Abstract
While laboratory tests are an important part of Environmental Monitoring (EM)operations, the EM workflow is complex and the EM workplace presents aunique set of challenges. Commercial Off-The-Shelf (COTS) LIMS products
bring a wide range of functions to help automate the analytical laboratory, but
struggle to meet the unique challenges of the EM operation.
This paper reviews the workflow typically found in EM operations to identify
the needs of the EM organization. It matches the capabilities of commercial
LIMS to these needs, and discusses the LIMS customizations that would berequired to close these gaps. It also discusses two alternative approaches tobuilding an interface between an EM-specific product, such as MODA-EM,
and a commercial LIMS.

The Environmental Monitoring Workflow
Figure 1 describes the EM workflow in six stages.

Figure 1. Environmental Monitoring Workflow
The following table briefly describes each of these stages and discusses the LIMS productcapabilities that could be used to support the stage. It identifies the limitations of the LIMS
and lists the customizations that would have to be performed.

White PaperThe Gap Between LIMS Capabilities andEnvironmental Monitoring Needs

White Paper - The Gap Between LIMS Capabilities and Environmental Monitoring Needs

EM Workflow Stage

LIMS Product Capabilities and Limitations

Establish the sampling
requirements for a clean roomor suite. Identify the test
protocols, sampling sites andfrequency of monitoring needed to comply
with clean room standards, operational procedures, and validation criteria.

• Some LIMS products provide a Storage Location
Management module that is designed to track thelocation of a sample once it has been collected. But
this function typically does not allow association oftests, test variants or specifications with a storage
location.
• Some LIMS products include a Scheduling module
for sample collection. But these functions are
typically based on production schedules. They lackthe ability to easily manage sampling for multiple
locations with multiple test protocols for multiple
frequencies – a concept that is central to thescheduling of dynamic and static EM sampling.

Establish a schedule to conduct the EM work
– sampling and testing – that will meet theseneeds.

Customization required to extend the “Storage”
and “Scheduling” functions of the LIMS.
Choose EM work from today’s
plan and assign it to microbiologists for execution.

• Most LIMS products have no concept of dividing
planned work among samplers – they simply
produce a list of samples to be collected.

Organize each person’s assignments according
to facility layouts (e.g., in the aseptic core) andtheir capabilities and training.

Customization required to create and manage
assignment lists for individual microbiologists.

Adjust assignments among microbiologists tobalance workload during each shift.
Working in a clean room,
move from site to site tocollect samples and perform
tests. Use a sanitized, mobile,touch-screen computer to support paperless
operation by gowned and gloved microbiologists. Operate with limited network connectivity, if necessary.

• LIMS are generally designed for fixed-basecomputers communicating with fixed lab
instruments in a lab, not in a clean room. Sites andequipment are not typically available for fast data
capture as samples are taken, but scheduled inadvance.
• Sample labels are typically pre-printed in accordancewith the schedule. As a result, non-routine samples
and process mistakes require leaving the samplingsite to reschedule samples or reprint labels.

On sterile label stock, print a label for eachsample containing identification number
encoded in a barcode, collection time,sampler and protocol information. In addition,
read barcodes on sites and equipment (e.g.,non-viable air sampler) to quickly identify
scheduled tasks and assure valid use ofequipment.

Customize to port LIMS to specialized hardware
and touch-screen user interface. Add function for
capturing information at the time of samplingversus in advance of the shift.
• LIMS products do not associate samples with anindividual, as is required for a personnel sample.

For personnel samples, generate the samples
needed based upon the people in the roomat the time of sampling and the sites (e.g.,glove and gown) to be sampled. Record theidentity of the individual from whom thesample was taken.

Customize to add sample generation as needed
based upon dynamic conditions and capture
personnel identity and gown/glove sites withsamples.

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EM Workflow Stage

LIMS Product Capabilities and Limitations

Returning to the microbiology
lab, check-in the samples thathave been collected. Placeplates in an incubator andremind microbiologist when samples areready for reading. Alert the user when incubation time is about to exceed the SOP limit.

• LIMS products generally provide these functions,but generally do not alert the user when an event
occurs that will violate the SOP.

For plates with non-zero counts, identify
organisms that appear in samples. Record
the process that was employed to identify
the organism (e.g., a ViTek analyzer).
View a list of unapproved
results. Revisit test results.
Assign batch/lot information
to samples, if not done soalready. Approve results.
Generate alerts and actions for out-of-range
results and for trends, such as three consecutive
non-zero counts.

Filter database of approved
results to select data ofinterest. Typical filter criteria
show results for:• A specific batch/lot, to support batch closeout.

• Some nuances of EM workflow, such as multiple
incubations and organism identification, are notsupported by COTS LIMS.
Customize to support unique workflow, SOP
deviation alerts, organism taxonomy andorganism identification.

• LIMS products generally provide these functions.
• Most LIMS products provide alert and action
notifications, but may not support the ability tospecify alert and action limits by the intersection ofsample location (such as a room site or a personnelsite) and test protocol. Most also do not support
notification on the basis of trend recognition.
Customize to support EM-specific alert andaction limits and trend recognition.
• While LIMS products provide many reports, they do
not provide EM-specific reports and do not allow
filtering and grouping of these reports based upontypical EM-specific analysis scenarios.
Customize to produce EM reports.

• A specific room and time period, to identify
excursions and support investigations.
• A specific microbiologist, to review trainingefficacy.
• A specific media lot, to review sterility
assurance.
Produce reports to show EM excursions andtrending. Export results to Excel for further
analysis and reporting.

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White Paper - The Gap Between LIMS Capabilities and Environmental Monitoring Needs

In summary, most LIMS products do not provide specific capabilities and features that arerequired to support Environmental Monitoring:• Not paperless. LIMS products are not designed to eliminate paperwork, but rely onlists of tasks printed in advance for sample collection. Process deviations andunscheduled events not anticipated by LIMS require even more paperwork.
• Inadequate workflow. LIMS products are not designed to support the location, routine
and event-based scheduling functions that are essential to support EM SOPs forclean rooms.
• No clean room platform. LIMS products are not designed to operate on sanitized,
mobile, touch-screen PCs with limited network connectivity. They typically use fixedworkstations.
• Inadequate reports. LIMS products do not include the analysis tools to study thetrending, perform the investigations and produce the reports to meet core EM needs.
And once the extensive customizations for EM are complete, the standard functions may nolonger work for the routine, non-EM storage and scheduling functions of the lab.

Alternative Approaches
Environmental Monitoring is usually performed by a Microbiology group that is part of a Quality
Control (QC) department within the manufacturing organization. The LIMS product underconsideration for EM may have already been adopted by the QC or Quality Assurance (QA)
department to control other laboratory functions, such as analytical chemistry.
Even though the LIMS may not be a natural solution for the EM process, it is possible to extend
LIMS functionality to meet the EM requirements. This whitepaper will describe two viable, alternative
approaches:• Deliver results - Choose an EM-specific product, such as MODA-EM, that meets the needs ofthe Microbiology group and integrate with the LIMS only to report the results of the EM
process for compliance activities such as product release.
• Tight integration - Choose the same EM-specific product and “tightly connect” it to the LIMSproduct.
The following sections describe these approaches.

Deliver Results
This approach leaves the entire EM workflow in the EM-specific product. The EM systemcommunicates with the LIMS at two points in the process:• For the EM system to obtain batch/lot information from the LIMS. The EM systemassociates this information with each sample so that later EM reporting can be doneon the batch/lot.
• The EM system delivers approved results to the LIMS product. This places all QC
information in a single system of record – the LIMS.
This flow of control and information is depicted in Figure 2.

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Figure 2. Deliver results from EM to LIMS

Advantages of Deliver Results Approach• The LIMS system eventually receives all completed EM results; there is a single repository
for all QC data.
• The EM workflow is supported by an EM-specific product.
• LIMS customizations are not necessary for EM.
• Common LIMS platform provided for both QA and QC data.
• Ability to report from LIMS on combined QA and QC data for product/batch release.

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White Paper - The Gap Between LIMS Capabilities and Environmental Monitoring Needs

Tight Integration
This approach describes an example of how an EM-specific product can be tightly integrated to a
LIMS product. It divides the EM workflow between the two systems:• A Microbiology Supervisor schedules sampling using the LIMS Scheduling function, whichbuilds a list of the planned samples to be collected.
• This schedule is exported to the EM system, where it becomes one or more Assignment Lists
to be performed by microbiologists.
• The EM system, operating in the Clean Room, supports the Microbiologists as they process theAssignment Lists and collect samples.
• When the samples arrive at the Microbiology Lab, the EM system exports information about
them to the LIMS, matching samples to the original LIMS schedule.
• The LIMS supports processing of samples, including incubation and results entry.
• The LIMS supports review and approve of the results.
• The EM system accesses the LIMS database to produce EM-specific reports.

This flow of control and information is depicted in Figure 3.

Figure 3. Example of Tight Integration Between LIMS and EM6

Advantages of Tight Integration Approach• The LIMS holds all EM results; there is a single repository for all QC data.
• The LIMS is able to track all scheduled, in-progress EM work.
• The mobile capabilities of the EM Collect Samples function are employed.
• The workflow capabilities of the LIMS Process Samples and Review Results functions areemployed. This is consistent with the processing of non-EM tests elsewhere in the QC
organization.
• Common LIMS platform provided for both QA and QC data.
• Ability to report from LIMS on combined QA and QC data for product/batch release.

Conclusion
By itself, a LIMS is not a viable solution for support of an EM workflow. The LIMS is designed for anenvironment in which production-based samples are brought to fixed instruments in a lab. The EM
process involves complex planning of sample collection at sites whose physical location is essential
information – simply a different problem. As a result, a LIMS would require extensive customization toeffectively support the EM workflow.
The Deliver Results option is very straightforward and can quickly enable an organization to effectively
address their EM-specific requirements for sample scheduling and collection via an automated, paperless
EM solution like MODA-EM; while leveraging a LIMS for viewing, management and additional reporting of
all completed QC records.
The Tight Integration option between a LIMS and an EM-specific product is more complex, but alsofeasible. A key additional advantage of this option is the establishment of single, common repository
for all QA and QC data, including the work in progress. Tighter integration wrapped in a product offering
along with a single line of product support provides even more value to the Information Technology(IT) groups responsible for maintaining the solution. A leading commercial LIMS vendor has recently
established a formal partnership with MODA Technology Partners to provide a tight integration withMODA-EM as a commercial-off-the shelf (COTS) hardware and software extension to their LIMS productline. The integrated solution has been fielded in production biopharmaceutical manufacturing environments
and is receiving very favorable market interest, thus providing real-world field validation to the concepts
raised in this whitepaper.

7About MODA Technology Partners
MODA Technology Partners (MODA) is a commercial software company whose primary
focus is addressing the growing need for effective automation and efficient regulatorycompliance within pharmaceutical manufacturing. MODA's software leverages mobile
computing technology to help their clients increase operational efficiency, improve quality
and reduce manufacturing costs. Additional information is available on the web atwww.modatp.com.

MODA Technology Partners, Inc.

www.modatp.com

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