Life Science/ Pharmaceuticals

The life science industry is undergoing significant trends. Companies must shorten time to market to gain maximum revenue from proprietary drugs, which is difficult in the face of increasingly global and outsourced environments. They must reduce costs to stay competitive, while maintaining high product quality to comply with strict regulations. 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 time 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.
• Costs 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 has 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.