Regulatory compliance is a critical aspect in the pharmaceutical industry, as this sector is subject to strict regulations. For this reason, companies must ensure that all their processes adhere to the correct standards to guarantee the safety and quality of their products.
In this context, having tools that facilitate compliance with these regulations is essential to avoid penalties, protect the company’s reputation and ensure the health of patients.
EHS Tracker is an indispensable ally for the pharmaceutical and medical device industry.
This platform is designed to adapt to the specific needs of each company, helping them to keep up with current regulations and international standards such as ISO-9001, ISO-14001 and ISO-45001.
That is why we will explain 5 key ways in which our platform ensures regulatory compliance in the pharmaceutical industry.
1. Adaptability to standards and regulations
Compliance with local and international standards and regulations is essential to ensure product quality and safety.
EHS Tracker is designed to meet the various regulatory requirements governing the pharmaceutical industry in the United States and Spanish-speaking countries such as Mexico, Puerto Rico, Colombia, Chile and Argentina.
The platform provides comprehensive support for local regulations such as FDA in the United States and COFEPRIS regulations in Mexico or INVIMA in Colombia, ensuring that companies comply with these specific requirements.
In addition, EHS Tracker contains functionality based on best practices outlined in recognized international standards such as ISO-9001, ISO-14001 and ISO-45001.
2. Real-time monitoring and reporting
In the pharmaceutical industry environment, constant monitoring of key indicators and accurate reporting are crucial to ensure compliance with strict regulatory standards.
EHS Tracker enables continuous tracking of pharmaceutical-specific regulations, as well as Good Manufacturing Practices (GMP) and US FDA requirements for electronic dossiers and signatures, among others.
This also includes the monitoring of controlled environmental conditions in drug production and storage areas to ensure product safety and efficacy.
3. Risk and safety management
EHS Tracker offers advanced tools that enable companies to identify and manage risks at all stages of production.
For example, it can identify potential risks in drug manufacturing processes, such as cross-contamination in production lines or failures to comply with Good Manufacturing Practices (GMP).
It also facilitates the implementation of appropriate safety measures to protect employees in potentially hazardous work environments, such as laboratories and chemical production areas.
4. Training and continuous development
EHS Tracker encourages ongoing education of employees on regulatory compliance issues, ensuring that they are trained and prepared to meet the requirements of the jobs they hold.
For example, the platform provides access to up-to-date resources such as manuals, policies, standard operating procedures (SOPs), work instructions, best practice guides (GMPs), educational videos and case studies.
These resources enable employees to stay abreast of changes in procedures and processes to continuously improve safety and quality in the workplace.
5. Integration with other systems
Integration with other systems is essential to optimize processes and ensure regulatory compliance.
EHS Tracker stands out for its ability to seamlessly integrate with other management systems and software used in the industry, facilitating data synchronization and improving coordination between different functional areas such as Human Resources, Purchasing, Finance, Maintenance and Manufacturing Automation.
To mention just one case, the platform can be integrated with ERP systems used for enterprise resource management, such as SAP, Workday, People Soft, Microsoft Dynamic, Oracle and others.
This integration allows an integrated management of data related to the production, inventory and distribution of pharmaceutical products, ensuring efficiency in the management of information between platforms.
Manage your drug chain with EHS Tracker
As you may have noticed, EHS Tracker is an indispensable tool for companies seeking to maintain high operational standards.
In addition, it offers standardized functionalities and at the same time it is a platform adaptable to the needs of each operation, which makes it an integral solution to face the challenges of the pharmaceutical sector.
If you would like more information about our platform, please fill out the following form and we will be happy to contact you.
