Improved Data Integrity via Digitization of Environmental Monitoring
Complimentary
Learning Level: Intermediate
Time: 1000 - 1100 EST
Session Length: 1 hour
In today’s pharmaceutical industry there is myriad of GMP data being generated in the field of environmental monitoring. This is a challenge, knowing the increasing demands to perform further additional testing. The new EU annex 1 further increases the requirement for improved data integrity to ensure that facilities are maintained in a state of GMP compliance. Data integrity is not restricted to electronic records and electronic signatures (as described in CFR 21 Part 11); it should be considered as a holistic and consistent approach, taking into account the role of people, processes, and technologies. In this webinar we will explore the data integrity principles and discuss how the automation and digitalization of the Environmental Monitoring (EM) process allows a facility to:
- have better control of manufacturing
- secure product safety, mainly related to pharmacovigilance,
- eliminate low value, manual, error-prone tasks
- Increase the confidence of regulatory agencies in facility’s quality systems by strengthening the approach to data integrity
Learning Objectives
- Deployment of digital solutions will help to ensure compliance with Data Integrity principles.
- Deployment of digital solutions will enhance companies facilitate the decision-making process at every level of the organization.
- Deployment of digital solutions will improve resources optimization and dismiss risk of error during Quality Control process.
