The prescription for digital compliance
Compliance with 21-CFR-820 and 21-CFR-11 regulations provide both an opportunity and a challenge for Medical Device companies.
The challenge is to automate and modernize manual and semi-automated regulatory and audit activities to reduce the risk and potential impact to the business while continuing to address numerous competitive pressures. The opportunity is to envision the integration of PLM-enabled processes as the fabric that weaves quality management and innovative product development into a mutually reinforcing technology foundation to drive innovation achieve business success.
Integware is a recognized leader in helping Medical Device companies automate compliance, accelerate innovation, reduce product development costs, and drive business strategic development.
Integware can help medical device companies address critical business issues with our deep experience in deploying integrated Product Lifecycle Management solutions. Our focus on strategically-inspired deployment ensures that:
- Regulatory compliance and time consuming audit preparation activities form the basis for a state/gate product development lifecycle solution that manages all project deliverables enabling automatic Device History File (DHF) presentation and process compliance.
- Pragmatic and efficient automating, optimizing and integrating of inter-related processes such as change management and document management reinforce basic quality process excellence initiatives helping organizations achieve the competitive edge by slashing time to market by 40% or more. These solutions allow the organization among other things, to eliminate bureaucratic activity as well as measure the process and identify bottlenecks.
- Automation of Device Master Record (DMR) allows any new team or team members to rapidly gain knowledge of the entire definition of a product, including structure of the BOM, related CAD information, specifications, and manufacturing processes reducing the reliance on tribal’ knowledge or processes that inhibit effective demand-driven product development.
Quality and innovation are key to remaining competitive, compliant, and avoiding costly adverse events such as recalls. By bringing product knowledge and processes together into an Integrated PLM platform it is easy for team members to access the most current information needed avoiding costly guess work and mistakes. Additionally, it's easy for product teams to quickly identify problem areas of design by linking process information for any adverse events that do arise back to product definitions.