Intellect

A Smarter Quality Management Software Solution

Intellect provides a highly configurable enterprise Quality Management Software (eQMS) solution and platform to enable organizations to achieve compliance and digital transformation. Intellect eQMS is a highly configurable, comprehensive, and integrated suite of eQMS applications that includes document control, nonconformance, corrective and preventative actions (CAPAs), complaint management, change management, supplier management, audit management, employee training and risk management. Built on top of the award-winning Intellect Compliance Platform, all Intellect eQMS apps can be easily modified to address an organization’s unique business and regulatory requirements.

With the Intellect Compliance Platform, users can build new business applications to automate virtually any business process. Our no-code platform enables non-programmers to develop forms, workflows, and reports that are an exact match with their business need today and in the future.

Intellect can be configured to meet any FDA regulation, ISO standard, or many additional compliance requirements. However, we believe in going beyond compliance, and achieving better performance with true digital transformation.

Case Studies

Siliker

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Audit Management & Dashboard

Real-time metrics to analyze your business performance.
Customizable reports that deliver relevant data to your users.
Detailed overview of all your quality apps in one place.
Prepare for and enforce audit related tasks and activities to ensure compliance.

Reduce risks by enforcing consistent and harmonized processes and procedures while securely management all information in a centralized, scalable and reliable system.
Address internal audits to empower internal audit groups to determine key strengths and weaknesses with you process.
Prepare for external audits by making quality manuals, performance improvement plans, training records, organizational charts, and the observation of processes easily accessible.

Calibration & Maintenance, Corrective & Preventive Action

Manage your equipment to ensure optimal performance of your assets.
Automate calibration and maintenance schedules to address resource, workload or manufacturing constraints.
Track uptime and downtime across weeks, months, quarters or years.
Increase CAPA process efficiency, including documentation, approvals, and signatures to decrease cycle time and operation costs.

Digitize process and forms to streamline, automate, and standardize the implementation of corrective and preventive actions (CAPAs).
Reduce audit time and findings, improve product quality, ensure safety, reduce product recalls, and enable FDA, ISO and other compliance requirements.
Reduce the risk of lost data and repeat issues by ensuring that defined CAPA solutions and processes are met.
Customizable analytics and reporting to understand trends and solve problems, improve processes, and implement new preventative measures.

Change & Complaint Management

Improve transparency with automation, version control, and workflows in the change management process.
Submit change requests and control plan revisions at any point in the production process and track all revisions.
Empower employees with access to change requests, process flow alterations and updated process and design changes.
Real-time notifications and validations for approvals, change executions, and implementations.

Track the intake of customer complaints through investigations, CAPAs, and effectiveness checks to minimize the risk of product and regulatory issues.

Enable continuous improvement with an easy-use-solution that works on any device, including mobile devices that require offline capabilities.
Centralize record incidents, facilitate investigations, report results, and close cases.
Communicate with customers to acknowledge, track, and implement any requirements to improve product quality, reduce product recalls, and ensures compliance.

Deviation Management & Document Control

Manage Planned and Unplanned Deviations stay compliant with standards and regulations.
Automate data collection, routing, follow-up and increase of deviation.
Avoid the reoccurrence of deviation.
Organize all documents into a centralized database with approval workflows and audit trails.

Customize your document controls and workflows to address your unique quality process requirements.
Automate the routing, delivery, escalation, revision control, and approval of documents stored in a secure document repository to ensure quality and compliance.
Eliminate redundancy, reduce the risk of manufacturing products, create efficiency in organizing documents from suppliers and others.

Employee Training & Feedback Management

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.
Maximize the effectiveness of developing employee skills internally, assign tasks based on skill level, and send auto reminders for new skill requirements.

Become more lean and efficient as your organization understands what training and skills are in-house and what new competencies are required.
Capture suggestions from end users for customizing eQMS to your company’s unique needs.
Score suggestions on three characteristics for your eQMS improvement roadmap.
Route suggestions for approval.

Risk Management & Nonconformance

Record and investigate risk management issues, incidents, and near-misses, and learn to prevent risk related issues.
Track and communicate risk items in progress and define objectives in one central system.
Continuously improve with a risk reporting system and close out risk issues and record resolution details.
Generate custom risk reports to empower employees to make smarter and safer business decisions.

Create, track and maintain accurate, auditable conformance records.

Ensure compliance with all management records.
Assign follow-up tasks for corrective and preventive actions (CAPA) to employees in nonconformance.
Automated email notifications and reminders to ensure accountability and task completion.

Supplier Management, Validation, & Verification

Manage the process of qualifying, selecting, and monitoring suppliers and supply chain partners.
Improve the efficiency of your supplier network with workflow, automation and transparency.
Avoid redundant evaluations of all previous suppliers evaluated complete records for reference.
Define, track, manage, and report on supplier quality programs and progress to increase the efficiency of the supplier ecosystem and network.

Demonstrate your Product, Process or System can fulfill specified requirements.
Significantly reduce your validation cycle cost and time,
Increase compliance by reducing non- value-added activities.

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