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Ensure compliance to regulations such as FDA and EU and various industry standards with secure access and electronic signatures, audit trails of each action, and risk management incorporated in all processes.
Selling products into global markets requires that product designs, complaint processes, and commercialization efforts remain in compliance with all domestic and foreign government and agency regulations.
But it’s not easy. Even though many requirements are similar, such as audit trails, quality control, and complaint tracking, specific documentation and reporting vary by country, industry and regulation. Automating processes is needed to maintain compliance without overburdening limited human resources.
But done well, regulatory compliance ensures safety and success for manufacturers in both domestic and foreign markets.
Achieve compliance faster and with less effort using pre-defined templates, workflows and approved processes.
Gain efficiency and reduce risks using automated processes and reports to reduce errors, identify issues faster, and maintain regulatory compliance.
Achieve and maintain compliance across domestic and global markets to secure new revenue sources.
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Comply with regulations such as FDA and EU along with industry standards like ISO 13485, 21 CFR Part 11, and 21 CFR Part 820 using pre-defined templates, workflows and reports.
Resolve customer complaints and QA investigations to improve product safety and customer loyalty. Fully integrate to case management systems to leverage customer insights.
Manage CAPA, SCAR, NCMR activities with flexibility to configure forms and workflows as needed for regulatory and customer requirements.
Propel’s Digital FDA Submission capabilities help regulatory and quality teams easily and efficiently manage the entire process with the FDA.
Incorporate PLM, QMS and supplier management capabilities on a single platform to enable collaboration and improve quality before a product ships.
Streamline regulatory compliance by managing employee certification on the latest product changes and processes throughout the product lifecycle.
By moving to Propel, ASP consolidated 6 enterprise QMS applications into one fully integrated PLM and QMS solution to more efficiently managing FDA submissions within one single platform.
Speed your products to local and global markets while easing the burden of regulatory compliance
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