With Propel, quality is a core aspect of the product definition, woven throughout all roles and processes: planning & design, sourcing & production, sales & service.
Propel drives continuous quality improvements by addressing part, product, process, and supplier quality. The results: Better, safer products. Happier customers. And higher profits.
Track and trend component part quality and supplier performance to inform engineering designs and take corrective action.
Use real-time insights to enable an enterprise-wide approach to quality. Build brand loyalty by meeting or exceeding buyers’ quality expectations.
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.
Investigate and quickly resolve customer issues. Enact preventive measures to eliminate recurrence
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With best in class document traceability and easy to manage workflows, Propel Document Management enables nimble corporations to build things fast and maintain cGMP practices and compliance with ISO 9001:2015 / 13485:2016 requirements.
Propel's intuitive document tree structure lets you see all of the document relationships and dependencies from any record. Review where the document is used and referenced with just a single click. Users are always aware of any open Quality events that relate to the document.
Leverage industry best practice workflows and easily configure (CLICKS, NO CODE) your specific business requirements including approval or review processes, category specific attributes and phase notifications for your controlled documents. Propel Document Management lets you categorize your documents to drive unique behavior for workflows, lifecycle phases, autonumbering, notifications and more.
Stay audit ready always with e-signatures, approval history and audit trails for a fully compliant and easily validated system of record.
Propel gives a complete view of attachment versioning, e-signatures, approval/rejection comments, no need to keep following up for wet signatures from stakeholders or managing hard copies.
Propel provides complete visibility on what changed via redlines, and gives access to the complete history of revisions and changes associated with the document. Compare versions to see what changed over time, and be able to limit access to superseded revisions and pending drafts.
Collaborate better with Propel's built in integrations for Google Drive and Office 365 cloud authoring tools, enabling content authors to work together on secure online documents, providing higher efficiency and reduced cycle time.
Skip the overhead and let collaborators focus on content with pre-approved attachment templates for each document category. Sync key record data into files when you're ready to for review.
Propel's automatic watermarking and PDF reports let you stay on top of compliance without making it the top of a to-do list. From documents to spreadsheets, presentations to PDFs, Propel has regulated document management covered, automatically.
Reduce iterations and change order cycle times by efficiently managing your change orders. Configure the right approval workflows and manage product updates across the entire value chain.
Propel’s cloud-based platform promises you the required agility, flexibility, and configurability to easily review and approve any changes in your quality eco system. With interactive dashboards you will always have the right information at your fingertips.
Managing document and product hierarchies is a time consuming and exhaustive experience. Any impact to child items may impact the parent, and vice versa.
Propel gives complete insight into the organization's document hierarchy and provides a seamless and intuitive approach to managing changes to document hierarchies.
It is imperative to know of any existing downstream/upstream impact of change. This forms the basis of an effective change management structure within an organization.
With Propel, stakeholders get real-time visibility on any existing open quality issues related to the items "in change" or change requests. This makes decisions to approve or reject changes faster and more complete.
Built in risk assessment for changes comply with the medical device regulations. Associating risks to change also helps in defining risk-based approvals for changes.
By design, Propel has a risk assessment step associated with each change. It also leverages the "Criteria-based Approval" design to dynamically assign approvers for a change based on the associated risk.
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.
Seamlessly integrate item- or document- based trainings and competency assessments using Propel's training records. Organize your training around roles, departments, and locations so your employees get the proper training they need to be successful. In addition, support for classroom and instructor-led training, bulk sign-offs and dual-signatures.
Never miss a beat -- when product or process updates are approved, Propel automatically generates the necessary training assignments to keep your workforce up-to-date and compliant. Or, set up periodic reviews to establish a regular cadence of retraining so you can ensure compliance and competency.
Manage retrainings on policies and procedures without the need to revise those documents. Per cGMP requirements, ensure employees are retrained on essential policies and procedures on a recurring basis.
Propel sets up training plans to facilitate retraining without revising the associated document. This is exceptionally valuable functionality to keep employees refreshed with critical company policies and procedures. In addition, training administrators can enable periodic rolling retraining based on the date of each trainee’s last assignment which greatly reduces administrative maintenance.
With intuitive dashboards and interactive UI, employees are always up to date on upcoming or past due training assignments.
Propel leverages powerful Salesforce reporting capabilities to generate informative, interactive and real-time dashboards so management stays audit ready all the time.
Prevent non conformances by establishing best practices of downloading the related material and uploading supporting documentation of their competency.
Measure competency and flag potential risks by adding in Propel's flexible training quizzes to key competency assessments.
Assess, control, and monitor risk across your products, processes, projects, and suppliers. Identify risk trends and resolve them proactively across product lines with data-driven design changes.
Propel streamlines risk management across the entire product lifecycle, including workflow-driven processes that capture and reduce risk, leading to more efficient audits and inspections.
Seamless case to complaint process leads to more accurate investigation, root cause and corrections. Gain immediate understanding of the impact across quality and product by knowing where used, where sourced and where sold, which can automatically trigger ship holds for distribution and selling actions. Propel ensures cross-functional teams and suppliers work synchronously to attain the right corrections, actions and fixes, reducing overall resolution time.
An integrated case, complaint, non conformance, CAPA and change process leads to lower product risk and higher customer delight. Teams can collaborate on the risk files, assessment, and controls in a secure, single source of truth. Having Propel on one common platform ensures quality corrections and engineering fixes can be easily propagated to service and sales, and realized by the customer.
Provides cross-functional visibility to both quality and product and reduces the risk of recurring and repeating issues. Enables engineering to see historical quality events so they don't design existing issues into the next generation, or new products. Enables design for quality and regulatory to occur earlier in the NPD process, reducing downstream and future issues, lowering risks and creating better outcomes.
Reduce development timelines with greater flexibility, visibility, and productivity with our modern approach to bill of materials. Compare revisions, visualize redlines and retain multiple work streams without breaking out of a workflow. In addition, Clipboard enables easy copy of BOM items, Item revisions, recently viewed and Affected Items, and paste them into other tables for lightning fast work. BOM Navigator displays the BOM in a hierarchical structure that easily drills down various levels while viewing details, without having to navigate to another window.
BOM must include all levels including the subassemblies and components with correct quantities, cost and suppliers. BOM must also include all the details relevant to the definition of the product. Propel enables organizations to capture all of this, and more, in the BOM structure including:
-Raw material and associated quantity
-Assembly & subassembly hierarchy
-Associated manufactured part cost with manufacturers parts numbers (MPN)
-Customer facing model numbers or Stock Keeping Units (SKUs)
-Multiple BOM viewing options (flattened, structured, with manufacturer, cost)
-Automatic detection of BOM errors
-Procedures, tooling and warranty
Find all item information under one record, including: description, revision, bill of materials (BOM), manufacturer part number (MPN), manufacturing cost, Where-Used and related items.
Propel's Item master is the single source of truth in making informed decisions in pre-market through post-market product lifecycle.
Propel can be easily integrated with external ERP systems to push, or pull, item data in real time. All integrations are supported with the latest Salesforce integration stack, and are using best-in-class authentication protocols for data security.
Immediately know where a part is used across all products. Propel's Where-Used capability will show everywhere each part and document is used, from immediate parents, all the way up to top-level parents. Determine where every part revision is used across BOM, AML, environmental specifications and when tied to software versions.
Obtain real-time rich part history with visibility into when parts are single sourced, obsoleted, alternated, or selected as preferred. Understand ongoing quality history with dynamic link to quality events, ensuring design issues are not propagated into next-generation and new designs.
Cultivate customer delight with complaint management that’s integrated and easy-to-use from intake to investigation, resolutions to regulatory requirements. Maximize customer loyalty and improve product safety by resolving customer complaints faster.
Propel is fully integrated with Salesforce Service Cloud and other case management systems so your sales and service teams can stay proactive and ensure customer satisfaction. Ensure efficient complaint management with our best-in-class workflow template that's fully configurable to meet your specific customers' needs. Lower the risk of errors and non-compliance by incorporating decision trees that automatically determine global regulatory reporting requirements.
A truly comprehensive complaints management system provides the ability to submit reportable events to regulatory bodies in a fully automated, controlled and timely manner.
Propel provides an electronic Medwatch 3500A form for Electronic Medical Device Reporting (eMDR) to ensure timeliness and acknowledgement on issue reporting to FDA ESG including managing any necessary follow ups. Stay notified and informed of upcoming due dates, and issue trends with interactive reporting and dashboards, right from your home page.
Seamlessly keep CRM in sync with the latest investigation updates with Propel's case-to-complaint plugin for Salesforce Service Cloud users. Easily connect existing processes to Propel's Complaint Management module with several integration options and open APIs available for any upstream sales and service system.
Ensure efficient complaints management on day one with best-in-class workflow templates. Connect related cases, complaints, NCMR, CAPA and any other quality events, suppliers, parts and documents to bring surveillance full circle. Propel provides the ability to easily configure ("CLICKS, NO CODE") and extend to other business processes and systems, with standard integrations, and an extensive partner network.
Success of your QMS system depends on its ability to manage Corrective and Preventive actions efficiently and effectively. This is what drives continuous improvement in the connected business ecosystem of modern product companies.
Propel's CAPA process is engineered to define, manage, and address root causes so you can prevent recurrences and future non conformances. CAPA is one of the backbones of Propel's QMS offering.
Remove the overhead associated with excessive documentation and unnecessary approval requirements with a best-in-class approach to CAPAs.
Propel's CAPA process has predefined rules to manage approvals. The ability to link individual tasks, associate deliverables to each task, and get final sign off on verification and effectiveness ensures quick and efficient resolution of non conformances.
Any impact to parent assemblies or sub assemblies due to a non conforming child item and vice versa, can be easily identified to correctly assess the impact of CAPA.
Propel gives complete insight into assembly hierarchies and provides seamless and instantly shows the immediate parents and top level parent for an item.
It is imperative to know of any existing quality issues with the non conforming Item to correctly assess the root cause. This forms the basis of an effective CAPA process within an organization.
With Propel, stakeholders get real time visibility into any existing open quality issues related to the affected items, providing crucial data for smarter decision making.
Ensure pristine performance with a compliant system that enables you to proactively prepare for all your audits and inspections.
Planning makes perfect - stay on top of and in control of your audit schedules, checklists, and reports, and keep stakeholders informed.
Trust a proven system that’s effective and flexible to handle your external, internal, and supplier audits.
Eliminate process inefficiencies by using Propel to manage your audit process automatically, from planning to reporting.
Launch Audits from pre-defined templates and keep on track with audit schedules thanks to Propel's easy audit scheduling and automatic alerts. Templates make key record organization and distribution to internal and external parties a breeze.
From generating multiple audit type templates to associating questionnaires for each audit type, Propel's "CLICKS, NO CODE" approach is easily configured.
Track findings from audits and escalate to CAPAs or SCARs for investigation with a single click. Launch product and process changes to correct root causes, and report on status in real time.
Propel's connected system ties quality issues, suppliers, parts, and documents together to own a true closed-loop system from day one, right out of the box.
Experience smooth and hassle-free audit management with the ability to collaborate with suppliers directly in Propel. The entire process of completing pre-assessment questionnaires, tracking responses, and following up findings is collaborative and easy for suppliers to adopt. Enable organizations to focus on building better quality, instead of chasing down loose ends and trying to wrap arms around the current status.
Integrate your Non-Conforming Material Report (NCMR) with your other Quality processes such as CAPA and Audits. Describe non-conforming material via our best-in-class templates and workflows. Record non-conforming material and related supplier information to comply with FDA and ISO regulations, following industry best practices.
Understand the impact on product lines and subassemblies in one click. Easily navigate and dig deeper into process and product elements impacted by a non conformance. Slice, dice, and serve up digestible pivot charts and tables. Easily identify data trends and examine records affected by such trends, all within interactive dashboards.
Get to the root of product and process non conformances, and take action right away. Launch CAPAs or SCARs associated with material dispositions and initiate changes needed to treat non conformities in a truly holistic manner, rather than adding band-aids on top of business problems.
Propel's simple design allows easy linking of CAPAs/SCARs to non conformances, supporting a fully traceable view of the related issues. Kick off the corrections, actions, and changes needed to stop the bleeding, and prevent it from recurring again.
Leverage open APIs to integrate Propel NCMR process with external ERP systems to manage inventory. Propel offers a complete suite of APIs, and a certified integration partner network to create a seamless quality suite interconnected with crucial business applications.
It is critical to ensure assets and equipment are properly calibrated and maintained to minimize non conformances due to incorrect readings. These non conformances can result in product recalls and serious safety issues to customers and employees alike. Propel's Equipment Maintenance and Calibration process enables organizations to properly manage equipment and mark it as active, or inactive, based on its calibration and maintenance results.
Propel drives regular equipment maintenance and calibration activities via timely reminders and notifications to predefined groups and maintenance personnel.
Propel's easy-to-use dashboards quickly identify which equipment is coming due, or past due, its maintenance and calibration cycle.
Keep investments accurate and active to ensure Return on Invested Capital (ROIC).
Automatically schedule, delegate, and execute calibration and maintenance to reduce repair costs and keep downtime minimized. Seamless integration to non conformances and CAPA modules keeps the workforce safe and compliant.
Design History Files (DHF) are the most essential aspect of design control to factually verify and prove that the team followed the design plan and successfully passed all requirements. DHF are a key clause under FDA 21 CFR 820.30.
Propel provides a scalable DHF model to be associated with each product. No need to store binders and folders on shared drives or file servers. Access to product DHF is easy and can be viewed on demand.
Teams can take snapshots of DHFs as the product moves through its lifecycle. This helps in prototype tracking and maintains a history of product build.
In Propel, DHFs can be revision controlled, thus every time a new product release is published, an associated DHF can also be published. This provides insight into the design control process followed by each product release.
Getting products to market can be a long journey. Over time there are many revisions, impact assessments, redesigns, and builds. As the product goes through the development lifecycle, so does the DHF. Additionally, updating a DHF does not end with product development and should be assessed for changes and revised when the product is out in the market. If not, the DHF will inaccurately represent the product in the market, potentially causing issues, such as during an FDA inspection.
Propel treats DHF as a controlled category. With each revision of the product, the associated DHF is revised based on the impact assessment done. This ensures that the DHF is always a "Living" document, remaining current and representing the latest approved version of the product (pre- or post-market).
Build DMRs (Device Master Record) following document control practices. Like any controlled document, any changes to DMR documents need to go through a revision process with a defined control process of reviewing and approving the change.
In Propel, DMRs can be created as a controlled document tracking revisions and change history. Propel leverages the out-of-the-box document control design to facilitate creation of DMR document categories and associated change control process to approve revisions.
Using paper based systems to manage DMRs has a lot of non value added effort. A large number of FDA inspections fail due to non compliance involving good documentation practices (GDP).
In Propel, DMRs can be linked directly with each product, and a full view of the product DMR can be accessed on demand. Additionally, Propel's document hierarchy structure can be used to create multi level relationships between DMR documents and associated products. No need to manage DMRs in a separate binder on a shared drive.
It is important to train employees on the manufacturing processes associated with a post-market product.
Propel can launch document-based trainings to ensure training compliance and safety of employees during the manufacturing of the associated product.
Regulated companies need to comply to agency requirements to ensure full control over electronic records and electronic signatures. This includes creating, modifying, archiving, retrieving and transmitting records while being both trustworthy and reliable.
Propel complies with 21 CFR Part 11 for electronic record and signatures. Propel provides all aspects of user security, automatic logoff, controlled access, and audit features and can be configured to meet your Standard Operating Procedure (SOPs). This helps our customers ensure they meet the regulatory framework.
Capturing clear and complete audit trails is a foundational component in a quality management solution. Full history of activities need to be automatically stored into an audit history where it is retained and easily available.
A complete audit history is captured and stored in Propel including timestamps and all actions such as create, view, modify and delete. A dedicated Audit History tab records every activity into an easy to read format.
Validation is often very time consuming, error prone, and burdensome. This demands a high effort to meet and continually stay compliant.
Propel provides a set of thorough documentation to help accelerate validation efforts. Installation Qualification (IQ) and Operational Qualification (OQ) is updated and included with every release, as well as pre-written Process Qualification (PQ) protocols for many key processes.
Retrieval of records must be easy for the right people at the right time. In addition, governing secure permissions and controls for any access and passwords for approvals.
Propel provides full access control of electronic records which includes access control by license type, profiles, permission and application control configuration. Different levels of control are easily configured to accommodate the various types of documents, approvals and changes for each customer.
Accurately plan, monitor and track global product registrations and licensing in the countries selling into. Address specific market requirements to incorporate them early - and often - into new product development processes.
Streamline registration creation, maintenance, expiration and renewal process. New registrations are easily created and tied to product(s). Efficiently collect all of the right data, files and approvals for each submission effort. Propel monitors upcoming expirations and renewals to ensure that deadlines are completed early and on time.
Achieve and maintain compliance, quickly assess global impacts and minimize inventory disruptions. In addition to ensuring successful registrations, it's important to control which product and it's revisions can be built and shipped. Propel's product record captures and communicates product revisions across the organization that can be built and shipped, avoiding excess costs, shipping, rework and scrap. Integrations to ERP & CRM ensure launch and market success.
Accurately plan, design and forecast product and sales into new and extended markets. Any issues, such as adverse events are quickly resolved cross functionally to continue selling.
Securely allow authorized representatives and distributors access to view select documentation and participate in project activities and approvals.
Easily visualize Dashboards showing registrations coming due, in-process, rejected, or expired. Run reports on which countries have active registrations by product revision.
Save time and simplify compliance to FDA 21 CFR Part 803 Medical Device Reporting using Propel’s Digital FDA Submissions.
Seamlessly propagate Customer Service Cases to Complaints for efficient investigation and reportability determination. Accurately and timely report adverse events that concern device-related death, serious injury or malfunction. Sync related Complaint data into the MedWatch 3500A Form and automatically trigger electronic eSubmissions to FDA ESG. Fully integrated with Propel’s PLM and quality capabilities, improving accuracy while streamlining the entire process.
Easily run one, to many, Decision Trees associated with the each relevant global agency. Traceability is captured across Decision Trees, Reportable Authorities and eSubmissions all tied together neatly.
Propel provides MedWatch 3500A Form electronically including any updates to sections and fields. Govern user privileges so each user is working on the correct form sections, filling out required fields and deciding when to trigger an automated eSubmission.
Eliminate errors, duplication, and late reporting. Propel automates electronic eSubmissions by sending to FDA ESG via AS2 machine-to-machine connections with full tracking of acknowledgements ACK1, ACK2, ACK3. Ability to do follow ups, form comparisons and tracks audit trail history.
IFU is available electronically in each of the relevant languages where being sold. User portal provides selection criteria such as Region, Country & Language options which result in only the valid list of IFU's revision(s) presented.
Avoid costly websites, file duplication and paper. Eliminate cost of outsourcing to 3rd party website and latency of changes. Save money in printing costs and environmental benefits including shipping return fixes.
Source of truth of the IFU is managed, changed and controlled in Propel throughout entire product lifecycle. One IFU can be leveraged across many products or product families. Propel allows cross-functional collaboration early and often in NPD, and easily propagate changes while in market.
Visualize and understand how each IFU connects back into quality systems. Easily navigate and dig deeper into the elements included or impacted by a IFU in a centralized view. Never miss a relationship between IFU, quality events, and products, which derive the information needed to make quality, data-driven decisions.
Propel helps ensure the right IFU revision is associated to the right product revision, decreasing liability and chance of product recall. Acceptance of eIFU will be much higher for users and notified bodies as accuracy and compliance is enforced. Propel is compliant to 21 CFR Part 11. Propel helps achieve eIFU compliance related to EU and FDA regulations such as MEDDEV 2.14/3, EU MDR Regulation (EU) 2017/745 and Commission Regulation (EU) No. 207/2012 on eIFU of medical devices.
Each company has its own requirements to qualify and re-qualify a supplier and assess its fit with respect to factors such as: product capabilities, quality record and reputation, delivery performance, Risk and compliance, environmental governance.
Propel's supplier management solution ensures that suppliers are periodically re-evaluated to ensure they meet compliance and company objectives. Poor-performing suppliers can be disqualified and removed from the AVL/ASL, and each of their approved manufacturer list (AML) components be moved from preferred to alternate, or removed.
Manage the process of evaluating and onboarding suppliers. Propel also qualifies and manages each of the supplier's parts that are approved for the product. Easily maintain approved vendor list/approved supplier list (AVL/ASL).
Suppliers need to be continuously monitored and confirmed to meet thresholds according to the service provided. Propel's dashboards and reports monitor metrics and trends such as supplier related complaints, SCARs, non conformances and performance.
Utilize online testing to streamline global training and reduce time to test as well as certify suppliers.
Manage supplier quality through well-defined and related quality workflows including CAPA, SCAR and audit processes. Ensuring suppliers are compliant and meeting acceptable quality standards reduces supplier issues, audit findings, and improves overall product quality.
Request a corrective action to a supplier (SCAR) for a non conformity related to the quality of its service/product provided to an organization. Suppliers can participate in a SCAR workflow, and actions, in a secure and controlled manner.
Reduce the risk on non conformity by managing robust workflows for SCARs. Involve cross-functional teams and suppliers as approvers and participants to ensure the completion and effectiveness of SCARs. Related quality events are connected to SCARs, ensuring both upstream and downstream workflows are closed and effective.
A secure environment for collaboration between original equipment manufacturers (OEMs) and authenticated suppliers to safeguard intellectual property (IP).
Propel defines role-based access levels at many levels such as product, BOM, component, AML, lifecycle, workflows, as well as select quality events.
Engage directly with suppliers on strategic designs and production specifications with contract manufacturers. Manage changes intuitively with redlining, draft BOMs, automated approvers, and mobile notifications.
Invite suppliers to select workflow and approvals such as SCARs and supplier audits. Empower suppliers to initiate improvements and requests through supplier change requests.
Propel provides embedded communication associated with the product definition to capture knowledge in context and improve decision-making throughout the development lifecycle.
Accelerate development cycles by automating workflows and assigning tasks to suppliers. Propel provides rich context and direct links to product artifacts, making it easy to delegate these to suppliers - and for them to complete their assignments.
Apply a consistent and data-driven method to rating suppliers based on Quality metrics and Compliance adherence. Utilize measures such as recalls and complaints, change and deviation management, materials management, process validation, and more.
Assess component risk with SiliconExpert grading based upon factors like availability, cost, environmental compliance, and delivery history. Assess risk of the supplier with real-time dashboards that aggregate all quality events, show component sourcing, and calculate graphs such as defects per million and scrap rates.
Track and manage supplier performance for cost management, geographic cost distribution, and ability to reach target price.
Performance is continually monitored for trends and thresholds across quality, delivery, compliance and risk metrics.
Supplier performance requires verified training, AVL/AML management, and adherence to compliance standards.
Propel's FAI process helps organizations reduce risk and drive consistent quality on manufactured parts by allowing evaluation of the manufactured part according to the design specifications and establishing clear acceptance criteria with the customer on the manufactured part.
In aerospace and defense, FAI is a critical requirement. Propel facilities recording of first production run results of a new or revised part using the out-of-the- box FAI flow. Propel enables capturing of inspection criterias, and part characteristics, along with sample sizes and inspection results. Traceability to the associated approved part revision is captured by design.
Propel enables tracking of further investigations when an FAI fails. New NCMRs can be launched on failed inspections to document containment actions, root causes and associated material dispositions.
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