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Traditional Laboratory Information Management System (LIMS) implementations are notorious

for keeping people awake at night. Industry analysts like Strategic Directions and ARC Advisory

Group have estimated the failure rate of commercial LIMS solutions to be as high as 60 percent

with many of them failing to deliver original customer requirements after lengthy and expensive

deployments. Gartner has also taken a deep dive into the LIMS vortex and reported back that many

LIMS engagements come with “bloated costs, poor ROI and excessive effort to make LIMS work for

current business processes… they all require a different level of back-end customization and effort,”

and “most LIMS vendors oversell what they can confidently deliver.” 1

Sleep-disturbing LIMS issues include sample-centric technology that inhibits your ability to manage

change and organizational complexities, minimal “out-of-the-box” implementation, little integration

with lab environment and other IT systems, excessive custom coding required before validation in

your cGMP environment, lengthy implementation times and high ongoing total cost of ownership

If you find yourself waking in a cold sweat, your mind racing with any of the following common

LIMS nightmares, you are not alone. Fortunately, there are technology answers to these bad dreams

that can help you rest easier.

“What happened – my LImS ImpLementatIon coSt 2-3 tImeS more than expected?”

Scope creep and customization wreak havoc with LIMS costs and schedules. The typical initial

cost of a LIMS implementation can exceed $100,000 to $1 million and traditional global LIMS

deployments can extend beyond 5 years and cost over $5 million ($1 million/year). Many LIMS

vendors say they can custom code whatever you need into your system including electronic lab

notebook and lab execution system functionality. With enough dollars and enough time, they can

probably do this, but then, if you’re operating in a compliant environment, you have to validate all

that custom coding and configuration. This can mean a big new line item in your budget and a

lengthy deployment delay.

Instead of this, look for a flexible, “out-of-the-box” LIMS that provides the functionality and

integration you need with no custom coding. A European pharmaceutical company, after pouring

years and millions of dollars into unsuccessful attempts to custom-code a lab execution system

(LES) into an existing LIMS, finally opted instead for a purpose-built LES that integrated with the

LIMS and was up and running in 6 months. This approach saved the company $2 million/yr. and

achieved positive ROI in one year. The same implementation scenario can also work for a full LIMS

deployment designed to track and trace materials, samples, instruments, specifications, reports and

data transfers from lab to plant.

hoW to avoId the top 5 LImS nIghtmareS

1 Gartner Research Report G00229637, revised August 7, 2012, Mike Shanler

How to Avoid tHe top 5 LiMS NigHtMAreS

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“hoW many peopLe do I need to get thIS thIng done? I’ve had 13 peopLe, 5 dayS a Week… and four yearS Later my LImS StILL ISn’t fuLLy depLoyed.”

A large, well-known biotechnology company struggled with this nightmare. They

found themselves with 13 fulltime headcounts on site 5 days/week, all of them fully

engaged in a traditional LIMS deployment that had been going on for four years with

no end in sight. The resources included a Citrix Administrator… an Oracle Database

Administrator… a LIMS Consultant… Validation Consultants…and the list went on. The

greater part of the workload for all these individuals related to system customization

and documentation/instrumentation integration tasks coupled to core LIMS

functionality.

You can avoid this kind of “personnel creep” by steering clear of traditional LIMS and

LIMS applications/modules that require labor-intensive custom programming and

consulting. By doing this, you will also accelerate deployment and validation, lower

total cost of ownership and increase ROI. You might also want to consider a LIMS

built on a scientifically aware informatics platform that enables integration with lab

instrumentation and existing IT systems like legacy LIMS and ERP implementations.

An underlying informatics platform such as this can also streamline data exchange,

aggregation, analytics and reporting along the lab-to-plant continuum.

“do I reaLLy have to create my entIre vaLIdatIon package?”

Many organizations stretch their traditional LIMS capabilities beyond what they were

originally designed to deliver by creating modules that then have to be painstakingly

pieced together to provide the functionality and workflow management needed. This

custom add-on functionality can actually degrade core functionality or earlier coded-in

modifications, but, more importantly, it also adds significant validation cost. Creating

validation protocols that satisfy FDA scrutiny is a time-consuming, manual effort usually

involving expensive outside consultants and validation experts. It can take weeks to

write the scripts and weeks to run them, and every little change requires validation.

Look for a LIMS that automatically creates the qualification/validation documentation

based on industry-standard best practices without the need for vendor or third-party

validation resources. As you build your LIMS application, the system simultaneously

creates the necessary qualification/validation packages, accelerating your LIMS

deployment in a regulated environment.

They found themselves with 13 fulltime

headcounts on site 5 days/week , all of

them fully engaged in a traditional LIMS

deployment that had been going on for

four years with no end in sight.

Many organizations stretch their

traditional LIMS capabilities beyond

what they were originally designed

to deliver . . .

How to Avoid tHe top 5 LiMS NigHtMAreS

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The writing of custom code can turn

your LIMS implementation into an

ongoing nightmare “project” instead

of the simple “product” purchase

you anticipated.

. . . every time you tweak the system, you

have to revalidate because changing

code in one place can break something

somewhere else.

“and you SaId thIS WaS commercIaL, off-the-SheLf?”

Most LIMS vendors tout their systems as COTS today or state that they are heading in

the COTS direction. However, in the real world, building and deploying a traditional

LIMS typically requires writing and painstakingly piecing together code to match the

LIMS framework of your specific business framework. For example, workflow definition

(result entry, rework loops, etc.) and data migration typically involve significant

customization. Custom code can turn your LIMS implementation into an ongoing

nightmare “project” instead of the simple “product” purchase you anticipated.

Today innovative companies have the option of selectively deploying truly off-the-

shelf commercial applications for environmental monitoring, inventory, metrology/

calibration, sample, stability and work request management. This next- generation

LIMS also includes powerful electronic lab notebook, lab execution system, electronic

batch record and process management informatics capabilities—all built on a single

underpinning informatics platform that handles data aggregation, analysis and

reporting and integration with other IT systems. This new “more than LIMS” approach

requires no custom coding, provides automatic qualification/validation and enables fast

deployment in only a few months as opposed to the years it can take with traditional

LIMS deployments.

“heLp – my BuSIneSS WorkfLoWS have changed, But I can’t change my LImS WIthout programmerS and vaLIdatIon ScrIptS.”

With traditional LIMS deployments, an army of support people must constantly

deal with shifting workflows and priorities. Processes change; new capabilities and

procedures are continually being added, subtracted or revised. And every time you

tweak the system, you have to revalidate because changing code in one place can

break something somewhere else.

Instead chose a flexible, next-generation LIMS with automated compliance and

qualification/validation built into the core technology. Even better, you won’t need that

crowd of outside consultants, programmers and validation experts. Your system can be

deployed and operating in less than two months using your own in-house resources

supported by a single vendor with a proven track record. You’ll rest easier.

To learn more about today’s next-generation, process and execution-centric LIMS,

please visit accelrys.com/lims