabWare believes there are three key differentiators within the LabWare Gold Methodology:
LabWare uses an iterative approach to functional design
Commercial Off-the-Shelf (COTS) software products require the users to interact with the system to understand what functions and features are available. The LIMS team configures and then evaluates LabWare LIMS in an iterative manner in order to select the solution that is most appropriate.
The classical waterfall model of writing detailed requirements before interacting with the COTS software product is inappropriate.
- All LabWare services are done on-site
LabWare consulting services are, for the most part, done at a customer’s facility. This provides several advantages.
- The customer develops a rapport with the consultant leading the consultant to better understand the goals and objectives associated with the project
- The customer can better monitor the progress being made by the consultant
- Overall communication is more efficient with on-site access to the consultant
- Mentoring the customer’s LIMS team is encouraged
LabWare customers are encouraged to participate in the configuration of LabWare LIMS. To facilitate this objective, consultants are instructed to mentor a customer’s LIMS team.
LabWare strongly believes that it is in the customer’s best interest to be able to support their LIMS implementation themselves. A key factor to long-term success with LIMS is by having an organization that is self reliant and knowledgeable at keeping their LIMS up to date with respect to their changing business environment. Our entire business model is to develop superior yet customer-friendly LIMS solutions and to teach our customers how they can use those solutions effectively without requiring an unnecessary reliance on LabWare.