What is Requirements Management | Oracle

How requirements management supports your industry

Requirements management for life sciences

This industry faces unique challenges from heavy regulation and long product-development cycles that entail massive investments in research and development. As an example, the cost of bringing a new drug to market has increased exponentially over the last several decades. All requirements (pertaining to regulations, packaging, patient needs, the intended use, and design) need to be managed by a systems-engineering or requirements management solution that is auditable, traceable, secure, and reportable.

With lean systems engineering and requirements management, medical-device companies can define product requirements clearly. This enables them to track patient needs to resulting medical device and therapeutic design, and thereafter to test cases and test results. Requirements and test management serve as the central information hub for all of the development and execution of data collection, verification, validation, tracking, and traceability mandated in this highly regulated industry. The aim is to help produce better medicines and devices that help people live longer, healthier, more active lives.

With a modern requirements management solution, Life Sciences companies establish scalable and secure solution architectures that benefit from streamlined and global market-registration regulations. Lean product-systems engineering gives pharmaceutical companies a single view of how formulations’ ingredients will be sourced globally and regulated throughout the supply chain. To support global market registration and ensure that regulatory standards are maintained throughout the development process, pharmaceutical companies need to ensure primary packaging requirements are managed in tandem with global product requirements.

Impacts of lean systems engineering in life sciences

• Structured process to monitor patient expectations
• Improved decision-making around product design, needs, and wants
• Reduced development cycles
• Improved quality of device-development design documentation
• Existing data leveraged to support platform strategies
• Traceability streamlined by providing the framework for validation and verification

Requirements management for high tech

This industry faces intense pressure to drive rapid innovation cycles, quickly introduce new products and be right to market. Growth is driven organically through the release of leading-edge new products, via acquisitions, and/or by moving into new geographical markets. High-tech companies’ products are becoming increasingly complex and are being driven through the IoT, model-based enterprise, model-based systems engineering, digital twins, and other leading supply chain management (SCM) practices.

To keep up with higher consumer expectations, companies need to invest in a systems-engineering/requirements management solution in the cloud. Systems-engineering mastery enables more efficient execution of I2C, from innovation through product development, release and commercialization. A modern requirements management solution will seamlessly integrate with innovation and subsequent product-development platforms, software-development solutions, and PLM/PDM (product lifecycle management/product development management) solutions architectures that provide new product information very early in the product lifecycle. Modern requirements and test solutions ensure that enriched and accurate product information is delivered to all stakeholders. Data verification and validation are vital to prevent expensive engineering change orders, scrapped products, or (in worst-case scenarios) poor-quality products entering the marketplace, given that a single quality issue can cause an entire product line to fail.

Impacts of lean systems engineering in high tech

• Structured process to establish requirements that can be tested and validated
• Improved decision-making around product design, needs and wants
• Reduced development cycles
• Use of existing data to support lean design practices
• Risk reduced through traceability, from initial requirements that are decomposed and fulfilled by design, and tied through to implementation and test

Requirements management for industrial manufacturing

This industry enables modern product development I2C flows that look to new models of interaction (cloud, mobile, IoT, social networks, analytics, and so on) to maintain leading-edge capabilities. Because of the inherent complexity of Industrial Manufacturing supply chains, innovation, product development, project management, and product commercialization must be seamlessly aligned from beginning to end.

Lean systems engineering (enabled by modern requirements and test management) streamlines industrial manufacturing processes by synchronizing information through innovation, product development, release, and commercialization. A modern requirements management solution can unify and standardize design processes. As products mature through the product lifecycle, an appropriate solution in the cloud ensures that the data is governed, verified, validated, shared, and enriched so that bad data can’t flow to downstream manufacturing and supply chain operations.

Impacts of lean systems engineering in industrial manufacturing

• Structured process to monitor patient expectations
• Improved decision-making around product design, needs, and wants
• Reduced development cycles
• Improved quality of device-development design documentation
• Existing data leveraged to support platform strategies
• Traceability streamlined by providing the framework for validation and verification

Requirements management for consumer packaged goods (CPG)

More than any other, this industry must deal with the large volume of options and variations in the products it produces. Increasing regulations and quality-control checks means that companies need a systematic requirements and test-management solution that provides strict change controls and governance, enabling higher customer satisfaction. The CPG industry must also be able to efficiently reuse previous requirements and testing, so it doesn’t reinvent the wheel.

A lean systems-engineering/requirements management application in the cloud helps centrally manage all aspects of requirements and test while distributing consistent and accurate data in channel-specific formats. With a modern lean systems engineering solution, CPG companies (especially fast-moving companies) define product requirements in a flexible and dynamic environment to ensure that market needs, packaging, and product requirements are being met. Speed and time to market are front of mind for this industry, and because requirements/test data is in the cloud, companies can access it from anywhere to ensure they get to market faster and reduce the manual processes and data entry that can lead to errors and increase overheads. This critical data can be reused to further decrease time to market and minimize the amount of scrap/waste.

Impacts of lean systems engineering in consumer packaged goods

• Flexible and dynamic process to establish requirements
• Improved decision-making around product design, needs, and wants
• Reduced development cycles
• Existing data leveraged to support lean design practices
• Costs controlled by continuous monitoring of product data
• Compliance risk reduced due to traceability from initial requirements that are decomposed and fulfilled by design, and tied through to production

Requirements management for aerospace and defense

This industry consistently drives design practices that look to new models of interaction (model-based enterprise, the IoT, digital twins, and so on) to maintain leading-edge capabilities. Aerospace and Defense companies are faced with increasingly complex electromechanical products that must perform in environments that cannot be easily serviced. The complete system being designed has many interlinked and interdependent parts that must be understood during the design and development process. Because of this, getting the right product to market means requirements must be clearly defined, managed, decomposed, tracked, and tested.

A lean systems-engineering cloud platform enables collaboration for system-level design through to subsystem definition, and into implementation and test across stakeholders from multiple disciplines (mechanical, electrical, software, and systems/test). Oracle’s platform provides unique traceability into and back from the PLM bill of material to the system-engineering processes and practices. The ability to manage early-stage requirements and their linkage and traceability through to their instantiation in PLM is critical in supporting systems-engineering best practices. Oracle’s cloud platform allows requirements to be tied into downstream processes, helping to shorten design cycle times, reduce costs, and increase product quality.

Impacts of lean systems engineering in aerospace and defense

• Standardized and established requirements authoring
• Increased product quality through complete product-readiness views to track requirements coverage
• Existing data leveraged to support lean design practices and the reuse of IP
• Risk reduced through traceability from initial requirements that are decomposed and fulfilled by design and tied through to implementation and test
• Ability to analyze the impact of requirement changes against required artifacts