Leading Engineering Content Management Solution Enables Global Healthcare Company to Improve Efficiency of Capital Projects, Streamline Turnover of Critical Information between Operations and Maintenance, and Ensure FDA 21 CFR Part 11 Compliance
Online PR News – 12-March-2013 – Exton, PA – March 11, 2013 – – BlueCielo ECM Solutions, a leading global software company offering engineering content management (ECM) solutions, announced today that Grifols Therapeutics Inc. (Grifols), a wholly owned subsidiary of Grifols SA, has used the BlueCielo Meridian Enterprise solution to achieve operational benefits, including good manufacturing practice (GMP) compliance, capital and maintenance project efficiency, and cost reductions.
Grifols has deployed BlueCielo Meridian Enterprise to control access to plant-wide technical documentation and drawings while simultaneously allowing their parallel use within maintenance and capital projects. The validation of the GMP solution and the assurance of adherence to 21 CFR Part 11 requirements were expedited through the use of a suite of validation documentation templates from BlueCielo.
Several add-on modules have been implemented to extend access to the vital information, including the BlueCielo Meridian Advanced Project Workflow Module. This module provides complex project management and concurrent engineering in order to facilitate simultaneous controlled use of documentation between the capital projects team and the rest of the organization. A second add-on, the Asset Management Module, enables integration with the computerized maintenance management systems (CMMS) for seamless access to asset information directly from the BlueCielo Meridian Enterprise vault. This module allows IBM Maximo users to quickly obtain asset-related documentation using asset tag values. For collaboration with external parties, the BlueCielo Meridian Enterprise–Microsoft SharePoint integration has been implemented, which allows secure, seamless exchange of project information outside of the company’s firewall.
“Grifols has realized the anticipated efficiency gains in our capital projects and in streamlining information turnover between operations and maintenance,” said Larry Lane, Director of Project Engineering at Grifols. “Additionally, BlueCielo’s life sciences experience and quality-based implementation processes contributed to the successful system validation.”
"We continue to see a rapid adoption of the BlueCielo Meridian Enterprise product suite in the biotechnology and pharmaceutical industry,” said Brian Sallade, BlueCielo’s North American COO. “A growing number of global life sciences companies are optimizing their processes of managing critical engineering content. With efficient validation processes and the availability of accurate engineering information to the relevant people throughout the enterprise, companies are now better able to manage and share all required GMP documentation and to more easily comply with the FDA's 21 CFR Part 11 regulation.”
Grifols is a global healthcare company with a 70-year legacy of improving people's health and well-being through the development of life-saving plasma medicines, hospital pharmacy products, and diagnostic technology for clinical use. As the third largest global producer of plasma medicines, Grifols has a presence in more than 90 countries and is the world leader in plasma collection, with 150 plasma donation centers across the U.S. Grifols is committed to increasing patient access to its life-saving plasma medicines through significant manufacturing expansions and the development of new therapeutic applications of plasma proteins. The company's class A shares are listed on the Spanish Stock Exchange, where they form part of the Ibex-35 (MCE:GRF). Its non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ via ADRs (NASDAQ: GRFS). In 2011, Grifols' sales exceeded 2,300 million Euros. The company is headquartered in Barcelona, Spain, and employs more than 11,000 people worldwide. For more information visit www.grifols.com.
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