Data Integrity Solutions in Pharma
Assurance on accuracy, consistency, safety of laboratory data within GMP environment over its entire life-cycle, including review critical aspect to the design, implementation and usage of any system which stores, processes or retrieves data on following parameters as per regulatory requirements:
- Attributes
- Legibility
- Originality
- Contemporaneous documentation
- Availability
- Endurance
Our Services
- Comprehensive Engineering Solutions
- GXP Audits and Expertise
- Establishment and Implementation of Quality Management Systems
- GAP Analysis With Respect To All International Regulatory Requirements
- Qualification and Validation of Facilities, Equipment’s And Utilities
- Dossier Preparation and Submission
- Triggering Of Any International Regulatory Audits
- Training and Development
- Data Integrity Solutions in Pharma
- Panel Advice For US FDA-483