Why is Change Management and Version Control so important in a highly regulated environment like PHARMA?
Programmable logic controllers (PLC) are the backbone of automated manufacturing in the pharmaceutical, biotech and medical device industries: With the AutoSave platform, MDT has a history as the world leader in automation change management, supporting the most comprehensive range of PLCs, devices and editors.
These devices PLCs are programmable and are based on digital programs (software) that define its functionality and functioning. Programs are stored electronically in the device and on electronic backup media.
For this reason they are considered electronic records and meet the requirements of 21 CFR Part 11.
Conventional record monitoring and change control methods would not suffice for records associated with programmable devices.
It is not uncommon to find that i PLCs are sourced from a variety of manufacturers where each brand comes with a unique set of development tools program and device management.
Add to this the many legacy systems installed in an operating plant and one begins to understand the vastness of the problem of change control and program archiving: program files represent the result of hundreds of hours of work. If a device fails or a program is lost, not being able to roll back to the last known working version can result in significant financial loss. in the form of production downtimes.
An autosave server MDT AutoSave memorizes all the programs in order to have access (and therefore restart more quickly) during crisis situations. The server is solely responsible for system security and privilege checking, archiving versions and ancestors, managing program files, and creating Audit Trails for historical tracking.
For each PLC connected to the network, the MDT AutoSave Server logs:
- The type of device
- Where is the device on the network
- The type of software used to program the device
- Who is authorized to access that device and the changes they are authorized to make.
- Previous copies or ancestors of production copies. Multiple previous versions can be archived.
- Master copies or named versions of programs
Basically…all electronic files and program copies associated with programmable devices reside in one location, the MDT Autosave Autosave server. Backup is controlled and automatic so you take the guesswork out of manual backups.
