Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Jill Roberts
Another way to know what’s too old to eat
Patricia Santos-Serrao
Four pharma quality trends
Del Williams
Preventing damage caused by large, suspended particles
Kari Miller
An effective strategy requires recruiting qualified personnel familiar with the process and technology

More Features

FDA Compliance News
Now is not the time to skip critical factory audits and supply chain assessments
Google Docs collaboration, more efficient management of quality deviations
Delivers time, cost, and efficiency savings while streamlining compliance activity
First trial module of learning tool focuses on ISO 9001 and is available now
Free education source for global medical device community
Good quality is adding an average of 11 percent to organizations’ revenue growth
Further enhances change management capabilities
Creates adaptive system for managing product development and post-market quality for devices with software elements
VQIP allows for expedited review and importation for approved applicants that demonstrate safe supply chains

More News

Locus Technologies

Locus Technologies’s default image

FDA Compliance

Locus Introduces Worldwide Accreditation of Analytical Laboratories E-Data Delivery

Once accredited, the labs are added to the list of accredited labs on the Locus website.

Published: Monday, June 28, 2010 - 14:27

(Locus Technologies: San Francisco) -- Locus Technologies (Locus), a provider of web-based environmental compliance and information management software, has introduced an accreditation process for analytical laboratories to deliver analytical data into Locus’ award-winning, cloud-based environmental information management (EIM) system. A growing need exists for a standardized format for transmitting environmental electronic data. There are more than 15 different standards in use in the United States alone, most of which are antiquated.

Standards in the rest of the world also lack consistency leading to increased processing costs by all consumers of analytical data. The Locus electronic data deliverable (EDD) accreditation process is intended to help industry and analytical laboratories drive standards, consolidation, and ultimately, the creation of error-free defendable datasets.

The formal process includes the generation and upload of test EDDs to ensure that each laboratory information management system, or LIMS, can deliver data according to Locus EIM and customer requirements. This testing is followed up by a training session that covers how to upload EDDs into EIM, and to resolve common errors that may be automatically flagged as the EDDs are evaluated for errors. The objective of the accreditation process is to have laboratories gain the necessary experience and expertise to routinely deliver error-free submittals of analytical results to EIM, thus allowing the data to become actionable and consumed by consultants and site owners almost immediately.

There is a nominal accreditation processing fee and annual renewal that is easily recovered through gained efficiency. Laboratories that would like to become accredited and meet certain criteria can apply at Locus’ website. The accreditation process may take up to 90 days. Once accredited, the labs are added to the list of accredited labs on the Locus website. During the initial round, Locus accredited the following laboratories:

United States: TestAmerica, Tennessee and California; Accutest, New Jersey and Massachusetts; Calscience, California; Lancaster Labs, Pennsylvania; Columbia Analytical, Air Toxics, BC Laboratories, Del Mar Analytical, Merit Labs, Xenco Labs, and Oilfield Environmental and Compliance Inc.

Worldwide: Maxxam, Canada; BMG Engineering, Switzerland; ALS Environmental, Australia; Wessling Laboratory, France; Eurofins (Analytis), Germany; CHELAB s.r.l. and LAV s.r.l., Italy; Analytico Milieu n.v., Netherlands; Pace Labs, Puerto Rico; and Pro Analysis, Argentina.

In 2007, Locus introduced a set of standard EDD formats for the reporting of environmental laboratory analytical data. Since that time, Locus has witnessed exponential growth in the number of EDDs submitted from the laboratories directly into the company’s flagship product, EIM. Locus customers, analytical laboratories, and consulting companies have benefited from the standardized format and automated work-flow process for transmitting EDDs directly into EIM via the internet, bypassing the manual e-mail-based approach, thus significantly reducing processing and rework costs.

The contents and flexibility of the Locus EDD formats permit data to be validated on arrival into EIM to EPA Level II, if a customer so desires. Locus envisions its formats to be transitional for the companies and laboratories that are not yet ready to adopt XML-based technology but are tired of dealing with multiple and antiquated file formats, which only serve to increase costs. In addition, some of the old format “standards” suffer from the requirement that data be submitted in multiple files, while other formats have antiquated requirements related to field lengths or valid values that originated at a time when hard disk space was at a premium. Locus’ EDDs eliminate these requirements.

“Locus believes that the promulgation of a standardized single-file format will allow laboratories to reduce the costs of creating EDDs, minimize errors in the transmission and reporting of data, and more quickly support new EIM clients while reducing processing costs,” says Locus president and CEO, Neno Duplan.

“Our clients are acutely focused on data management and deliverables’ challenges and it is key to our mission to provide solutions in this regard,” says TestAmerica president and CEO Rachel Brydon Jannetta. “Whenever we can work with a firm such as Locus to enhance the link from the lab data to environmental decision making, we know we have added value to our client’s objectives.”

“As the leader in environmental data management software, Locus strives to provide guidance, direction, and endorsement to the best ideas in an effort to standardize data management processes,” adds Duplan. “Such efforts are sorely needed in an industry that is experiencing explosive growth in the volume of analytical testing. Currently, there are more than 15 different standards for analytical data submittals and this needs to change. We believe that the standards that Locus has introduced and that much of the industry now follows, coupled with our accreditation program, will help drive greater uniformity, lower overall costs, and lead to better and faster reporting of environmental data.”

Locus’ flexible EDD processing tool will continue to support all major regulatory-driven standards from the U.S. Environmental Protection Agency (EPA), and the U.S. Army Corps of Engineers (USACE)-based staged electronic data deliverable (SEDD) format, and California’s Water Resources Control Board AB2886 reporting requirements on electronic data format (EDF).

Discuss

About The Author

Locus Technologies’s default image

Locus Technologies

Locus provides business with the power to be green on demand. Locus pioneered cloud computing environmental software suites. Locus’ software enables companies to organize and validate all key environmental information in a single system, which includes analytical data for water, air and soil, greenhouse gases, sustainability, compliance and environmental content. Locus software is delivered as an on-demand service (SaaS), so there is no hardware to procure, no large up-front license fee, and no complex set-ups.