Regulatory & Compliance Management with HYDRA X for Process

The ongoing digitalization in regulated life science industries, such as the pharmaceutical industry and medical technology, needs secure, traceable, and compliant electronic systems, with 21 CFR Part 11 serving as the central regulatory framework for electronic records and signatures.

Regulatory & Compliance Management in HYDRA X for Process integrates all key functions supporting regulatory compliance and the structured control of manufacturing processes. It includes digital manufacturing specifications, documentation, and traceability, ensures data integrity according to the ALCOA+ principle (Attributable, Legible, Contemporaneous, Original, Accurate), and provides quality approvals, risk and change management (e.g., in accordance with ISO 14971), as well as validation and training certificates. 

With audit trails, electronic signatures, and reporting tools, HYDRA X for Process helps manufacturing companies to reliably meet regulatory requirements while ensuring process transparency and continuous compliance with FDA 21 CFR Part 11, EU GMP (including Annex 11), and ISO 13485.

• Master Batch Record (MBR) – Approved, version-controlled manufacturing specification for a standardized and reproducible production of batches.
• Electronic Batch Record (EBR) – Digital, audit-proof documentation of batches for the structured, system-supported, and GMP-compliant manufacturing and documentation of a batch.
• Batch Record Review (BRR) – Formalized, documented quality control process for the GMP-compliant check of batch documentation verifying completeness, accuracy, and deviations and documenting approval activities.
• Review by Exception (RBE) – Risk-based, automated quality control method to efficiently and effectively approve batches based on predefined rules, limit values, and deviation criteria.
• Compliance – System supporting regulatory compliance through role-based controls, unique user identities, and GMP-compliant signature processes.
• Audit Trail – Audit-proof, transparent logging of changes for GMP-critical master data and system events.

• Regulatory compliance out of the box
• Standardized manufacturing processes minimizing errors
• Significant efficiency gains in batch documentation and verification
• Enhanced product and process quality through consistent transparency
• Handling of deviations with integrated quality and CAPA processes
• Improved audit and inspection capability
• Reduced compliance risk through automated validation steps
• Traceability and data integrity throughout the entire manufacturing process