In Life Sciences
SANTA CLARA, CA, Aug 22, 2017 – Propel, a modern cloud product lifecycle management (PLM) software company, today announced general availability of its Medical Validation Pack (MVP) for the life sciences industry. The Propel MVP offers pre-configured, out-of-the-box best practices to help life sciences companies build in product and process quality using Propel’s cloud PLM system. While many PLM solutions solely focus on engineering and quality, Propel also enables life sciences companies to work with everyone needed for digital transformation. Propel helps medical companies more easily and securely collaborate with strategic customers, technology partners, suppliers and channel partners on product development, sales enablement, regulatory compliance and customer adoption.
The Propel MVP is a complete set of validation document templates that enable customers to significantly reduce validation time and costs when deploying Propel’s cloud PLM software. Propel customers can more easily adhere to regulatory standards like ISO 13485, FDA Total Product Life Cycle (TPLC), 21 CFR Part 11 and 21 CFR Part 820. In addition to providing a pre-validated solution, Propel works with customers on planning, managing, testing, and preparing for validation. After initial validation, Propel performs regression testing on every subsequent software release, including documentation of all upcoming features, feature risk, and enablement details.
“Propel’s Part 11 compliant PLM solution can help life sciences companies like R2 Dermatology collaborate better and bring high-quality medical devices to market faster,” according to Bijesh Chandran, senior director of Regulatory Affairs and Quality Assurance at R2. “R2’s vision is to become the most admired company in dermatology in the minds of our customers and their patients, our commercial partners, our clinical advisors, our stakeholders, and our employees. Propel’s validated PLM solution plays a key role towards R2 realizing that vision.”
Propel Features and Highlights
- Pre-configured design history files (DHFs)
- Support for device master records (DMRs), including all structures and specifications
- Integrated customer complaint, issue and CAPA management
- Training record management
- Secure collaboration for design partners, suppliers, channels, and customers
- Validation master plan (VMP)
- IQ, OQ and PQ protocols, scripts and results
- User (URS) and functional requirements specifications (FRS)
- Approval and trace matrices
- Data migration protocols
- Validation summary report (VSR)
“Life sciences companies always need to meet strict quality standards, and Propel’s new MVP will make it easier than ever for companies to get validated, live and compliant,” said Brian Sohmers, chief product officer of Propel. “Of course, we’re helping companies improve product quality and compliance. What’s even more exciting is that life sciences companies finally have a robust cloud PLM system for digital transformation, and they can finally collaborate with everyone they need to make their products a success in the market.”
Propel provides cloud product lifecycle management software that helps you bring your customers closer to your products. With Propel, your customers can participate in every part of the product lifecycle, from capturing customer needs to roll out updates across all channels. Based in the heart of Silicon Valley, Propel offers modern and collaborative PLM capabilities built on the Salesforce App Cloud.
For more information, visit propelPLM.com.