Maximo can help life science companies meet this new environment by:
- Ensuring that assets are properly maintained and calibrated - essential to meeting organizational production objectives and governmental regulations.
- Getting a comprehensive overview of critical assets and their status.
- Predicting and preventing asset related problems before they become conformance issues and managing corrective and preventive actions (CAPAs).
R.O.I.
Projetech's Maximo as a Service provides significant financial benefits for life science companies:
- ROA (Return on Assets) is increased because expensive, complex machinery receives preventive and proactive maintenance.
- Time to revenue (shortened times of drug product development cycles) can be reduced, due to higher effectiveness of properly maintained equipment.
- Cost of risk (such as downtime) is reduced because of the higher availability of critical equipment.
- Cost of compliance efforts are reduced.
Regulations
Projetech's Maximo as a Service addresses life sciences asset management regulations:
- CAPA (Corrective and Preventive Action): Prove that asset corrective action had been completed.
- ISO (International Organization for Standardization): ISO 9001 can mandate the operation and maintenance of critical assets.
- FDA (Food and Drug Administration): FDA 21 CFR Part 11: Requires drug makers to implement controls, such as audits for all systems involved in processing electronic data that are used to demonstrate compliance.
