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Maintenance In The Life Sciences: Trends, Regulatory Hurdles & Benefits

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By: Peter Mantas

The recent growth in the biotech industry has provided emerging and mature life sciences companies with the opportunity to increase capital expenditures, enhance R&D spending and pursue joint ventures and acquisitions. This increase in capital spending in addition to the immense regulations within biotech means CMMS, ERP and SaaS programs are becoming increasingly important for companies to manage the costs and development of new drugs. For life science companies, one of the major advantages in using a CMMS solution is the ability to limit major unplanned maintenance events that may occur during the research phase. CMMS software is an excellent tool to help maximise equipment availability while keeping maintenance costs under control. In a recent survey, fifty-eight percent of professionals that do not use CMMS software reported they often have difficulty managing recurring maintenance events. In contrast, approximately 20 percent of CMMS, EAM/ERP and custom software users reported never encountering this challenge.

Biotech CMMS

Particularly for emerging and mid-sized life sciences manufacturers, the SaaS approach offers an important opportunity to explore the large cap venture regime. Over the last few years, CMMS asset management, SaaS and ERP delivery for these industries has grown in popularity due to their rapid deployments and cost benefits, specifically for companies with limited resources and aggressive product timetables. For major life science and biotech companies, successful implementation of CMMS software is crucial to providing the needed ROI in order to speed up the patent process given the large upfront costs involved. According to Life Sciences Leader magazine, a recent study conducted by Reliabilityweb.com, CMMScity.com, and Maintenancebenchmarking.com demonstrated that even unregulated industries struggle with this selection and implementation, with 57% of the respondents indicating that their CMMS or EAM implementations failed to meet their ROI expectations. Therefore, selecting a CMMS that delivers on the total cost of ownership is critical. We believe we have the ideal solution as it is web hosted, simple to use and includes inline training videos on each screen.

This type of risk is not conducive to the high cost research environment seen in biotech, especially given the immense regulatory hurdles (by the FDA or other international agencies) the industry as a whole faces. However, despite the barriers in fully adopting this software, it seems that the high regulatory benchmarks are actually a blessing in disguise:  greater cost controls in production and regulatory requirements place more emphasis on control of processes, and the CMMS solution provides significant advantages in this area.

Some of the major regulations that life science companies face when choosing a CMMS solution include the following:

  1. ISO (International Organization for Standardization): ISO 9001 for the operation and maintenance of critical assets.
  2. 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. New CMMS providers must be able to assist customers comply with FDA requirements by offering such features as enhanced audit trail and electronic signatures.

Growing and established life science organizations that use a low cost CMMS solution see significant advantages:

  1. Shortened time of drug product development cycles through better maintenance scheduling. This increases the efficiency and effectiveness of properly maintained scientific equipment;
  2. Better work order assignment and request management, reducing the costs of downtime;
  3. Greater access to historical reports, reducing the cost of compliance;
  4. Reduced maintenance expenses. Expensive, complex machinery receives preventive and reactive maintenance.

Finally, one of the major benefits for a CMMS or ERP application is the ability to further leverage the implementation from the first site to global sites. Mobile solutions will be increasingly important, especially since scaling the solution to similar operations, business units and processes will assist in compliance with international regulators. A properly implemented proactive and cost effective CMMS system with custom settings provides for the ideal solution for any life science or biotech operation.

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About Peter Mantas – Peter Mantas offers legal and strategic support to the Industry Research team. He has previous experience in the corporate group of a large Canadian law firm and as a research associate for a major Canadian financial intermediary. Peter holds a B.Com from the University of Ottawa and an LL.B and B.C.L. from McGill University.

Disclaimer – None of the information above is legal advice and it should not be taken as such.

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