How are Regulations Re-shaping PLM?September 26, 2015
Regulations are the necessary devil the organizations need today. Federal Regulations such as SOX, FDA Regulations etc. make sure that the organizations deliver the best to their consumers. Since the PLM is at the core of most of these organizations a proper and complaint PLM implementation is necessary to ensure compliance.
Most of PLM systems today demand more than just process compliance. It should have –
- Proper reporting mechanism.
- Proper Change Control to track and record even minor changes.
- Capability to generate Audit Trails.
- Well defined boundaries in terms of roles and responsibilities.
- Dynamic integration with government regulators to submit and receive real time information.
PLM “expert systems” today are capable of achieving the above requirements and more. However the problem is not generally on the application side. The changes required to be compliant are often costly. The cost of PLM implementation which is high enough and it surges even higher with the new regulatory change – new complaint machines, labor training for new policies, process inductions for executives, inventory process changes, selection of compliant suppliers etc.
The PLM experts are challenged today to make PLM processes flexible. The PLM process should be capable enough to accommodate minor revisions of regulations and hence save the both time and money.