Quality shouldn't start after a product is sold.

But that’s exactly how many QMS tools operate, with little connection to the product record and a focus on problems that should have been avoided in the first place. You and your customers deserve better. 

With Propel, quality is woven throughout. Tracking inbound component quality. Monitoring supplier performance. Informing engineering with quality insights to embed in designs. Ensuring compliance. And helping all teams speed the resolution of customer issues.

Benefits

25%

Faster Customer Issue Resolution

30%

Less effort to achieve compliance

30%

Faster product launches

Propel QMS Reduces Expense, Mitigates Risk, & Drives Top-line Growth

Manage Inbound Quality

Track and trend component part quality and supplier performance to inform engineering designs and take corrective action.

Deliver High-Quality Products

Use real-time insights to enable an enterprise-wide approach to quality. Build brand loyalty by meeting or exceeding buyers’ quality expectations.

Get & Stay Compliant

Achieve and maintain compliance across global markets to secure new revenue sources. Manage DHF, DMR, SOPs & training records. Investigate complaints and streamline adverse event reporting.

Optimize Customer Experiences

Investigate and quickly resolve customer issues. Enact preventive measures to eliminate recurrence

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Key Propel QMS Capabilities

Compliance management

Comply with regulations such as FDA and EU along with industry standards like ISO 13485, 21 CFR Part 11, and 21 CFR Part 820. Manage compliance with secure electronic signatures, password security, audit trails of each action, and risk management incorporated in all processes, along with a validation pack with executed IQ and OQ and template PQ scripts for all processes.

CAPA

Incorporate Corrective And Preventive Action plans, implementation plans, risk analysis, and effectiveness checks. Get greater flexibility to configure the forms and workflows necessary to meet your customer's specific needs and expectations.

SCAR

Easily notify and involve suppliers when a Supplier Corrective Action Request is in process, conducting supplier investigations and root-cause analysis in one information hub.

NCMR

Integrate your Non-Conforming Material Report with other QMS processes such as CAPA and audits. Describe non-conforming material via configurable forms and workflows. Record non-conforming material and related supplier information to comply with FDA and ISO regulations, following  industry best practices.

Customer complaints

Resolve customer complaints and QA investigations to improve product safety and maximize customer loyalty. Fully integrate with Salesforce Service Cloud and other case management or customer service systems to leverage customer insights. Meet specific customer needs with fully configurable fields and workflows. Lower the risk of errors and non-compliance by incorporating decision trees that determine regulatory reporting requirements.

Supplier management

Manage the onboarding and qualification of new suppliers. Support audits and electronic approvals. Strengthen supplier collaboration to quickly resolve product and supply chain issues, minimize the risk of noncompliance, and improve product quality. Understand preferred and alternate sources, field replaceable units (FRU), cost parameters, and part availability.

Deviation management

Quickly identify deviations from normal processes to ensure your organization is compliant with FDA and ISO regulations and practices.

Training records management

Confidently pass audits and improve product and employee safety with a comprehensive training record management solution that includes full employee training transcripts, document-based training and quizzes, automated retraining, and training analytics. Streamline regulatory compliance by managing employee certification on the latest product changes and processes throughout the product lifecycle.

Risk management

Incorporate risk management into all of your processes to minimize adverse reactions. Incorporate engineering change orders, CAPAs, and NCMRs into all of your processes. Precisely calculate the risk score for events based on parameters, such as issue severity and occurrence frequency, through a reportable risk management matrix.

Audit management

Take preventive actions and make informed business decisions based on data-driven audit insights. Manage internal, external, and supplier audits and share information about upcoming audits and audit results with respective stakeholders.

Equipment calibration & maintenance

Create Equipment and subsequent Maintenance records.
Determine and calculates if and when Equipment requires routine Calibration and/or Preventive Maintenance.  
Manage Equipment Manufacturers, Site Location, Model and Serial Numbers, as well as Equipment Qualification and Software Validation.

Product registration

Manage & track global product registrations and licensing for the countries in which you sell. Accurately plan, design & forecast product and sales into new markets. Streamline registration creation, maintenance, expiration and renewal. Ensure compliance, understand global impacts, and minimize inventory disruption.

eIFU (Instructions for Use)

Collaboratively manage the IFU throughout the entire product lifecycle. Publish accurate and localized versions of IFUs in the regions where the device is sold.
Eliminate errors typically associated with manual information entry and system integration.

Adverse event reporting

Fully automate reporting through decision trees, regulated agencies tracking, support for electronic MedWatch FDA 3500A Form, and one-click submission. Keep track of the outbound electronic eSubmission package and all acknowledgements as proof for audits of reporting compliance.

Trusted by Industry Leaders

Learn how ASP is bringing Innovation to its Quality and Regulatory processes

  • Completely redesigned 7 major processes to increase automation and traceability
  • Removed 30-45 days from the case to complaint process
  • Automated stop shipments across multiple DCs serving 130 countries
  • Connected global product registrations to their order entry systems
The Only Product and Quality Platform
Built on Salesforce

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