Intellect QMS 4.0 is the latest version of Intellect's flagship product designed to help organizations and quality leaders meet FDA, ISO, and other global GxP regulatory compliance requirements. Intellect offers faster implementation time, robust out-of-the-box QMS capabilities, and extreme configurability to modify or build new apps.
Empower your onsite and remote workforce with virtual auditing, online approvals, 21 CFR Part 11 electronic signatures, and ensure your team can access only approved and up-to-date quality documents, data, reports and analytics anytime, on any device.
✓ Prepare for and enforce audit related tasks and activities to ensure compliance.
✓ Reduce risks by enforcing consistent and harmonized processes and procedures while securely managing all information in a centralized, scalable and reliable system.
✓ 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.
✓ 8D problem solving methodology used to facilitate continuous improvement, through identifying, classifying and eliminating existing or potential nonconformances in product, processes, and system
✓ Establish the mechanism to perform of finding the root cause of a problem, devise a short-term fix and implementing a long-term solution to prevent recurring problems
✓ Establish CAPA Review Board team to review and approve corrective actions
✓ 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.
✓ 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.
✓ Establish the mechanism for documenting, investigating, evaluating, and dispositioning reported customer complaints.
✓ Perform process and product evaluation to determine if product is performing as intended or remedial actions need to be taken to eliminate existing or potential nonconformance in product and processes.
✓ Communicate with customers to acknowledge, track, and implement any requirements to improve product quality, reduce product recalls, and ensures compliance.
✓ Conduct thorough quality investigations using various quality tools and escalate to new or existing nonconformance OR corrective actions (CAPA).
✓ 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.
✓ 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.
✓ Establish the mechanism of identification, evaluation, resolution, and documenting the risk and occurrence of nonconformance affecting product, process, and quality system
✓ Perform identifying, controlling, segregation and disposition of non-conforming material identifying, controlling, segregation and disposition of non-conforming material
✓ Generate Supplier Corrective Action Request (SCAR) as a result of nonconformances related to products and/or services provided by Suppliers
✓ Automated email notifications and reminders to ensure accountability and task completion..
✓ 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.
✓ 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.