SherpaPharma – Improves the Quality of Environmental Monitoring
SherpaPharma is an innovative software solution for managing the environmental monitoring process in pharmaceutical companies. It improves the quality of the environmental monitoring process and saves you a lot of time by generating environmental monitoring reports instantly.
SherpaPharma is a cloud-based software with a barcode code reader, offering a quick and easy implementation process. The system efficiently handles massive data imports for clean rooms, sampling points, and historical results, enabling immediate utilization. At the core of SherpaPharma is its sophisticated WiFi android barcode reader, providing full control over the timing, location, and execution of sampling procedures. The system's barcode functionality ensures meticulous traceability, with unique barcodes assigned to plates, incubators, and instruments. This feature enables precise monitoring of the entire sampling process, from the initial setup to the final results. By utilizing barcodes, SherpaPharma enhances efficiency and accuracy, offering a seamless integration of technology into the workflow of clean rooms, sampling points, and data analysis. It provides robust data analysis capabilities, allowing users to trend historical data, apply filters, and generate statistics for each point. The software ensures flexibility by adapting to various production areas, departments, clean rooms, sampling points, and even independent production plants within the same company.
Compliant with Regulations
Designed to ensure data integrity, SherpaPharma complies with FDA 21 CFR Part 11 and EU GMP Annex 11. It maintains an audit trail for all data changes, registrations, and deletions. Developed with user feedback from pharmaceutical companies, the software is continuously updated to meet evolving user needs and stay compliant with regulations. Being cloud-based, SherpaPharma offers a fully validated installation managed and secured by an ISO/IEC 27001 accredited company. The pricing is flexible, catering to installations of any size without compromising quality or data safety. The system supports unlimited user creation at no additional cost.
SherpaPharma facilitates planning by allowing users to define sampling plans using Standard Operating Procedures (SOPs) and scheduling them on a calendar. The software covers the entire lifecycle of the process, from sampling to incubation, reading, identification, review, and approval. The Audit Trail feature ensures comprehensive tracking and approval of all actions performed in the system.