Moving away from paper-based document control

LoneStar Heart Inc., based in Laguna Hills, California, is developing cardiac restorative therapies for patients with heart failure that harness the heart’s ability to repair itself. Based on its integrated cardiomechanical and biomolecular technologies, the privately held company is advancing a broad portfolio of products to restore the failing heart’s structure and function in collaboration with the Texas Heart Institute, the University of Texas Southwestern Medical Center, and a global network of clinicians. These products include Algisyl, cardiac stem-cell modulators, and cellular and genetic therapies delivered as stand-alone treatments or in combination with the company’s biopolymer matrix system. Algisyl*, the company’s lead product, aims to treat advanced heart failure in patients with dilated cardiomyopathy.

LoneStar Heart was a developmental stage start-up when its principals began looking for a product lifecycle management (PLM) system. They were using a paper-based document control method that was functional, yet very resource intensive. They found themselves spending significant time searching and managing documentation that slowed actual design and development work. They wanted a solution that would automate the process and make it more efficient. With some employees based outside of company headquarters, having a solution that offered the ability to securely allow all employees access to the necessary documentation/information was also essential.

The LoneStar Heart team compiled a list of requirements that they used to compare different solutions. Their goal was to find a cost-effective, cloud-based system that would scale as the company grew. LoneStar Heart’s existing IT infrastructure was cloud-based, and it had employees who frequently traveled, and they wanted a cloud-based PLM/document control system that did not require local servers.

Being a medical device manufacturer, the solution LoneStar Heart selected had to adhere to FDA 21 CFR Part 11 guidelines for electronic records and electronic signatures. In addition, with plans to allow external partners – such as consultants, development partners, and suppliers – access to necessary documentation, the company wanted customizable role-based user access controls. As a final point, the system had to be intuitive with an easy learning curve.
 

Solution/success

After comparing several systems,officials selected Empower PLM from Omnify Software.

“Based on our comparisons, we found that there are very few cloud-based PLM/document control systems out there that are cost-effective while ensuring that there are no compromises on features and controls required for meeting regulatory requirements,” states Manoj Raghuraman, program director, Algisyl for LoneStar Heart Inc. “Omnify’s cloud-based system met all of our requirements and helped us avoid having to install and maintain local servers. This alone is equal to about $25,000 to $40,000 in savings annually for us.” LoneStar Heart is using the Empower PLM system to manage product bill of materials (BOMs), engineering change orders (ECOs), documents, and training records. Empower helped LoneStar Heart address issues associated with a manual document control environment. Centralized information and automated processes provide easy yet secure access to information for all employees, help reduce ECO cycle time, enable faster communications with suppliers and development partners, and make regulatory requirement compliance much easier.

“With these improvements we have realized an estimated $60,000 to $80,000 in savings in the first year of deployment, and this continues annually,” Raghuraman says. “Omnify takes a hands-on approach in ensuring successful deployment of its software, and effective collaboration with our dedicated applications engineer early on has been instrumental in our successful deployment and immediate results.”

Omnify Software
www.omnifysoft.com