Working with Maximo Asset Management in a Validated and Compliant State
Mary Gorczynski 1100006B54 email@example.com | | Tags:  validated with maximo working management state a and compliant in asset
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Today's blog comes from Eric Luyer.
Managing a critical information system like Maximo in typical regulated industry,such as life sciences/pharma and food & beverage, is not an easy task. Every change – major and minor – must be evaluated for product risk and validated to comply with stringent regulations from governmental bodies such as the US FDA (US Food and Drug Administration) and their counterpart regulatory bodies all over the world.
We, at IBM are always working with our customers to take advantage of new functionalities available in the latest releases of new software versions, but customers in these regulated industries often have to wait for a long time in order to justify the efforts associated with implementing and validating a new software version. This exercise requires a significant investment in resources, time and money simply to upgrade to the latest software version.
However, both the “regulators” and companies in regulated industries are slowly rethinking their approach to compliance and validation. We see now a shift to embrace a so-called “risk-based” approach to validation and compliance.
Using this approach, companies can analyze a functional system and determine the risk levels of individual functions so that testing can be appropriately scaled to risk. This approach differs with the traditional approach where every piece of functionality is tested with the same rigor, regardless of level of risk.
In the age of limited resources, FDA is now supporting and encouraging the implementation of a risk-based approach to validate a computerized information system. This approach would provide benefits from increased productivity, reduction validation cost and lead time of the whole process, while managing the risk upfront.
The implementation of this new thinking is in practice a slow process. It takes time to evaluate the impact and to gain valuable input from organizations or customers in these industries to incorporate this new approach and take possible actions to take advantage and still stay compliant!
IBM has taken specific steps to support the regulated industry in implementing these new risk based initiatives. For the last 2-3 years IBM has developed a new program building on the strong relationships with customers using the IBM software in regulated environments.
To build upon our partnerships with (key) customers in this industry, IBM has launched the Maximo Quality Partner Program (QPP). The primary purpose of the QPP is to reduce the resources and time associated with validation efforts by implementing a collaborative testing, verification and validation strategy. This program makes it possible for customers to get valuable insight and documentation of IBM’s quality processes to support this Risk-Based initiative.
Key customers involved in the program include Abbott, Eli Lilly and Covidien, as well as a Business Partner Strategic Maintenance Solutions (with valuable expertise in validation projects with Maximo) and Life-Science Industry Analyst firm Axendia, who all are actively participating and have already provided valuable input to the IBM Software Quality Assurance team.
The positive outcomes of this Quality Program for our customers in regulated industries are:
Results of this initiative were recently presented in Life Sciences Maximo User Group meetings and will finally be included in the “Maximo Risk Based Validation package” as new content in the Compliance Assistance Documentation package that is available as part of the industry solution for Maximo for Life Sciences.
Let me know if you have specific questions on this topic and I’ll recommend you to read the newly updated whitepaper on validation and compliance in regulated industries: link
Thanks for reading and please look out to my next blog, which will be focused around activities planned for next year, varying from the Pulse Conference in March 2013 to User Group meetings for Manufacturing and Life Sciences and possibly a next User Event for Healthcare/Hospitals.