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.
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 resulting in $60,000-$80,000 in cost-savings in the first year of deployment.
"We selected Omnify Empower because we found that there are very few cloud/hosted PLM systems out there that are cost-effective while ensuring that there are no compromises on features and controls required for meeting regulatory requirements," stated Manoj Raghuraman, Program Director, Algisyl for LoneStar Heart, Inc.
|•||Cost-effective, cloud-based, scalable solution|
|•||$60,000 - $80,000 in savings in the first year of deployment|
|•||Faster communication with suppliers and partners|
|•||Reduced Engineering Change Order cycle time|
|•||Adhere to 21 CFR Part 11 compliance for electronic records|
|•||Easier to meet compliance with centralized information|