GxP-regulated companies in life sciences and food and agriculture have specific requirements for data integrity, storage, and compliance. They employ various data logging and storage methods, ranging from handwritten and signed paper traces to single-computer data storage systems to multi-server data centers.
However, these cumbersome methods can quickly lead to errors, workflow non-compliance, security breaches, and even data loss in case of computer or server failures. These issues can compromise patient safety and impact the company’s regulatory status.
1. Maintains Compliance
ATEK has developed various monitoring solutions that not only allow data storage on a company’s physical server but also store it in the GxP-compliant cloud according to regulations (our cloud service, ATEK Platform).
This platform meets regulator requirements by ensuring the integrity, reproducibility, and traceability of data used throughout the manufacturing, storage, and shipping process of clinical or commercial products.
2. Reduced Operational Costs
Companies regulated in the pharmaceutical, biotechnology, vaccine, medical device, food, and other sectors should seriously consider adopting or updating ATEK monitoring with cloud storage for various reasons.
Indeed, storing data on the ATEK platform allows replacement of initial costs and resources such as planning, purchasing, installing servers, and manual system validation.
Furthermore, physical data is only available and accessible on the company’s network. Through the ATEK platform, users can log in with unique credentials to access data from anywhere in the world using simply a web browser on their smartphone or tablet.
3. Scalability and Continuity
Due to its unlimited growth capacity, companies can expand their data storage capacity as their business needs evolve, consolidating research and development, production, and storage data.
The benefits of cloud data storage for temperature monitoring are numerous. A perfect example is when companies conducting clinical trials ship their temperature-sensitive products worldwide.
Instead of waiting for the clinical trial site or end user to upload the data, email files, or send the device by physical mail, quality, regulatory, and clinical trial managers can now instantly view data and receive alerts from their workstations or personal smartphones.
This allows them to determine whether a temperature excursion has occurred and whether the medication is safe to administer to the patient. In this type of situation, real-time access to data becomes essential.
Through our cloud-enabled devices, such as our reusable temperature data logger, customers can make data-driven decisions and potentially save thousands of dollars in case of product loss while maintaining regulatory and GxP standards.
