Integware Services
Integware is a world leader in helping medical companies optimizes their Product Lifecycle and Quality Management System.
“Helping companies improve patient outcomes“.
What kind of problems do our customers face?
Below are examples of the business challenges our customers face:
- “I can’t get my products to market in a timely manner”
- “We scrap raw material and unfinished goods due to avoidable mistakes”
- “Our cost of goods sold is too high”
- “People make changes without correctly understanding the impact”
- “I had to recall a product / 483 / Warning Letter”
- “Global sites cannot share information or collaborate effectively”
- “Teams or individuals cannot easily locate product information”
- “Product information is disjointed”
- “Our processes are poorly defined and/or executed”
- “We waste a lot of time looking for information”
- “I am concerned about the FDA or other agencies”
What kind of benefits does Integware bring?
Integware is skilled and passionate about the transformational benefits we can bring by helping your organization solve these challenges. By doing this companies have been able to achieve the following business benefits:
- Reduce operational costs: Integware helps companies cut costs incurred in the design and manufacturing process enabling sustainability throughout the entire product lifecycle. For example, by using the solutions we provide companies are able to cut down manufacturing scrap, rework and inventory. Companies have been able to cut considerable paper work and processing of information between functional departments and are able to eliminate unnecessary rework and engineering change orders. In addition, the integration between PLM and ERP ensures that information flow between the two systems takes place real time, reducing inventory level of quarantined products.
- Build safer and more effective products, improve revenue and competitive position: Integware helps medical device organizations improve their revenue by enabling and facilitating the process of innovation and break-through product development. We achieve this in multiple ways. First, by giving more time back to those responsible for product innovation and second, by ensuring information is made accessible to those involved in product iteration and ideation.
- Enable compliance with government regulations and ISO standards: This includes 21 CFR Part 820, Part 11, ISO 13485 and others. Integware’s customers have seen a rapid transformation, going from a Quality Management System (QMS) in disarray to a clean dependable quality system resulting in diminishing audit preparation time and audit issues. This has greatly reduced the risk of 483s, warning letters or even product recalls or plant closures.
- Improve operational and product lifecycle efficiency: Integware helps companies eliminate unnecessary or manual steps in business processes, integrate information flows and bring a best practice approaches to achieve lean product development and sustainability.
- Globalize the Organization: Many medical device organizations have global operations. This is usually a major undertaking and comes with many challenges such as how to streamline and optimize the value chain within, and external to the organization. By optimizing the product lifecycle and quality management system, Integware helps our customers achieve critical globalization goals.
How can you achieve these benefits?
First and foremost Integware has 20 years of experience delivering world-class PLM and QMS systems. In addition, we also bring process and QMS expertise to help organize and optimize the quality system and product lifecycle. Not all of our clients take the step to automate, but most do. Either way we can help companies achieve these breakthrough benefits.
There are many companies that provide only QMS consulting, QMS assessments, Gap Analysis, Audit Readiness, etc. and many others that provide technology implementation expertise (document management automation, QMS automation, PLM automation). Integware has the ability to provide both sides in an integrated plan for QMS and PLM optimization.
Integware is able to achieve this as we have specialized in the medical device industry for over ten years. Many of our expert consultants bring considerably more years of experience as well and Integware has developed deep domain expertise across the board from the initial QMS and product lifecycle design, through basic to state-of-the art fully automated and integrated solutions.
This allows us to develop the optimal product lifecycle and QMS system from the ground up. Or, if your organization has already performed some of the work we can help take it to completion and help with more specific steps along the way.
To keep pace with the increasingly competitive and cost-conscious nature of the medical device industry, it is essential to be prepared to scale the QMS. To do this, the entire product lifecycle and its Quality Management System must be evaluated against industry best practice processes. It must support and not prohibit automation or make automation too expensive. The technology decision will be driven from the business needs. The automation solution will as a result be very customer specific, whether those include basic automation tools and/or advanced state of the art PLM system.
Integware believes fully in using out-of-the-box tools avoiding the need for heavy configuration or customization and as such we seek out the best-in-class tools that offer medical device specific capabilities and best practices. We bring expertise in the leading PLM platforms and seek out the most optimal solutions for the industry. Whether you need a quality system optimization through paper process redesign or a fully optimized, integrated and automated QMS and Product Lifecycle Management system Integware can help.