The Challenge

Today, challenges faced by product development teams include globalization, outsourcing, mass customization, fast innovation and product traceability.

Additionally, organizations are being asked to do more with fewer resources; product complexity is increasing while product lifecycles are compressing. Furthermore, to be competitive, manufacturers not only need to increase the rate of product innovation but also accelerate time to market, while tightly managing costs and relentlessly driving quality.

New product development challenges also include external factors such as product proliferation, consumer awareness, fast-moving consumer trends and changing government regulations. At the same time, manufacturers must comply with an increasing number of standards and regulations.

Equally important, interest in global product development is growing dramatically, driving new demands for distributed processes, collaboration, and global data management.

PLM systems are gaining acceptance for managing all information about the corporation's products throughout their full lifecycle, from conceptualization to operations and disposal. The PLM philosophy and systems aim at providing support to an even broader range of engineering and business activities.

PLM enables the entire design and supply chain to track, document, and report on important details including design intentions, considerations, test results, decision rationale, and compliance requirements within the context of the as-designed product configuration.

As the product definition evolves, PLM maintains the relationship between all the moving pieces as they change through multiple revisions. Everyone is synchronized on the current version and product designers can reconstruct the complete, versioned product definition (not just the BOM) at any point in time.

PLM provides process support beyond the focus of ERP, giving product managers the change control mechanisms they need to ensure consistent review and approval and to demonstrate due diligence against evolving regulatory compliance and quality standards. They control the change process itself, instead of simply phasing the finished product into production after all decisions have been made.

Because PLM serves as the core product information management system, it complements ERP systems by synchronizing production systems on a single version of the product record across the extended enterprise.

Think of PLM as both a central data hub for all information that affects a product, and a communication link between marketing, engineering, manufacturing and field service. Your PLM system is where all product information from marketing and design comes together, and where it leaves in a form suitable for production and support.

The Solution

ISOSYSTEM Product Lifecycle Management (PLM) is a solution that provides the necessary requirements and capabilities companies need to successfully manage information and facilitate communication and collaboration across the entire product lifecycle from its conception, through design and manufacture, to service and disposal. In addition, ISOSYSTEM also helps manufacturing engineering companies to develop, describe, manage and communicate information about their products (PDM).

ISOSYSTEM provides a centralized product development database which helps you eliminate effort duplication by maintaining other product information such as costs, characteristics, specifications and development status in a single place.

ISOSYSTEM also helps enforce consistent product development procedures and policies, eliminating confusion and lost time working "against" the process. With an integrated workflow system ISOSYSTEM allows you to easily determine where a process is held up. And, by providing a complete audit trail for changes, you can also save time searching to find what data was changed, by whom, when and why.

Some of the benefits organizations may expect with ISOSYSTEM include:

• Reduced prototyping costs
• Reduced engineer cycles through re-use of master data
• Reduced rework and waste
• Improved product quality
• Reduced time to market
• Gain on processes conformity
• Improved productivity
• Better use of equipment assets

By adopting ISOSYSTEM as their PLM solution organizations can be rest assured that their products will be aligned with their business strategy, which will help them to manage the complex challenges associated with bringing new products to market.

Most importantly, ISOSYSTEM enables organizations to improve overall quality and reduce costs and risks associated with a growing number of regulatory compliance and corporate governance processes such as those related to the ISO 9000 Quality Guidelines, Sarbanes-Oxley, FDA 21CFR Part 11 Electronic Record Keeping, Good Manufacturing Practices, OSHA Regulations, and others.

Related Products

Related Regulations

FDA 21 CFR Part 11
ISO 9000
OHSAS 18000
SOX

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