About InflexionPoint
At InflexionPoint, we help companies harness the power of automation and data to make better decisions and operate more efficiently, safely, and effectively.
Contact Us
- HQ: 3535 Route 66, Neptune, New Jersey 07753
- info@inflexionpoint.ai
- +1-732-922-6611
Quality & Compliance
Manage Quality Arcoss Production
Digital Systems Enhance Quality and Compliance
You know you must consistently meet your quality standards and comply with all relevant regulations. How best to achieve those realted goals? (Please don't tell us you're still using a paper-based system.) A comprehensive digital Quality Management System is the answer. Increase quality and efficiency, while reducing errors and costs.
- Centralize documentation
- Increase visibility
- Simplify reporting
- Gather data for analytics
- Collaborate across teams
- Automate compliance
Independent Yet Integrated
We know Quality must act independently, while also forming a key part of an integrated production process, with links to ERP (Enterprise Resource Planning), MES (Manufacturing Execution System), PLM (Product Lifecycle Management), SCM (Supply Chain Management) systems. Our engineers build systems to automate the management of quality processes, support compliance with regulatory requirements, improve efficiency, and help maintain product safety and quality.
Ditch Paper. Go Digital.
Your processes can live in your QMS: document control, change management, training management, product management, deviation and nonconformance management, CAPA management, complaint management, audit management, supplier management, risk management, and equipment management, and more.
Training Management
Be sure your employees have the necessary skills and knowledge, and you foster a culture of continuous improvement. A QMS will streamline your training management, by automating tasks such as assigning training activities, sending notifications, conducting assessments, and tracking progress.
Adhere to Standards
There is certainly no shortage of standards: ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 820, ICH Q10, Good Manufacturing Practice (GMP), ISO 22716:2007, ISO 22000:2018, ISO/TS 16943:2009, AS9100D, to name a few. A QMS will help ensure you meet any chosen standards and applicable regulations.
CAPA and Audits
Corrective Action, Preventive Action (CAPA) and audits both follow a process of identification, evaluation, investigation, analysis, action plan, implementation, and follow-up. A QMS is ideal for storing checklists, documenting findings, and keeping records securely stored and easily accessible for review and analysis.
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Tell us your goals.
Do you have a Digital Transformation initiative? Need to upgrade your automation and controls systems? Wondering how you can become more data-driven? Let's talk.