Bioprocess data is gathered in multiple instances throughout process development and manufacturing stages. An integrated facility strategy for data collection and storage can provide multiple benefits, including an enhanced security, facilitated data reporting, increased reliability, increased up-time, and overall quality improvements.
Specific examples include the following:
- A centralized integrated IT infrastructure streamlines user account maintenance and simplifies user access. Computer policy settings are easily administered to the technical staff and the same account credentials are used on all equipment.
- When cGMP data is stored and accessible from a central location, report creation, data trending and evaluation of batch run data is easier compared with if data is stored in multiple locations. An integrated automation solution will also improve process alarm management through remote monitoring, SMS text message notifications and a single workstation view of the entire factory.
- Redundancy can be applied to critical components to ensure uninterrupted operation in the event of a hardware failure, for example, a failure in an interface terminal. Workstations are interchangeable for additional flexibility.
It is critical to design and plan for automation integration early in the facility design phase. The integration details for all equipment should be thoroughly specified to avoid redesign later, sufficient time should be allocated for equipment installation and wiring between buildings and rooms, and extra time should be planned for change control. It is also helpful to carefully plan integration activities in discrete elements that can be achieved during limited facility downtime.
In a globally competitive marketplace, tangible benefits of a fully integrated automation solution are no longer a nice to have – but a business requirement.