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Life Science Industry Case Studies



EDI has delivered successful projects to four of the top fifteen pharmaceutical companies in the world including Calibration, Mobile, and Inventory.

 

Our dedicated teams of Life Sciences experts have more than 80 years of cumulative industry experience including: Engineering, Analysts, Regulatory Compliance, and Quality.


In the pharmaceutical industry, the management of assets takes on a double role. Not only must they have the capability of producing product, they must also be able to meet rigorous regulatory requirements imposed by regulatory agencies such as the FDA and EU. This creates a situation where Asset Management must not only meet objectives of meeting functional requirements, but regulatory requirements as well. In most industries, a simple redesign of an asset to increase reliability would be a simple engineering redesign and implementation. In the pharma industry, there are quality reviews of every redesign which often results in revalidation activity that can be more costly than the design itself.



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Due to these regulatory requirements, every activity performed in the entire asset lifecycle of Plan, Build, and Operate must be documented.

For years this documentation was performed using paper and manual processes.

Even today, many Life Science companies still rely on many manual and paper processes. The cost of these systems isn’t only due to the labor-intensive process of dealing in paper, but also in researching asset issues recorded on paper and manual logbooks. In implementing an effective Enterprise Asset Management System, EDI concentrates on automating these processes while increasing regulatory compliance. The table below, demonstrates crucial activities in the Asset Lifecycle and the Past approach versus the EDI eLSAM Future approach.

 

Activity

Validation Master Planning

Past Approach

Use of drawings and documents to establish system boundaries, FMEA results are written in a document where product risk from failure and likelihood of failure are recorded. This document is filed in the Document Management System (DMS) where they are seldom utilized by operations.

eLSAM Approach

Create an Asset Structure within the EAM that allows the critical aspects of the asset to be tracked and utilized in the operation of the asset. The asset allows us to define these key points:

  • What the asset does – which translates to product impact
  • What the asset is – that allows us to understand tolerances and material of construction
  • How the asset is configured – that ensures compliance through design is enforced

Activity

Installation and Operation Qualification

Past Approach

The IQ or IOQ as is often the case now is performed using word processing or spreadsheets to record installation and configuration data. This is where the installed assets are inspected and verified that they meet parameters defined in the design documents. Again, these are kept in the DMS where they are, or should be referenced, whenever change is performed on the asset.

eLSAM Approach

Design Requirements and operational parameters are embedded in the functional object where it can be easily referenced whenever change is considered or performed. In addition, the IQ report is built into the system so performance and correction ensures that the EAM has the corrected information.

Activity

Maintenance Strategy

Past Approach

Maintenance strategy and job instructions are developed and recorded in SOPs. The SOPs are stored in the DMS and are assigned to technicians and engineers for reading. The SOPs are updated as strategies are adjusted to meet compliance issues or for maintenance strategies. Personnel are expected to print and utilize the SOPs when performing work, but there are often issues with work performance as the SOPs aren’t always remembered or used while performing work. The typical time for an SOP revision in the industry is 30+ days.

eLSAM Approach

The EAM utilizes Job Plans to capture maintenance strategies and job tasks. The Job Plans have revision and change control enabled to meet regulatory compliance. Full e-sig capability is utilized on the Job Plan. Since the Job Plan is within the EAM, our experience is that a Job Plan revision typically happens within one or two days. This process allows for nearly immediate change when there is a need for maintenance adjustment to compliance issues, or change in maintenance strategy.

Activity

Work Order Review

Past Approach

Work is documented on paper where the paper is reviewed and signed by quality and engineering as dictated by SOPs. Because of the number of work orders that are typically generated in the industry, this review process is often less than optimal and can miss critical documentation issues.

eLSAM Approach

The EAM utilizes Job Plans to capture maintenance strategies and job tasks. The Job Plans have revision and change control enabled to meet regulatory compliance. Full e-sig capability is utilized on the Job Plan. Since the Job Plan is within the EAM, our experience is that a Job Plan revision typically happens within one or two days. This process allows for nearly immediate change when there is a need for maintenance adjustment to compliance issues, or change in maintenance strategy.

Activity

Redesign and Testing

Past Approach

Redesign of a system or asset is performed in the Change Management system. This is where the change justification and the related documents are identified and tracked. However, because there is typically no link to the Maintenance Management System, the physical work performed isn’t well documented or tracked. Updates to the SOPs used for Operation and Maintenance are updated and notification is sent to technicians to read up on the new maintenance strategy. SOP reading compliance is a constant challenge and there isn’t an effective method of enforcing that technicians performing the work are caught up on their SOP reading.

eLSAM Approach

The EAM utilizes Job Plans to capture maintenance strategies and job tasks. The Job Plans have revision and change control enabled to meet regulatory compliance. Full e-sig capability is utilized on the Job Plan. Since the Job Plan is within the EAM, our experience is that a Job Plan revision typically happens within one or two days. This process allows for nearly immediate change when there is a need for maintenance adjustment to compliance issues, or change in maintenance strategy.

Activity

Reliability Centered Maintenance and Risk Assessment

Past Approach

Because of the manual processes, RCM programs traditionally require a high labor commitment. While all maintenance deviations require root cause investigations per regulatory agency requirements, these investigations rarely get at the true root cause. Instead they frequently land on the cause that is a “man” type and retraining is the corrective action. This translates into lots of training to folks where there is so much documentation to read and apply, that unless people have years in an area, they can hardly be expected to remember. Risk assessment is often performed after an asset failure where emotions are high and severity of risk is overstated, resulting in skewed data.

eLSAM Approach

An EAM configuration is utilized where severity of a failure is tied to the problem on the Problem code of the failure class. This number is derived as part of risk assessment performed during the validation planning cycle. The cause of the failure provides the detectability of the failure and the occurrence is tracked directly in the EAM. This allows us to calculate a risk priority number in real time, ensuring that the highest system risks to the organization is objective rather than subjective. Utilizing the failure codes (PCRs), we are able to quickly derive meaningful data for driving an effective RCM program. Real time risk analysis, allows the engineering department to focus on the systems that have the highest impact to the business. Direct ties to approved spare parts on assets minimizes the risk due improper installation of spare parts on equipment.

 

Implementing and operating Enterprise Asset Management in the Life Sciences industry involves unique challenges across laboratory, manufacturing, and facilities departments. Our experience in the Pharmaceutical/Life Sciences markets has allowed us to develop and fine-tune the above solutions to operate under FDA and other foreign regulatory agencies.


 

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