Data Integrity and Software Implementation
Reliable Data Integrity & GxP Software Implementation
Data Integrity & Software Implementation
Enabling Trustworthy Systems and Compliant Digital Transformation
In today’s data-driven life sciences landscape, ensuring the accuracy, reliability, and compliance of data is non-negotiable. At Bionetwork Consulting, we help pharmaceutical, biotech, and medical device companies implement software systems and data governance practices that protect data integrity across every stage of product development.
From selecting the right digital tools to validating systems in accordance with GxP and 21 CFR Part 11, our experts ensure your data is secure, traceable, audit-ready, and fully aligned with regulatory expectations.
Streamlining Compliance with Expert Software Solutions
Our Services Include:
Data Integrity Assessments
Gap analyses and remediation planning based on ALCOA+ principles to evaluate your current state and ensure compliance with global data integrity requirements.
GxP Software Implementation
Support in selecting, configuring, and validating GxP-compliant software systems (e.g., LIMS, eTMF, QMS, EDC, CTMS, ERP, MES).
System Validation & 21 CFR Part 11 Compliance
Full lifecycle validation including URS development, risk assessments, IQ/OQ/PQ execution, and documentation in line with FDA, EMA, and MHRA expectations.
Vendor Evaluation & Implementation Oversight
Guidance on selecting qualified vendors and overseeing system deployment to ensure technical alignment and quality compliance.
