Commitment to quality and compliance

The Dietary Supplement Health and Education Act of 1994 (DSHEA) specifies that dietary supplement manufacturers are responsible for ensuring their products are safe before they are marketed. The FDA regulates both finished dietary supplement products and dietary ingredients. Under 21 CFR Part 111, dietary supplement manufacturers must comply with current Good Manufacturing Practices (cGMPs).

Manufacturers must also act in accordance with 21 CFR Part 11, which specifies guidelines for data management, including the storage and protection of electronic records, and the application of electronic signatures. The purpose of these guidelines is to ensure the security, integrity and traceability of electronic records, including data, analytical reports and other records associated with the operation of analytical instruments.

At the forefront of quality and compliance in the dietary supplement industry, 4Life has outfitted its quality control operations with state-of-the-art analytical systems that provide the capabilities necessary to meet these regulatory requirements. In particular, Agilent OpenLAB Enterprise Content Manager (ECM) and Electronic Lab Notebook (ELN) provide the features needed to retain data and information according to the requirements of 21 CFR Part 11: secure content storage, audit trail, and e-signature.

Customer Profile:4Life Research

AGILENT OPENLAB ECM AND OPENLAB ELN

“ We take quality seriously. The company is committed to investing in technologies that not only provide a benefit from a regulatory standpoint, but that also ensure we are ahead in product quality. For this reason, our quality control labs are the most advanced in our industry.”

DAVID VOLLMER, SENIOR DIRECTOR, QUALITY CONTROL, 4LIFE RESEARCH

4Life Research facility

Headquartered in Sandy, Utah, 4Life Research is a leading dietary supplement manufacturer with offices in 23 countries on five continents to serve a global network of independent distributors. Thousands of people in more than 50 countries enjoy the immune system support of 4Life products. The company’s Transferceutical™ Science encompasses research, technology, and product innovation.

Integrated OpenLAB solution keeps 4Life Research at the forefront of quality and compliance

The situation

4Life’s quality control lab tests all incoming raw materials and final products for identity, strength, purity and composition. These tests are used to guarantee the company’s products contain the right components in the correct amounts. Analytical tools from many different vendors--from more sophisticated LC, ICP-MS, and FTIR systems, to routine pH meters and balances--are used.

To ensure 21 CFR Part 11 compliance, all data generated by these tests must be securely stored with controlled access, version control, audit trail, and e-signature. Being prepared for audits is another important aspect of compliance. Audit readiness includes the ability to retrieve data and trace its history back to its original collection in raw form, quickly and easily.

Integrated OpenLAB solution

Both OpenLAB ECM and OpenLAB ELN provide 4Life with the capabilities needed to retain raw data and results according to 21 CFR Part 11: secure content storage, audit trail, e-signature, and version control. All changes are recorded in user-independent time-stamped audit trails. Because data and results are organized and easy to retrieve in either software, 4Life is ready for an audit.

A scientific data management system (SDMS), OpenLAB ECM is the secure repository for raw data produced by the Agilent LC and ICP-MS systems as well as the non-Agilent systems. Data are automatically uploaded to ECM from the Agilent OpenLAB CDS and MassHunter workstation software at the end of every analytical run. Any data and document captured as an electronic record in OpenLAB ECM is automatically indexed, allowing its rapid retrieval.

An electronic lab notebook, OpenLAB ELN is used to capture final results for tracking and reporting purposes. The two software applications are tightly integrated. After entering a user name and password, the user can open OpenLAB ECM within OpenLAB ELN. This enables the user to pull data such as spectra into OpenLAB ELN easily. Likewise, raw data stored in OpenLAB ECM can be hyperlinked to an OpenLAB ELN experiment, enabling fast retrieval.

“ Being prepared for audits is a key part of our compliance goals. Because we are under the cGMP regulations, we have the potential to be audited by the FDA. If an FDA auditor has a question about a product or a test, we have to be able to retrieve that test data and demonstrate that it hasn’t been manipulated—that it is traceable all the way back to its rawest form.” DAVID VOLLMER, SENIOR DIRECTOR, QUALITY CONTROL, 4LIFE RESEARCH

“ OpenLAB ECM and ELN enable us to fulfill our compliance requirements. From the moment we generate data, it’s in a secure repository where if we make any changes, those changes are noted, validated, and signed off so we have traceability throughout the whole process, until we actually report it.” DAVID VOLLMER, SENIOR DIRECTOR, QUALITY CONTROL, 4LIFE RESEARCH

4Life Research laboratory

“ The benefit to our customers is that we can use OpenLAB ELN to evaluate our historical data to set the proper raw material or finished product specifications so that in the end, they always get a consistent product.” DAVID VOLLMER, SENIOR DIRECTOR, QUALITY CONTROL, 4LIFE RESEARCH

“ OpenLAB ECM is very automated. Every time a run is complete, it will pop up a window. All we have to do is hit enter and it will store the data to ECM.”

ASHLEY WILSON, CHEMIST II, 4LIFE RESEARCH

“ We can link all the raw data from an ICP-MS analysis that resides in OpenLAB ECM to an OpenLAB ELN report. They work hand-in-hand.”

ASHLEY WILSON, CHEMIST II, 4LIFE RESEARCH

Benefits

• Provides content management capabilities needed for 21 CFR Part 11 compliance: secure, centralized storage, audit trail, e-signature and version control

• Ensures audit readiness: data and results are organized and easy to retrieve

• Supports product quality monitoring using historical results

• Captures data and results obtained from many software and instruments, regardless of vendor

• Saves time, and reduces paper use and tedious, error-prone transcription

Enhances product quality tracking

4Life monitors the quality of their raw material and finished products. The R&D group develops raw material acceptance criteria, and the quality control lab verifies raw material identities against these acceptance criteria to ensure finished products match the product label, and are of consistent quality and safety.

Because OpenLAB ELN stores all results, 4Life can readily use historical data to evaluate trends in the raw materials, impact on product quality. These trends are used to develop and refine raw material acceptance criteria for future batches.

4Life Research staff

Agilent Products are for Research Use Only.Not for use in diagnostic procedures.

Information, descriptions and specifications in thispublication are subject to change without notice.

© Agilent Technologies, Inc. 2014Published in USA, January 27, 2014

5991-3902EN

Saves time, reduces paper use and transcription errors

OpenLAB ECM and OpenLAB ELN provide many easy, timesaving ways to gather and store the raw data and results obtained from the analytical systems used, significantly reducing paper use and chance of transcription errors.

Though the FTIR system used to perform identity analyses is not from Agilent, the print to PDF capability is used to capture spectra electronically for storage in OpenLAB ECM. Prior to deploying the OpenLAB solution, FTIR spectra were printed and attached to a manually prepared paper certificate of analysis (CoA). Today, the analyst sends the PDF file of the spectrum directly from the FTIR software to OpenLAB ELN, where it is stored with the electronic CoA.

To further curtail paper use and transcription errors, 4Life uses tablet computers running OpenLAB ELN to enter data obtained from devices such as balances, and pH and viscosity meters, into OpenLAB ELN. Prior to using the tablets, this data was recorded in paper notebooks and then transcribed into electronic form.

“ Another nice thing about OpenLAB ELN and ECM is though our FTIR is not an Agilent product, putting that data in is pretty seamless. We can send spectra to the cyber printer and pull it straight into OpenLAB ELN. It’s a lot faster and more efficient, and you don’t make mistakes for example transposing a number. Overall, it saves about 15 or 20 minutes per identity analysis.”

KATHY JESSOP, CHEMIST I, 4LIFE RESEARCH

“ Learning and using OpenLAB software has been really simple. An Agilent rep provided on-site training for each of the systems. We learned about OpenLAB ECM in a day and that was sufficient.“

ASHLEY WILSON, ANALYST, 4LIFE RESEARCH

To learn more about the OpenLAB Software Suite, visit: www.agilent.com/chem/openlab

To learn more about OpenLAB ECM, visit: www.agilent.com/chem/openlabecm

To learn more about OpenLAB ELN, visit: www.agilent.com/chem/openlabeln