Meet Compliance Standards and Solve Technical Challenges Quickly and Efficiently
Companies are rapidly shifting from relying on hardware to relying on software for the innovations that differentiate their products in the market. This shift has presented a number of challenges that Windchill RV&S (PTC Integrity), a single, enterprise product, delivers solutions for including:
Compliance is a topic that continues to grow in relevance across a wide set of industries. In industries where safety is critical, new functional safety standards—such as ISO 26262 in automotive—continue to emerge. Company’s must take these standards very seriously and cannot let them impede productivity, time-to-market or increase development costs. Windchill RV&S (PTC Integrity) offers compliance solutions for several industries including:
|Challenge||Windchill RV&S (PTC Integrity Lifecycle Manager) Solution||Benefits|
|Challenge||Management of Documentation and Records||Solution|| ||Benefits||Reduce effort to create DHF from weeks to minutes|
|Challenge||Identification and Traceability||Solution|| ||Benefits||Significant time savings|
|Challenge||Document Controls and |
|Solution|| ||Benefits|| |
|Challenge||Managing Risk and |
|Solution|| ||Benefits|| |
The FDA and ISO 14971:2007 both acknowledge that the use of medical device technology entails some level of risk. The goal of risk management is to reduce product risk and to identify and understand the level of remaining risk and the impact that has on the user’s safety and the effectiveness of the product. Windchill RV&S (PTC Integrity) provides a configurable framework to apply the risk management practices of ISO 14971:2007 which allows organizations to improve the safety and effectiveness of their devices and enables them to demonstrate regulatory compliance. The benefits of using Windchill RV&S (PTC Integrity) for risk management of medical devices include:
RTCA DO-178B and EUROCAE ED-12B set rigorous safety standards on the commercial aerospace industry governing both the quality of the flight software embedded in aircraft and the processes and tools used to produce the software. The standards require engineering organizations to implement lifecycle processes that emphasize requirements-based development and independent verification for safety-critical embedded applications. Strong emphasis is also placed on change and configuration management as the basis for repeatability, traceability, and third-party reviews. Further, organizations must apply these processes uniformly across all product development lifecycle artifacts, from requirements to test plans and results, rather than simply to software configurations.DO-178C/ED-12C:
There are numerous updates and enhancements included in DO-178C/ED-12C. Among them are modernization of the standards to address newer development methods such as model-based development, object-oriented technology, and formal methods. The new standards also provide more comprehensive guidance on tool qualification across the lifecycle, including practitioner tools used to automate the new practices already mentioned.Organizations already using Windchill RV&S (PTC Integrity) to unify the lifecycle have been able to adapt to the additional requirements of the ‘C’ revisions with less disruption because they already have an integral view of all lifecycle information. They also find it easier to adopt newer methods, such as model-based development, adapting their lifecycle processes to meet certification requirements associated with the new methods using Windchill RV&S (PTC Integrity)’s single, integral data model and workflow engine.
Certification agencies, Designated Engineering Representatives (DERs), manufacturers, and suppliers are facing numerous challenges as they attempt to adapt to the relentless pace of change in the industry. Certification and qualification processes that were sufficient just a decade ago are failing to address the industry shift to software-driven innovation. Among the many challenges the industry is struggling to solve:
Windchill RV&S (PTC Integrity) addresses the challenges of DO-178/ED-12:
Windchill RV&S (PTC Integrity) enables engineering organizations to solve these challenges by providing a single, integral source of truth for the entire engineering lifecycle, including software artifacts. It is purpose-built to enable tracking of change, configuration, and traceability across all lifecycle artifacts in a single data model. Tool suites built by lashing many point tools together fail to provide the same comprehensive visibility, control, and tracking across all lifecycle artifacts, leaving the organization to collect the information needed to satisfy the standards from multiple sources which often overlap in some areas and leave gaps in others — resulting in an incomplete and inconsistent view of the lifecycle.
International standards such as ISO 26262, a new functional safety standard for the automotive industry, provide frameworks to improve company policies, practices and processes. Public perception and government regulations compel automotive development organizations to adhere to the relevant standards. While these standards are an opportunity to improve process and product quality and safety, they also impose risks to cost efficiency and development cycle time. The ultimate responsibility for compliance is on the vehicle manufacturer. Thus a higher capability level in CMMI or Automotive SPICE and ISO 26262 compliance gives suppliers significant competitive edge.
Implementing standards can be time-consuming and expensive. It has been estimated that complying with ISO 26262 may cost the automotive industry hundreds of millions of dollars. This is further complicated by the global and differentiated development environment of today’s automotive industry; applying standards to processes and artifacts across multiple isolated systems and disciplines is a daunting task.
Automobile engineering companies have turned to PTC Integrity as a compliance solution certified by compliance certification bodies such as TÜV SÜD Automotive GmbH. The following are examples of capabilities provided by PTC Integrity that have reduced the cost and the time required to implement and prove compliance:
PTC has been a trusted partner to leading OEMs and suppliers in the automotive industry for more than ten years. Our customers have been able to reach and demonstrate compliance in the following standards quickly and efficiently:
CMMI is an industry standard for systems engineering, integrated product development, software engineering and supplier sourcing maturity. The flexible process and workflow capabilities of Windchill RV&S (PTC Integrity) enable companies to easily evolve through maturity levels, while our partners and professional services staff can provide ongoing assistance to companies moving up and through the various levels toward CMM certification from performed to optimizing
With the enactment of Sarbanes-Oxley (SOX) and other compliance initiatives, software and tools designed to automate the process of compliance have become a necessity. By automating compliance with application lifecycle management, organizations can meet compliance demands without the costly diversion of financial and human resources. Organizations benefit over the long term by creating leaner and more focused business processes and improving development controls.
Windchill RV&S (PTC Integrity) links application development to your data center. Our industry-certified solution for ITIL provides support for change, configuration and release processes and directly links them to processes found in the development phase of the application lifecycle. Windchill RV&S (PTC Integrity) is the only product to provide a single platform that spans the process needs of IT operations and application development, giving you a way to improve process control, traceability and visibility from system inception to delivery, and across custom and packaged software environments.
You are seeking a way to extend ITIL processes, provide vital links to development, and improve IT governance. You are seeking a solution that serves your business entirely, providing unified process control across IT operations and application development. And, you want to eliminate barriers to communication and collaboration that inhibit speed of delivery.
Windchill RV&S (PTC Integrity) provides an integrated platform that harmonizes the disciplines of ALM and IT Service Management, providing you with:
Windchill RV&S (PTC Integrity) is an open platform, completely adaptable into existing technology environments. Key integrations into various Service Desk, Asset Tracking and Discovery applications are available as part of the solution.
Windchill RV&S (PTC Integrity) can be implemented for application service management in conjunction with your existing IT operational technologies including, but not limited to:
Continuous Integration and Continuous Delivery are key Agile concepts that enable organizations to improve the quality of the applications delivered to operations from the development group. These concepts can make life even harder, however, for the operations group that typically struggles with the deployment of complex multi-platform modern applications.
It is imperative that the relationship between these groups becomes more collaborative (a key Agile tenet) for these highly iterative processes to flourish. It is also critical that these processes are automated such that the hand off from Agile ALM processes to Release Management and ITSM processes is coordinated, secure, and essentially incorruptible.
Windchill RV&S (PTC Integrity) provides the platform necessary to easily automate Agile and traditional release processes, ensuring consistent and rapid deployments of your applications. The Windchill RV&S (PTC Integrity) Agile solution is ideally suited to addressing the process and control needs of an organization trying to reconcile ITIL and Agile practices.