|
The Pharmaceutical Industry – one of the most highly regulated of all industries – has set quality standards and stringent requirements
for how records are stored and maintained in electronic archives. To ensure product integrity and quality, it is essential to have
consistent records of:
- Operations and procedures
- Process settings and variables
- Production events and conditions
- Quality and performance attributes of raw and in-process materials
Electronic batch records (EBRs) are a way of compiling production data into a common document,
unique for each batch produced. It is extremely important to understand what constitutes
a compliant electronic batch record system. Also, it raises considerable questions:
What level of electronic data capture is required? How is this data captured? How is it
retrieved, analyzed, and reported? How is the integrity of data ensured? While these questions
sound simple, their not-so-trivial answers are critical to having the right solution in place.
TrakSYS™ real-time decision support for manufacturing execution is designed to help manage operational
complexities and improve quality and productivity. In regulated industries such as pharmaceutical and
food, electronic batch records represent a significant opportunity for improvement. TrakSYS effectively
paves the road for delivering compliant, paperless EBRs.
 Sample EBR
For more information download "Effective Management of Electronic Batch Records" with TrakSYS™.
| 
.jpg)
