Lachman Consultant Services, Inc.
FDA DATA INTEGRITY CONSULTING, SUPPORT AND SERVICES
Experience excellence in GxP Data Integrity critical to Patient Safety & Regulatory Compliance.
Make Lachman Consultants’ Data Integrity Services an essential part of your organization’s operations.
Working closely with your company and cooperatively with Lachman Consultants’ other practice groups, our team of dedicated pharmaceutical industry and life sciences experts efficiently and effectively ensure that your data is complete, accurate, trustworthy, and reliable.
All Lachman Consultants’ Data Integrity services incorporate the highest levels of quality and risk management systems, including adherence to sound scientific principles and good documentation practices.
For 40+ years, our FDA data integrity consultants have been helping companies like yours ensure patient safety while helping protect your organization from enforcement actions.
Lachman Consultants Performs High Quality Data Integrity Risk Assessments for the Pharmaceutical Industry including:
- Qualifying instrumentation
- Validating software applications as configured
- Verification of custom fields and calculations
- Data gathering, processing, and security
- Data and records security auditing and accountability
Lachman Consultants’ Approach to Data Integrity:
- Generating Data Flow Diagrams for each system, and identifying areas within the operations that affect the integrity of data (e.g., Auditing)
- Evaluating “ALCOA+” risk at each stage (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring and Available)
- Identifying Risks-to-Data-Integrity to be mitigated
- Providing interim CAPA as required
- Periodically re-assessing data sets and configurations
Please contact us below for immediate assistance. Our experts are available to answer any questions and provide further details on the data integrity services we can provide to support your business: