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Industry Summary Articles

Tuesday, March 17, 2015

LoneStar Heart Reaps Benefits of Cloud-Based PLM from Omnify Software

Omnify Software today announces that LoneStart Heart, Inc., a developer of cardiac restorative therapies for patients with heart failure that harness the heart's ability to repair itself, has reported cost-savings of up to $80,000 within the first year of deploying Empower PLM.

LoneStar Heart was looking to gain efficiencies in product design and development by replacing their paper-based document control processes with an electronic system. As a developmental stage start-up, they wanted a cost-effective, cloud-based solution that would scale as the company grew. To meet Food and Drug Administration (FDA) requirements, the solution also had to adhere to FDA 21 CFR Part 11 guidelines for electronic records and electronic signatures and with plans to allow external partners such as consultants, development partners and suppliers access to necessary documentation, they wanted customizable role-based user access controls. 

"Our existing IT infrastructure was cloud-based so naturally when we were looking for a PLM system we wanted it to be cloud-based as well," stated Manoj Raghuraman, Program Director, Algisyl for LoneStar Heart, Inc. "We selected Omnify Empower because we found that there are very few cloud/hosted systems out there that are cost-effective while ensuring that there are no compromises on features and controls required for meeting regulatory requirements."

LoneStar Heart is using the Empower PLM system to manage product Bill of Materials (BOMs), Engineering Change Orders (ECOs) and Documents as well as Training records. Centralized information and automated processes helped to reduce ECO cycle time, enable faster communications with suppliers and development partners, and make compliance with regulatory requirements much easier. "With these improvements we have realized an estimated $60,000 - $80,000 in savings in the first year of deployment and this continues annually," stated Mr. Raghuraman.

"Although many of our customers are still on-premises, we have seen a surge in start-ups and smaller organizations like LoneStar Heart opting for a cloud deployment across all of their IT systems," stated Chuck Cimalore, Chief Technology Officer for Omnify Software. "We have always delivered products to help small to mid-sized companies take advantage of PLM technology, and the cloud is another way to enhance our offerings for this market." Recognizing that companies will have different deployment strategies, and that these strategies may, in time change, the Empower PLM system is designed to support cloud-based and on-premises platforms.

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