Asset Management for cGMP Facilities
What is enterprise asset management for GMP facilities and why do our clients need it?
An enterprise asset management (EAM) system is a software product used to track the operation, maintenance, calibration and disposal of assets.
One of the challenges unique to the life sciences industry is the requirement to adhere to many FDA regulations. During routine FDA audits, not only must companies be able to show the traceability of raw materials and inventory, but they also must be able to demonstrate the traceability of process equipment. This includes the associated calibrations and preventative maintenance records.
Owners must document compliance with the equipment manufacturers instructions for installation, calibration, testing and output validation for each piece of equipment in their facility. This includes compliance with the manufacturers maintenance schedule, and documenting each step of the change control process required for taking a piece of equipment offline while performing this maintenance.
This complex process requires significant time and energy. Using an outdated paper-based accounting and tracking system is arduous and prone to mistakes and lost data. Paper-based records systems entail multiple steps and rely on end users to input, review and approve the data. Paper based record systems also must be stored according to a specific set of criteria. During an FDA audit, any of these critical steps not properly documented can lead to the issuance of an FDA 483 warning – citing the observation of violations of the Food Drug & Cosmetic Act.
Converting record keeping from a paper-based system to an EAM, or software-based system allows for greater accuracy and an easier, more streamlined process – but it can be tricky – there is no “one size fits all” solution. Different organizations have different proprietary assets, and will need the system to function differently, and will need varying degrees of staffing to support the transition. Three steps have been identified in successfully rolling out a project of this kind:
1. Define the Project Goals:
A project charter will help ensure the success of the EAM roll-out. This should include a review of prior FDA audit observations to prioritize what the EAM system should address – there are often multiple areas. The implementation is planned in phases, beginning with inventory and asset management, with subsequent phases involving streamlining and approving business processes.
2. Define the Project Risks:
It is crucial that all stakeholders be intimately involved in design sessions to ensure the system will function according to end user requirements. After all, if the information designed into the system is inaccurate, the output data will be inaccurate as well.
There is also the risk that the new software system may not align with existing software systems, which could affect integration between them. In addition, limited resources could impact the project timeline and scheduled completion. Each of these factors must be carefully considered and planned for.
3. Define the Project Deliverables:
Once the first two steps are completed it will be possible to define the phases leading to conversion to a fully functional and validated EAM system which will enable the client to better comply with FDA and equipment manufacturer’s documentation requirements.
Any company contemplating an upgrade to their records keeping system needs to have an experienced guide, like Hereva, to help ensure the success of a robust EAM system tailored to their individual needs and requirements.