GxP Regulation
The gap between the potential offered by AI and the current paper-based or data-challenged reality in laboratories. The gap represents a critical challenge for companies needing to comply with complex GxP regulations, while also striving to modernize and optimize their operations.
Welcome to a new frontier in precision and integration, where meticulous attention to engineering details meets the rigorous demands of GxP standards. Here, we challenge the status quo of data management in scientific and medical fields by offering a solution that not only adheres to the highest standards of product development and compliance but also exceeds them, ensuring unparalleled quality control and validation.
We are redefining seamless integration. Our approach brings together data from Electronic Batch Records (EBRs), various laboratory instruments, and clinical studies (eTMF), transforming complex datasets into actionable insights. This capability ensures that data flows smoothly and efficiently across different stages of development and testing, bridging gaps and enhancing connectivity.
Traceability and Auditablity
CIPHERS provides detailed logs and reports of all file movements, ensuring that Life Science companies can easily track and verify the integrity of their data. This is essential for GMP, GAMP, GLP, and GCP regulations, which require strict control and documentation of data.
Data Integrity
CIPHERS ensures data integrity by verifying the integrity of files during transfer and at the destination, preventing any unauthorized modifications or deletions. This is critical for GMP, GAMP, GLP, and GCP regulations, which require data to be accurate, complete, and consistent.
Validation Qualification
CIPHERS can be validated and qualified according to GAMP regulations, ensuring that it meets the necessary standards for use in Life Science companies. This is important for GMP, GLP, and GCP regulations, which require the use of validated systems.
Change Management
CIPHERS provides a centralized platform for managing and monitoring data movements, enabling Life Science companies to manage changes to data and systems in a controlled and auditable manner. This is essential for GMP, GAMP, GLP, and GCP regulations, which require strict control over changes to data and systems
How to control your data
CIPHERS
By implementing CIPHERS software, Life Science companies can ensure compliance with regulations such as GMP, GAMP, GLP, and GCP while also enhancing their data integrity and traceability. Our software provides a robust and secure platform for managing data movements, ensuring that Life Science companies can maintain the integrity and security of their data while also meeting the regulatory requirements of GMP, GAMP, GLP, and GCP
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