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NovaQuest solutions help companies in the Life Sciences industry navigate the course to government certification during the development of potentially life-saving products and technologies. Fierce global competition is exemplified with the realization that often only the first-to-market products become blockbusters. Additionally, global development and the international supply chains that result repeatedly introduce companies to new sets of rules. To stay on course, Life Sciences companies today have discovered the guidance they need is available from product lifecycle management (PLM).
At NovaQuest, we’ve derived superior industry solutions by leveraging our unique combination of real-world industry experience and deep knowledge of PLM applications delivered by Dassault Systèmes (DS). NovaQuest is the first DS partner to offer new V6 PLM technology which combines the advanced collaborative business processes of ENOVIA, the knowledge-driven development of 3D in CATIA, and the lifelike experience of 3DVIA to help your company reach new levels of product and process innovation. Our solutions enable:
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Collaborative Design Engineering to streamline design in a compliance-driven environment that naturally extends into supplier partners during development. |
CAD Data Management enables designers around the world to manage and collaborate from one application, no matter what design tools they are using. |
Key Capabilities:
- Strict electronic audit trails reduce risk by enforcing and maintaining regulatory compliance
- Automatic recording of electronic records and signatures lower the cost of compliance
- Manual effort eliminated with electronic documents routed virtually for signature approval
- Super-accurate and fully-detailed master records improve launch velocity
- Centralize CAD data management for worldwide design teams regardless of the authoring tools they use
Solution Benefits:
- Reduce or eliminate excess and obsolete inventory write-offs by planning components upfront and communicating changes earlier
- Achieve greater price reductions through more organized supplier selection and larger volume purchases
- Elevate strategic suppliers by offering direct access to development details online directly from ENOVIA
- Reduce component tooling costs by minimizing late-stage design changes and incorporating supplier feedback throughout component design
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Compliance Change Management to proctor ultra-efficient change procedures while ensuring the proper level of control |
Effective change control provides the ability to manage the different stages of a document’s maturity from release, revision and finally obsolescence. |
Key capabilities:
- Precise change procedures ensure the status and approvals of every design and document are defined
- High system rigor and efficiency handles multiple scenarios, thousands of people, and millions of documents
- Strict control over process change boards without the needless rigidity inherent to finally enacting change
Solution Benefits:
- Cost of compliance is reduced when governing processes are easy to follow and automatically enforced
- Cost of change is reduced through a flexible system easily configured to the latest regulations
- Change errors are avoided when the system guides users along the proper routes to approval
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Compliance Quality & Issue Management tuned to address quality problems immediately and administer issue resolution within an infrastructure of strict controls and accountability. |
Ensure that quality issue investigations are thorough and complete through rich features such as risk assessment, Six Sigma-based root cause analysis and the ability to connect supporting evidence. |
Key capabilities:
- Automatically links product data with trial experiments to remove drag from new product introduction
- Real time data visibility regardless of information lifecycle status produces faster response to opportunity
- “Single version of the truth” and rapid recovery of pertinent details minimizes audit effort and cost
- Wizards and system generated data automate completion of regulatory forms resulting in fewer mistakes
Solution Benefits:
- Reduce risk of penalties by addressing complaints with high-quality, consistent, and rapid responses
- Lost margins recovered with fewer complaints, penalties, and costly formal reviews and audits
- Reduced cost to maintain CAPA certification under FDA regulation through stringent process adherence
- More satisfied customers as represented by fewer complaints and faster complaint resolutions
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Collaborative Product Launch built within an organized and repeatable project environment that provides ready access to data and deliverables. |
Visual dashboards that list the deliverables required at each stage of a project to enable a project team member to identify which deliverables are required and their status. |
Key capabilities:
- Project templates inject years of knowledge and experience into every new plan for fast project ramp-up
- Documented workflows and ad hoc processes clearly guide employees to make everyone more successful
- Quick delegation of task deliverables backed by clear accountability accelerate innovation
Solution Benefits:
- Financial performance improves when slow manual processes that delay innovation are eliminated
- Launch efforts yield higher returns when applied to innovation rather than rote data entry and arduous processes
- Time-to-margin is reduced with shorter product launch periods and fewer costly startup problems
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To request more information on these solutions, please contact a NovaQuest representative today!
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