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In our previous blog, Randy highlighted the trends driving management to mandate the use of ERP modules for maintenance and calibration. At the root of all of the trends is management’s need to gain a deeper perspective of the organization. In order to achieve this, corporations are looking to leverage an Enterprise Resource Planning system (ERP) to display reports and KPIs with data from across departments in the organization. This means that asset management data must also be part of the ERP system – which is the biggest driver as to why management is mandating ERP modules for maintenance and calibration.

With ERP modules for maintenance and calibration, companies may benefit from the corporate reporting perspective, however, end users are often left with unmet needs which drives down their productivity or increases investment needed to fill the gap of the unmet needs. ERP integration with a purpose-built EAM / CMMS is a balanced approach to achieving corporate demands, meeting needs of end users and providing return on investment.

Whether you use an ERP module or an EAM / CMMS application, users in the Life Sciences industry require a set of base functionality as well as GMP specific functionality. Here are a few overarching functional requirements for asset management systems:

Base Asset Management Functionality

GMP Specific Asset Management Functionality

Basic Asset Tracking

State-based Automated Workflow Engine

Work Management & Scheduling

21 CFR Part 11 Compliance

Inventory, Spare Parts Management & Kitting

Best-in-class Calibration Management

Reports & KPIs

Change Control

System Administration

Validation Tracking

As Found / As Left Measurement Data

Reverse Traceability on Standards

 

Best-in-class Measurement Data Templates

 

Best-in-class Work Plan Templates

 

Non-Conformance / Out of Tolerance Tracking

 

Audit Trail

 

On paper, an ERP module (such as SAP PM, etc.) may be able to meet the requirements noted above and may be able to meet all of the requirements in the URS (User Requirements Specification) or FRS (Functional Requirement Specifications). However, the true problem lies in how they meet the requirements. Below is a chart that highlights some of the differences between ERP modules and a purpose-built EAM / CMMS like our software, Blue Mountain RAM:

 

 Category

ERP Modules

EAM / CMMS (Blue Mountain RAM)

Base Functionality

Can Meet

Can Meet

 

GMP Specific Functionality

Can meet requirements with work-arounds and additional programming – which are often costly and time consuming

Functionality is provided out of the box and can be easily configured to meet organization-specific processes

 

User Interface

Designed for general industry use; often poorly fits GMP environments, and increases training burden and decreases technician productivity. Many implementations leverage complex lookup codes for records

Designed for GMP Environments; Purpose-built workspaces create an easy-to-use interface to manage equipment status, e-signatures, maintenance and calibration records – Increases technician productivity and decreases training burden

 

Configurability

Given the work-arounds mentioned above, configuration is challenging and often requires custom programming

Can be easily configured to match unique business processes and workflows

 

Upgrading

Work-arounds create challenges for upgrading to the latest versions of the module which increase time and cost to upgrade

 

Because of the out of the box functionality, upgrades can be completed quickly and with streamlined validation

Adaptability

Because of work-arounds, changes in business processes are challenging to implement; many companies stick to processes determined during initial implementation which prevents interval improvements in their maintenance and calibration programs

Out of the box functionality allows companies to easily adapt processes over time and streamlines validation/change control. Organizations can frequently revisit and adjust business processes to make improvements to compliance and/or productivity

 

Validation

Third parties will provide validation, often costly and time consuming

Validation is streamlined because of vendor knowledge in Life Sciences industry and track record of previous validations

 

Cost

Costly to initially implement, build in work-arounds which require custom programming, validate and maintain over time. Because of added work-arounds and cost to implement and maintain, there is reduced return on investment

 

Provides significant ROI for an organization because the system is packaged with functionality that drives productivity, while providing necessary tools to manage compliance including customizable workflows with e-signature capability – for more information on ROI, read this blog

 

Overall corporate goal to obtain a single reporting source across organization

 

Because it’s modular, reporting happens seamlessly within ERP system

By integrating with an ERP system, reporting can happen seamlessly.

 

Despite the fact that ERP modules can meet user requirements on paper, the key is how they meet the requirements. If you are mandated to use an ERP module for maintenance and calibration, we encourage you to see how each of the requirements are met as compared to a purpose-built EAM / CMMS software such as Blue Mountain RAM. Integration with an EAM / CMMS is a viable alternative to using ERP modules that can benefit both management (because of reporting capabilities and improved ROI) and end users (because of how requirements are met).

In the next blog in our Battling the Mandate series, we’ll cover an overview of integration and some popular integration scenarios.

 

Read more of our Battling the Mandate blog series:

  1. Successful Solutions for ERP/EAM Interaction
  2. ERP Module v. EAM/CMMS
  3. ERP / EAM Integration Styles
  4. Pitching Integration to Management