In the recent past, few of our prospective pharma manufacturing clients inquired about the need to go for a dedicated Enterprise Asset Management (EAM) system while maintenance management functions are already available in their existing ERP. I advised them not to make a decision based on the feature list alone but also based on the depth of functionalities & regulatory (FDA) compliance requirements of the proposed system for their Engineering functions.
As a practitioner who worked both in IBM Maximo and SAP PM, I would like to provide the top 10 advantages of using a dedicated EAM solution such as Maximo Life Sciences in an SAP environment
- Monitoring & Control of Pharma Engineering processes: Maximo is a purpose-built Enterprise Asset Management (or CMMS) application with a focus on Asset related business processes. It helps in monitoring & control of Engineering processes related to maintenance & calibration, unlike SAP which is focused on gathering data on the financial stand-point.
- Designed for Life Sciences: Maximo provides the following Life Sciences specific asset management features: a) Calibration of Instruments, Equipment & Standards b) 21 CFR Part 11 compliance related to e-records and e-signatures c) Equipment/ Area Validation d) Provides support for CSV and Quality validation requirements e) Follows GMP based implementation process
- Meets CSV requirements: As per GAMP5, Maximo can be classified as Category-4: Configured Product and all of the requirements can be met without any customization. This will help to meet the Computer System Validation (CSV) requirements easily. In the case of SAP, the validation needs to be done for the entire application, which could be a daunting task.
- Meets on-going qualification requirements: Maximo’s numerous built-in tools support controlled, incremental deployments for any process changes required and helps in IQ, OQ & PQ validation process required for Life Sciences Organizations.
- Meets approval process requirements of Pharma: Maximo contains a very powerful set of tools to make implementation and deployment process fast and stable. The workflow designer & role-based security features of Maximo can help to meet pharma specific QA & Engineering approval processes from Asset induction to retirement.
- Depth of functionalities required for Pharma: While both SAP and Maximo support all basic maintenance functionalities, Maximo supports advanced maintenance practices that are crucial for capital-intensive pharma manufacturing organizations. Maximo is designed to enhance Reliability Centred Maintenance (RCM), predictive maintenance, and financially optimized maintenance processes.
- Mobile app built for Pharma: The implementation of a user-friendly Mobile application for the EAM system will significantly improve system adoption, increase wrench time and eliminate double entry of data i.e the need to enter the engineering & calibration readings in a paper and then update in the system. Unlike SAP, IBM marketplace provides 3rd party Native Mobile applications such as EAM360 mobile app built specifically for Engineering & Calibration activities of Pharmaceutical organizations.
- Freedom to grow even in a regulated environment: Maximo can be upgraded to future versions at any time with the support of compliance assistance documents, independent of SAP. Upgrades to SAP might be difficult due to dependency on the company-wide SAP upgrade strategy. Also, upgrades will take a huge time in comparison with Maximo.
- Ease of Use: Unlike SAP, Maximo’s user interfaces are configured/modified role wise during implementation. It helps in quick adaptability of the system and improved usage. SAP users must accommodate the software, rather than the software accommodating needs of the business. The usage of SAP implementation in pharma is limited to a data entry system from the existing paper forms.
- Easy to Integrate with Pharma IT systems: Maximo EAM provides a robust integration framework for integrating any application and collecting data from sensors. This makes it easy to integrate with several stand-alone systems in pharma companies such as MES, QMS, VLMS and Time & Attendance Solutions. Also, Maximo can be interfaced with SAP quite easily using a ready-made SAP adaptor.
Author:
Arul Varadarajan
Principal Consultant & Managing Partner - Enterprise Asset Management
