DATA INTEGRITY
FDA DATA INTEGRITY CONSULTING, SUPPORT AND SERVICES
Experience excellence in GxP Data Integrity critical to Patient Safety & Regulatory Compliance
We 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
Isha’s GMP 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)
- 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)
Paperless validation lifecycle management systems enable the following technical controls that ensure data integrity:
- Eliminates the human errors associated during risk assessment and protocol execution
- Access control and implementation of Segregation of duties (SoD) within the workflow ensuring the right access to the right person
- Integration of organizations active directory with access rights designed for the work execution by design
- Audit trail of all transactions with history ensuring verification and management as required by 21 CFR Part 11 and Annex 11 requirements
- Centralized repository of transactions, data and records. (private SaaS cloud with enhanced security and encryption)
- Computerized workflow management to enhance review and approval with electronic signatures
- Change, deviation and risk management integrated with validation life cycle management process
- Validation protocol execution is fully controlled and captures User ID and date & time stamp at every step level to make the validation execution compliant with regulatory requirements.
- Electronic signature is enabled at the execution step level or test case level to meet the regulatory requirements.
- Evidences such as screenshots or files can be attached at the test step level with date
- Time stamp, eliminates the risk of missing the evidences or attaching the wrong evidence.
- Eliminates the possibility of missing review and approval signatures
- Eliminate the possibility of missing validation documents across the organization
- Centralized record and documentation management enabling retrieval, archival and retention methods.
- Paperless validation lifecycle management systems are an adequate solution that enable compliance with FDA and MHRA data integrity requirements.