In pharmaceutical industries, asset management is a core requirement that helps an organization cut costs, increase productivity, and reduce wasted time through efficient and effective maintenance and planning. A critical aspect of asset management in pharma and biotech is the traceability and the recording of asset maintenance activities for regulatory purposes.
During routine Food and Drug Administration (FDA) audits, companies must be able to show the traceability of raw materials and inventory, but they also must demonstrate the traceability of process equipment. This includes associated calibrations, preventive maintenance, and corrective maintenance activities (e.g., breakdowns) records. Pharmaceutical companies must document each step of the change control process required for asset maintenance.
The standard Microsoft D365 Asset Management module is a flexible tool for companies that want to exploit enterprise resource planning (ERP) solutions to manage their assets and resource maintenance. In order to provide pharmaceutical companies with efficient, business-oriented, industry-specific features, AX for Pharma developed the AXP365 EAM™ module. AXP365 EAM™ is a suite of functionalities developed ad-hoc to meet pharmaceutical customer needs in asset management processes—helping them to meet regulatory requirements.
The AXP365 EAM™ module provides pharmaceutical customers with unique features such as:
Learn more about these features.
Work orders represent the core of maintenance management. Each work order collects information about equipment, worker, spare parts, time, and costs allocated to a maintenance operation. Therefore, work order management must be highly controlled and documented in every business that wants to increase productivity and efficiency.
The work order approval workflow, a specific AXP365 EAM™ module feature, empowers the traceability processes in the asset management module—reducing human errors and increasing efficiency. The approval workflow is a flexible tool that can be configured to document and control the maintenance department operations during daily activities.
With the work order approval workflow, department managers and other company key roles (e.g., high-level management) can approve work orders—increasing control over the resources, materials, and costs allocated to the work order. The feature is flexible and can support multiple approval scenarios, including but not limited to:
The work order approval workflow can be used to direct approval to different users or departments depending on conditions and potentially with multiple approval steps. The user who is assigned to the approval step can either:
The system maintains a full audit trail of performed activities as part of the workflow, including who performed the action and when, thus fully complying with regulatory requirements.
AXP365 EAM™ module also enables you to electronically sign work order updates. The electronic signature is fully compliant with FDA guidelines for audit and regulatory purposes in biopharma industries (21 CFR Part 11).
Applying an electronic signature allows for the complete traceability and recording of your asset maintenance process. It keeps track of the work orders’ status and collects information about who updated it, when the change was performed, and why. You can freely define which maintenance steps should be secured with an electronic signature to support your specific company’s processes.
Combining the AXP365 EAM™ work order approval workflow and the AXP365 EAM™ electronic signature is easy and dramatically increases pharma businesses’ compliance with regulatory authorities.
The capability to define a classification of the company’s equipment is one of the essential requirements for maintenance and risk-based asset management. Correct classification of assets based on the impact the equipment will have on the company’s safety and production processes is a strategic activity that minimizes wasted time and allows for accurate planning and a reasonable allocation of resources.
With AXP365 EAM™, the equipment classification can easily be achieved asset by asset using ad-hoc parameters defined for this scope. With a user-friendly, easy-to-implement solution, it is possible to categorize equipment using the Safety, Critical and GMP attributes. These parameters allow managers to organize equipment and take actions on a risk-based priority. Combined with risk-based asset management practices, AXP365 EAM™ dramatically increases control over plant maintenance operational activities and favors the differentiation of the maintenance strategies among equipment.
Interested in optimizing asset management at your pharmaceutical organization? Contact us today to learn more about how our technology was designed to help you improve compliance and productivity.