Electronic Production Records Utilising Technology to Enable Innovation in Life Sciences
With the growth of computerized systems and automation being used throughout the healthcare manufacturing process, Manufacturing Executions System (MES) Technology has been introduced to the work Process.
The technology has spawned the use of electronic record creation of the production record entries.
"Desired State" - goal as described in FDA risk-based approach guidance.
Timely e-records production and access mitigate the risk.
Continuous "real time" Quality Assurance (24x7).
(CPP) Critical Process Parameter data recorded and correlated to product quality characteristics - how process factors impact performance or product.
Tools such as statistical process control and ad-hoc reporting to facilitate better scientific process understanding and provide the basis for PAT (Process Analytical Tec
- Paul Irving Principal Consultant - Northern Life Sciences Ltd