QUALITY DATA MANAGEMENT IS KEY TO QUALITY FOOD PRODUCTS

Today, food safety testing laboratories face numerous

scientific and operational challenges – meeting mandated

detection limits, developing sample preparation techniques

for complex matrices, increasing sample throughput, and

maximizing their return on investment. Addressing these

challenges requires innovative analytical solutions that will

enhance laboratory effectiveness.

This white paper outlines the importance of developing

a Food Safety Modernization Act (FSMA) compliance

strategy and provides a few recommendations for how to

get that effort started. It also discusses how technology

plays a key role in food safety testing laboratories, not

only to address compliance regulations, but also provides

broader business benefits, like healthier, higher-quality

products, improved customer satisfaction, and improved

business processes.

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T HE VALUE OF FSMA COMPLIANC E

The Food and Drug Administration (FDA) Food Safety

Modernization Act (FSMA) was signed into law by President

Obama on January 4, 2011. It is far-reaching legislation,

mandating a broad array of necessary changes, including new

FDA powers to recall, suspend production, and examine records.

Like the Sarbanes-Oxley Act, the Health Insurance Portability and

Accountability Act (HIPAA), and other government regulations,

the FSMA is focused on telling food manufacturers what they

need to achieve, not how to achieve it. It is up to each company

to determine how best to implement the mandates.

While much of the act is devoted, as one would expect, to food

handling, hazard controls, and other preventive measures, a closer

look reveals that FSMA is as much about data as it is about food.

Achieving FSMA compliance will be a significant undertaking for all

companies. However, if done properly, the value of compliance can

go far beyond ensuring the safety of the food we eat. It also presents

food manufacturers with a major opportunity to improve productivity,

processes, and their ability to work effectively with foreign suppliers.

Data is the key ingredient in safe food

In the broadest terms, the FSMA is focused on hazard control,

which has three components: preventing problems from occurring,

limiting the impact of problems that occur, and preventing the

recurrence of problems. The proper management of data is

essential to all three.

Specifically, the FSMA mandates that food suppliers identify

potential hazards; identify and implement controls to prevent

hazards; monitor the performance of those controls; and keep

records of that monitoring.

From a practical perspective, that means all food suppliers need

to do more frequent monitoring, more thorough testing, more

frequent inspection – and in doing so, generate massive volumes

of data, all of which must be recoded and properly maintained.

Regarding recordkeeping, the FSMA states that facility operators

“shall maintain, for not less than 2 years, records documenting

the monitoring of the preventive controls implemented...

instances of nonconformance material to food safety, the results

of testing and other appropriate means of verification... instances

when corrective actions were implemented, and the efficacy of

preventive controls and corrective actions.”

With that directive, food companies are coming to the realization

that data may be the second most important product they produce.

Vision vs. reality

Although recordkeeping procedures among food manufacturers

vary greatly from one company to the next, many still rely

on manual entry and paper-based records. There are many

disadvantages to manual, paper-based systems: they are

vulnerable to human error and difficult to share and integrate

with other systems.

Clearly, some form of computerized data management is

preferable – particularly as the volume of regulatory-related

data grows. But what kind?

Many companies already use Laboratory Information Management

Systems (LIMS) to track samples and manage quality tests in their

laboratories. LIMS offers significant value for food laboratories,

but it also has limitations when it comes to FSMA compliance.

Most notably, LIMS software typically only captures analysis

results, not the raw data from each analysis; this prevents auditors

from investigating discrepancies in final test reports, such as

when someone misrepresents results or commits outright fraud.

And while LIMS automates some processes, LIMS products still

may rely on printed records that are stored in data warehouses –

and are therefore vulnerable to human error or loss, accidental

or intentional. And if data integrity is not assured, then neither

are the results produced by that data, thereby putting regulatory

compliance at risk.

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Filling the gap

A better tool for FSMA compliance is a Scientific Data Management

System (SDMS), such as NuGenesis® SDMS. NuGenesis SDMS is the

compliance-ready data repository component of the NuGenesis Lab

Management System (which also includes the NuGenesis ELN and

NuGenesis Sample Management). In conjunction with its Connectors

feature, it serves as an automated hub where results and sample

name information can be exchanged between business system

applications like SAP or LIMS and lab systems.

SDMS software plays an essential role in the laboratory by

capturing, archiving, maintaining, and enabling the sharing of

data. Once data is captured from an analytical instrument, an

SDMS system brings instrumental data in the laboratory into the

organization’s compliance process (a set of policies defined by

the quality unit of an organization) from mass spectrometers,

chromatography instruments, NMR’s, and more.

Because it captures raw data from analytical instruments,

the SDMS solution is able to act as the single source of truth

for all data generated in the laboratory.

Moreover, an SDMS can interface with other databases, such

as Enterprise Resource Planning (ERP), Electronic Laboratory

Notebook (ELN), and LIMS.

This is vital to regulatory compliance because it maintains a data

chain-of-custody between steps in the testing and inspection

processes, thereby eliminating many opportunities for error. It

ensures data integrity and supports workflow and standardized

processes, which in turn enable easier regulatory inspection,

tracking, and auditing, as well as archiving and accreditation.

The use of an SDMS can support an FDA inspection or audit by:

■■ Capturing all analysis data at the instrument source

■■ Retaining all captured data in a compliant-ready database

■■ Enabling companies to perform queries and access

generated reports

■■ Facilitating the location of electronic records through search

allows companies to regenerate results from original data

As this list suggests, the benefits of SDMS go well beyond FSMA

compliance. The accessibility of analytical information can lead to

stronger collaboration, more efficient operations, better decision

making, and ultimately, accelerated product development and

delivery. As food companies become more global and work more

closely and frequently with global partners, SDMS can support

global collaboration and laboratory standardization, as well.

With many of the changes called for in the FSMA still undefined,

the full impact of the law will not be felt for some time. It is also

safe to assume that FSMA does not represent the end of food

safety regulatory efforts. As technologies like SDMS make it

easier for food manufacturers to manage testing data, and as

laboratory instruments become both more sensitive and more

reliable, it is possible that governments will mandate more

frequent and stringent analysis for a growing number of

analytes and contaminants. Should that happen, SDMS will be a

key enabler in the continuing fight against foodborne illness.

NuGenesis Connectors provide a direct link between the NuGenesis Lab Management System and Multi-vendor Business System Applications.

BUSINESS SYSTEM APPLICATIONS NuGENESIS LAB MANAGEMENT SYSTEM

NuGENESIS CONNECTORSSAP, LIMS,

Workflow Manager, etc.Analytical Report,

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CONCLUSION

Implementation of the FSMA is still a work in progress, as the FDA

continues to consult with stakeholders and conduct pilot programs

required in key provisions of the law. In the meantime, the agency

is carrying out other parts of the law on a regular basis.

Now is a good time for companies to begin the process of

developing their FSMA compliance strategy. Here are a few

recommendations for how to get that effort started:

1. Evaluate current processes and equipment. Before doing

anything, it’s important to take stock of how the testing

and inspection process is currently handled at all company

laboratories. That includes identifying all instruments,

computing equipment, and software now in use.

2. Understand current data flow. Because FSMA compliance

presents an opportunity to optimize the flow of data throughout

the organization, it’s also essential to track the current flow and

determine what’s working and what can be improved.

3. Assess data management and regulatory needs against

corporate business strategy and goals. If planned properly,

your FSMA compliance strategy can complement your

corporate business strategy, serving as the catalyst for needed

Multiple reports can be viewed at the same time regardless of the source application, and they are stored with automatically generated audit trails. These same reports can be linked

to the original data files from which they were created. This provides a link between the

result data, the report it came from, and the original data file created by the application.

changes and improvements. In some cases, there may be an

opportunity to reduce waste and variability in processes by

improving data management, because electronic records are

more amendable to automated compiling, and filtering for

reviewing and calculations.

4. Compile a list of SDMS requirements. Determine specific

requirements before you explore specific SDMS products. For

example, one requirement could be “must interface seamlessly

with laboratory instruments from multiple vendors.”

5. Examine the capabilities of each SDMS solution and how well

they satisfy your requirements. This will enable you to compare

solutions objectively and weigh the pros and cons of each.

As these steps suggest, your FSMA compliance effort can do

much more than just satisfy auditors and inspectors; it can deliver

broader business benefits to your company. These benefits

include: healthier, higher-quality products, improved customer

satisfaction, improved business processes, and increased agility.

The end result is safer food, but it starts with the data.

Waters Corporation 34 Maple Street Milford, MA 01757 U.S.A. T: 1 508 478 2000 F: 1 508 872 1990 www.waters.com

Waters, NuGenesis, and The Science of What’s Possible are registered trademarks of Waters Corporation. All other trademarks are the property of their respective owners.

©2015 Waters Corporation. Produced in the U.S.A. April 2015 720005272EN LM-PDF