Greetings in the New Year. This time of year, it’s hard not to make some predictions. There are certainly trends that will shape our lives in GMP asset management and our professional lives.
Here are the key trends I see continuing or gaining speed in 2012:
- Higher GMP Enforcement – it’s hard to think that GMP enforcement could get any tougher, but I believe it will. The FDA will continue with strong enforcement including High Impact Warning Letters, 483’s and Consent Decrees. In 2011, there were several high visibility enforcement actions, including one that listed missed Preventive Maintenance activities for the plant’s closing. Now that hits home, especially when the plant closing creates a shortage of the cancer drug it makes. Look for more enforcement activity in area of production equipment maintenance, as the FDA applies what they learned in the coming year.
- Investment in Higher ROI Applications – Many Pharmaceutical, Biotech and Medical device firms did well in 2011 and that means they will be looking to invest in projects with fast Return On Investment (ROI). To meet the needs of higher productivity and increased GMP compliance, companies will invest in automation solutions that can provide these benefits. Competition for project funding is always strong, but with manufacturing capacity, Overall Equipment Effective (OEE) and other key metrics being watched by senior management, asset management solutions are at the forefront of funding.
- Increased Use of Paperless CMMS Technology – This is a trend that gained momentum last year and will most certainly continue in the New Year. Driven by Wireless and Work Flow tools, companies will step up their reliance on CMMS/EAM to achieve the higher productivity provided by reducing wasted steps, automating work flow and utilizing Part 11 electronic signatures to their fullest. The easiest gains will be made by companies reconfiguring their current systems in an incremental fashion to move toward a “paperless” environment.
- Turning Data into Useful Information – In 2012 more companies will take advantage of the years of data being collected in their CMMS/EAM systems. Investment in learning the basics of how to query and develop reports will provide the biggest gains in this area. By using Data Mining & Business Intelligence tools companies will take advantage of existing applications to drive even more value. The ability to generate useful information in the form of Dashboards, Key Performance Indicators and more graphic reports will be more prevalent.
- Rapid Acceptance of Virtualization and Cloud Based Services – There has been rapid adoption of using server virtualization to drive down the costs of robust GMP system architectures. The ability to host web based CMMS applications almost anywhere is upon us. Whether these are internal systems or 3rd party “Cloud” services, they are changing the way applications are being deployed. In a GMP environment where there are typically development, validation and production instances the costs can be minimized by using virtualization. On the small implementation end of the scale, many companies are using third party cloud based environments to run their critical systems, including maintenance and calibration applications.
What do you think the top trends of 2012 will be?