Key Capabilities for Stress-Free Compliance and Control
Create a Single Source of Truth
Centralize all critical documentation, accelerating approval cycles and ensuring every team member works with the latest, compliant revisions. This prevents costly errors, improves data integrity, and reduces audit preparation time by providing a reliable source of truth across the enterprise.
Reduce Preventable Errors by Building Competence
Link training directly to the latest procedures to simplify onboarding and track coverage. Minimize the risk of non-compliance and operational mistakes due to personnel not being trained on new versions, enhancing productivity and reducing potential liabilities from human error.
Neutralize Threats Before They Occur
Systematically identify, assess, and prioritize potential risks across your operations by integrating evaluation in key processes. Develop and document mitigation strategies, reducing the likelihood of costly issues, product failures, and reputational damage.
Continuous Compliance Through Simplified Audits
Leverage this closed-loop system for scheduling, managing findings, and integrating with nonconformances. Centralized information and streamlined workflows significantly reduce preparation time, ensure regulatory adherence, and provide indisputable proof of compliance.
Key Capabilities for Stress-Free Compliance and Control
Create a Single Source of Truth
Centralize all critical documentation, accelerating approval cycles and ensuring every team member works with the latest, compliant revisions. This prevents costly errors, improves data integrity, and reduces audit preparation time by providing a reliable source of truth across the enterprise.
Reduce Preventable Errors by Building Competence
Link training directly to the latest procedures to simplify onboarding and track coverage. Minimize the risk of non-compliance and operational mistakes due to personnel not being trained on new versions, enhancing productivity and reducing potential liabilities from human error.
Neutralize Threats Before They Occur
Systematically identify, assess, and prioritize potential risks across your operations by integrating evaluation in key processes. Develop and document mitigation strategies, reducing the likelihood of costly issues, product failures, and reputational damage.
Continuous Compliance Through Simplified Audits
Leverage this closed-loop system for scheduling, managing findings, and integrating with nonconformances. Centralized information and streamlined workflows significantly reduce preparation time, ensure regulatory adherence, and provide indisputable proof of compliance.
Customer Success Stories
View All Customer Stories
This Michigan manufacturer collaborates on quality with 100 suppliers
“Foundational libraries ensure that the knowledge we have for all our processes is utilized on every single product we implement”
Medical imaging manufacturer sees quality clearly with QAD EQMS
“Our auditor really enjoys seeing everything all centralized in one tool,” it raises the confidence level.”
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Frequently Asked Questions
What is the link between Document Control and Training Management?
In QAD EQMS, the Document Control and Training Management modules work together to ensure employees are up-to-date with the latest procedures. This integrated system links training directly to the most current documents, so when a change is made, the system automatically identifies and addresses the corresponding training needs for relevant personnel. Manufacturers in the medical device and automotive industries leverage this connection to maintain compliance with standards such as ISO 9001, IATF 16949, and others. It streamlines the process of updating documents and training employees, reducing manual effort and errors, and ensuring a single source of truth.
What standards does QAD EQMS address?
- ISO 9001 (Quality Management System): EQMS helps organizations meet ISO 9001 requirements for quality management, making compliance easier. Analogic, for example, relies on EQMS to adhere to quality standards and support continuous quality improvement.
- ISO 14001 (Environmental Management System): The system also supports compliance with ISO 14001 for environmental management.
- ISO 31000 / ISO 14971 (Risk Management): EQMS assists with risk management, aligning with ISO 31000 and ISO 14971 for industries like Life Sciences. It helps prepare risk assessments, define likelihood and consequences, document controls, and develop treatments to mitigate risk.
- IATF 16949 (Automotive Quality Management System): For the automotive industry, EQMS supports IATF 16949, a crucial quality management standard. Autokiniton has aligned its quality initiatives with automotive standards like IATF 16949 using EQMS.
- ISO 13485 (Medical Devices Quality Management System): In life sciences and medical devices, EQMS offers capabilities to meet ISO 13485 requirements. Analogic, a leader in medical imaging systems, trusts QAD EQMS to maintain the highest standards in manufacturing for their digital mammography and imaging detectors, where rigorous medical device sector standards are critical.
- FSSC ISO 22000 (Food Safety): For the food and beverage industry, EQMS addresses FSSC ISO 22000 for food safety.
- HACCP (Hazard Analysis and Critical Control Points): The system includes capabilities to support HACCP, relevant for food safety and other industries.
- ISO 45001 (Occupational Health & Safety): EQMS also supports ISO 45001 for occupational health and safety.
- QS9000: Autokiniton implemented QS9000, an early quality standard for the automotive industry, and began using QAD EQMS for quality initiatives the following year.
- MMOG/LE (Materials Management Operations Guideline / Logistics Evaluation): This supply chain standard is supported by EQMS.
- AIAG/VDA Design and Process FMEAs: EQMS provides library-driven FMEA/Risk Analysis and supports AIAG/VDA Design and Process FMEAs, which are essential for automotive industry standards and quality planning. Autokiniton leveraged EQMS to develop standardized process libraries for FMEAs and control plans to ensure compliance with customer mandates, including those from major automotive manufacturers like Ford.
- 21 CFR (QSR) Part 820 (FDA Quality System Regulation): In life sciences, EQMS training tracking capabilities meet requirements such as 21 CFR (QSR) Part 820.
- cGxP - DHF/DMR (Good Practices, Design History File/Device Master Record): EQMS supports cGxP and specific documentation requirements like DHF/DMR, particularly relevant in the life sciences sector.
- GMP (Good Manufacturing Practice): The system also addresses GMP requirements