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How can Pharma companies stay in control of their QMS?
The pharmaceutical industry is highly regulated, and compliance with regulations is critical to ensure patient safety and product quality. One of the regulations that pharmaceutical companies must comply with is the U.S. Food and Drug Administration’s (FDA) 21 CFR Part 11, which outlines the requirements for electronic records and electronic signatures used in FDA-regulated activities. Noncompliance with Part 11 can result in significant consequences, including product recalls, fines, and damage to brand reputation. However, digital solutions can help companies avoid Part 11 noncompliance and ensure compliance with regulations.
How can digital solutions help companies avoid Part 11 non-compliance?
1. Electronic Signatures
The Quality Solutions can provide a secure and compliant platform for electronic signatures, ensuring that all signatures are legally binding and meet the requirements of Part 11. The system should also have robust security measures in place to prevent unauthorized access or changes to electronic records.
2. Automated Data Management
A digital solution can automate data management processes, reducing the risk of human error and improving data accuracy. The system should also have audit trails and version control to ensure data integrity and compliance with Part 11.
3. Robust User Access Controls
The Electronic solution can provide robust user access controls, ensuring that only authorized personnel can access electronic records and electronic signatures. This includes user authentication and password policies, as well as role-based access controls.
4. Secure Storage and Retrieval
A digital solution can provide secure storage and retrieval of electronic records, ensuring that all records are available when needed and are protected against unauthorized access or modification.
5. Continuous Monitoring & Reporting
The GMP Compliance Solution can continuously monitor and report on compliance with Part 11, providing real-time insights into any noncompliance issues. This includes alerts and notifications for any noncompliance events, as well as reporting and analytics for compliance monitoring and audit purposes.
In the pharmaceutical industry, a Electronic Quality Management System (QMS) is critical to ensure compliance with regulatory requirements and maintain product quality. A EQMS System is a powerful tool that can streamline and automate processes, reduce errors, and increase efficiency. However, to get the most out of your Digital Quality Management software, it’s essential to stay in control of it.
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What are the ways to stay in control of your EQMS software:
1. Clearly Define Your Requirements:
Before implementing a Digital QMS System, clearly define your requirements and objectives. This includes identifying the processes you want to automate, the data you want to capture, and the reports you want to generate. This will help you select a software that meets your needs and ensure that you stay in control of the system.
2. Ensure User Adoption:
To stay in control of your QMS software, it’s essential to ensure user adoption. This includes training employees on the software, providing ongoing support, and creating a culture of accountability. When users are confident and comfortable with the software, they are more likely to use it correctly, reducing the risk of errors and noncompliance.
3. Regularly Review Your Processes:
Regularly reviewing your processes is critical to ensure that your Quality Management Solution stays effective and efficient. This includes identifying bottlenecks, areas for improvement, and potential risks. By continuously reviewing your processes, you can make informed decisions and stay in control of your QMS software.
4. Conduct Regular Audits:
Conducting regular audits is essential to ensure that your Electronic Quality Management System Software stays compliant with regulatory requirements. This includes reviewing electronic records, electronic signatures, security measures, and data integrity. Regular audits can help you identify any noncompliance issues and take corrective action promptly.
5. Stay Up-to-Date on Changes:
Conducting regular audits is essential to ensure that your EQMS software stays compliant with regulatory requirements. This includes reviewing electronic records, electronic signatures, security measures, and data integrity. Regular audits can help you identify any noncompliance issues and take corrective action promptly.
Staying in control of your Electronic QMS software is critical to ensure compliance with regulatory requirements and maintain product quality. By clearly defining your requirements, ensuring user adoption, regularly reviewing your processes, conducting regular audits, and staying up-to-date on changes, you can maximize the benefits of your QMS software and stay in control of the system.
In conclusion, a digital solutions can help companies avoid Part 11 noncompliance by providing secure and compliant electronic signatures, automating data management processes, providing robust user access controls, ensuring secure storage and retrieval of electronic records, and providing continuous monitoring and reporting. Implementing a digital solution can not only ensure compliance with regulations but also improve operational efficiency, reduce errors, and increase productivity, ultimately benefiting the company and the patients it serves
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