The First Comprehensive Compliance and QMS Solution Built on a Highly Flexible BPM Platform
Los Angeles, CA, March 20, 2017 — Intellect, a leader in Enterprise SaaS software providing Business Process Management (BPM) and Quality Management System (QMS) solutions, today announced Intellect QMS, a comprehensive product suite consisting of nine highly flexible and configurable QMS applications leveraging Intellect’s award winning BPM platform and industry best practices in quality, compliance and risk management. Intellect QMS provides a powerful and centralized system to effectively manage and improve quality and compliance, and enables organizations to easily modify applications to address new regulations as well as unique business requirements within their own organization.
“Intellect QMS is a natural expansion for Intellect,” said Romeo Elias, President and CEO of Intellect. “Many of our customers already use Intellect to address quality and compliance, and now new customers can be up and running faster than ever. We empower employees to work smarter and become more productive by offering technology that anyone can use since it doesn’t require software programming.”
Intellect QMS enjoys the significant advantage of being the industry’s first solution built on a BPM platform, which empowers non-programmers to configure, manage, and deploy business applications with no programming required. Intellect QMS customers can configure the QMS applications offered by Intellect to meet their exact needs, and easily create additional business applications to automate, digitize, and optimize a wide variety of business processes, all without programming. In addition, customers can continue to receive the latest upgrades and feature enhancements to the Intellect BPM Platform, even if they have configured the QMS applications to their unique needs or created an entire library of business applications.
Another key advantage of Intellect QMS is the availability of the solution in a native mobile app available on Apple and Android devices. Customers can launch the mobile app while in the field or on the factory floor, enter and retrieve data and access reports and tasks. In addition, the mobile app can be accessible even while offline, and will sync back with the back office when online again.
Intellect has been helping organizations meet their compliance and quality needs for over 17 years with their award winning Business Process Management platform. Many Intellect customers use the platform to address regulatory requirements, compliance, risk management, employee training, and much more. With Intellect QMS, Intellect now offers a suite of nine QMS applications that are ready for immediate use.
Intellect QMS – The Industry’s Most Configurable QMS Solution
Document Control
Enforce workflow and organize all quality documents into one centralized location, automate the routing, delivery, escalation, revision control, review reminder and approval of documents stored in a secure document repository to ensure quality and compliance.
Nonconformance
Create, track, and maintain accurate, auditable nonconformance records, assign follow-up tasks, enforce workflow, generate automated emails notifications and reminders to ensure accountability and task completion.
Complaints Management
Track the intake of customer complaints, enable continuous improvement, centralize record incidents, enforce workflow, and communication with customers to acknowledge, track, and implement any requirements to improve product quality, reduce product recalls, and ensure compliance.
Change Management
Improve transparency with automation, version control, and workflows in the change management process, submit change requests, empower employees to access change requests and updated design changes, and offer real-time notifications and validations for approvals, change executions, and implementations.
Corrective and Preventative Actions (CAPA)
Increase CAPA process efficiency with documentation, approvals, and decrease cycle time, digitize forms to streamline, automate, and standardize CAPAs, reduce audit time, improve quality, ensure safety, reduce product recalls, enforce workflow, and enable FDA, ISO and other compliance requirements.
Supplier Management
Manage the process of qualifying, selecting, and monitoring suppliers and supply chain partners, improve supplier transparency, avoid redundant evaluations, and define, track, manage, and report on supplier quality programs.
Audit Management
Prepare for and enforce audit related tasks, reduce risk, address internal audits to empower internal audit groups to determine key strengths and weaknesses with your process. Prepare for external audits by making quality manuals, performance improvement plans, training records, organizational charts, and the observation of processes easily accessible.
Employee Training
Leverage a single interface to develop and manage employee training initiatives, track and maintain a complete inventory of employee education levels, job descriptions, qualifications, and certification records. Develop employee skills internally, assign tasks based on skill level, and send auto reminders for new skill requirements.
Risk Management
Record and investigate risk management issues, incidents, and near-misses, and learn to prevent risk related issues. Track and communicate risk items in progress, define objectives, close out risk issues, and record resolution details. Continuously improve risk management with a risk reporting system, and empower employees to make smarter and safer business decisions.
Meeting Regulations
Intellect QMS enables organizations to address a wide variety of regulations, with a focus on FDA and ISO standards. Complying with the FDA is critical for many medical device companies, pharma, biotech, labs, and other manufacturers. Intellect QMS is designed to help organizations meet 21 CFR Part 11, 21 CFR Part 111, 21 CFR Part 210-211, 21 CFR Part 606, 21 CFR Part 820, and 21 CFR Part 1270-1271. ISO quality standards are used by most manufacturers and companies around the world to ensure that manufactured products meet customer and regulatory requirements. Intellect QMS enables organizations to adhere to a wide variety of ISO standards, including ISO 9001:2008, ISO 9001:2015, ISO 13485, ISO 14000, ISO 14971, ISO 15189, and ISO 17025.