Complying with regulations in the pharmaceutical and healthcare industries can be a complex and challenging task. Strict guidelines such as GDP and GMP dictate how drugs must be stored and transported, with the goal of ensuring product quality and safety. This requires reliable processes and detailed documentation.
Dyzle understands these challenges and offers solutions to make regulatory compliance easier. In this article, you can read about what regulatory compliance means, how you can stay compliant, and how Dyzle supports you in doing so.
What does complying with regulations mean?
Regulatory compliance means complying with all relevant laws and regulations within your industry. In the pharmaceutical and healthcare industry, for example, this means that you comply with GDP and GMP guidelines, which set strict requirements for the storage and transportation of drugs. It is not enough to say that you comply with these guidelines; you must be able to demonstrate this with a documented and approved quality system.
Companies with a GDP or GMP license must comply with GxP guidelines, including validation of processes, systems and equipment. Without a properly established and maintained quality system, the risk of deviations or noncompliance is high, which can have both operational and legal consequences. Accurate and documented practices are therefore essential to ensure quality and reliability.
How do you stay compliant with regulations?
Maintaining regulatory compliance is an ongoing process, with regular validation and risk assessment at its core. An effective quality system must be supported by documented processes and procedures. In addition, validation is required to demonstrate that systems and materials are working as intended.
This can seem complicated, especially if regulatory compliance is not part of your core business. Dyzle’s solution helps you simplify this process. By leveraging our proven solutions and support services, you can focus on your core business while complying with all regulations.
How can Dyzle support you?
Dyzle’s temperature monitoring is specifically designed to meet the stringent requirements of GDP and GMP guidelines. We provide all necessary documentation, validations and support to ensure your compliance with regulations. We also offer additional services to help you maintain the validated status of your processes and systems.
Our solutions are fully documented, tested and validated. When changes occur, we provide all necessary reassessments and documentation, so you are always assured of compliance. This not only saves time, but also minimizes risks associated with non-compliance.
Dyzle has already made the first step to validation for you. Request a ready-made User Requirement Specifications (URS) from us.
