Quote from EMA Guidance on good manufacturing practice and good distribution practice
Data integrity enables good decision-making by pharmaceutical manufacturers and regulatory authorities. It is a fundamental requirement of the pharmaceutical quality system described in EU GMP chapter 1, applying equally to manual (paper) and electronic systems.
Furthermore FDA has provided a Guidance for Industry the emphasize the importance of Data Integrity – Link.
Pharma IT is experienced within data integrity and can support you on your journey to to establish a sound data integrity practice in the company. Pharma IT work according to the ALCOA+ principles and we have experience from a number of data integrity projects in various formats:
- Data Integrity Awareness
- Data Integrity Training
- Data Integrity Policy and SOPs
- Specific mapping of processes and systems in respect to ensuring data integrity
- etc.
If you need support don’t hesitate to contact us.
