Pharmaceutical

1. Advanced Management of Recipes and Formulations
Sky MES features an advanced system that allows for the creation and dynamic adaptation of complex formulations, ensuring agile adaptability to market demand changes and regulatory specifications.

2. Integration with Pharmaceutical Devices
Sky MES stands out for its adaptability and compatibility with various market protocols. The platform ensures seamless integration with pharmaceutical production devices, allowing precise control over every operation and efficient bidirectional communication. Moreover, it enables centralized recipe management and the dispatch of parameters to specific devices, ensuring operational consistency and secure transmission of instructions.

3. Real-Time Control of Critical Parameters
The platform constantly monitors processing parameters, allowing immediate response to process deviations and eliminating the risk of non-conforming products.

4. Traceability with Unique Identification
Sky MES implements advanced traceability systems, such as barcodes and RFID, ensuring the unique identification of each component and swift identification of potential issues related to raw materials or equipment involved in processing.

5. Laboratory Quality Control and Calibration Management
The solution integrates and oversees laboratory quality control processes in real time, automatically recording test results for an instantaneous view of quality in every batch. Moreover, SkyMes includes calibration management to ensure the accuracy and compliance of instruments.

6. Rigorous Process Validation
Fully compatible with Good Manufacturing Practices (GMP), Sky MES enables rigorous process validation with detailed documentation, ensuring compliance with regulatory standards.

7. Regulatory Framework Automation
The management and automation of procedures dictated by international regulations, particularly European (EMA) and United States (FDA) regulations, are an absolute priority for SkyMes. SkyMes ensures detailed and efficient management of all documentation relating to production processes, facilitating the generation of records and reports necessary for regulatory authorities and guaranteeing full traceability and transparency of procedures.

8. Predictive Analysis and Continuous Improvement
Sky MES uses predictive analytics to anticipate potential problems and optimize production processes, promoting continuous improvement based on data.

9. Advanced Security and Data Traceability
We implement advanced security measures to protect the integrity of data and operations, recording every action through computerized procedures with traceable and secure access in full compliance with regulatory requirements.

10. Precise Control of Sterilization
Sky MES enables precise control of sterilization, from devices to autoclave processes, rigorously documenting each step to ensure compliance with regulatory standards.

11. Implementation and Monitoring of Cleanroom Production
SkyMes ensures proper management of cleanrooms, guaranteeing a controlled environment for critical activities and avoiding any risk of contamination.

12. EU and US Regulatory Monitoring
Sky MES ensures monitoring and compliance with European (GMP) and North American (CFR 21) pharmaceutical regulations, ensuring conformity to the legal requirements established by the two markets. Moreover, the management and generation of digital documentation necessary for audits guarantee full compliance with all regulations.

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