Xybion EAM Solutions

IBM Maximo® Best Practices

Integrating Calibration Data and Processes in IBM Maximo®

844 291 4430 I www.xybion.com I 2000 Lenox Drive, Lawrenceville, NJ 08648

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Contents Executive Summary ......................................................................................................................................................... 3

Equipment Calibration Challenges .................................................................................................................................. 3

21 CFR Part 58.63: Maintenance and Calibration of Equipment ................................................................................ 4

The Importance of Integrated Calibration Data ............................................................................................................... 4

Key Features of Maximo® v7.6 Calibration Functionality ................................................................................................ 5

Supporting the Growing Use of Mobile ....................................................................................................................... 6

Xybion Solutions for Integrating Calibration Data ........................................................................................................... 7

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Executive Summary

Akin to typical laboratory and manufacturing process validation, the calibration of instruments and computers is equally significant to meet the Good Manufacturing Practice (GMP) requirements. Any discrepancies in equipment calibration, especially in Life Sciences, would lead to regulatory risk and would even call into question the organization’s product integrity.

In such scenario, many companies are counting on enterprise asset management solutions to meet the calibration needs. However, the disconnected processes in equipment maintenance and metrology are leading to greater duplication of calibration efforts.

In addition, multiple systems and data duplication are creating gaps in the process of equipment maintenance and calibration.

This whitepaper helps you identify the calibration challenges, how an asset management solution can simplify the complex processes and finally, how asset management solutions can leverage Xybion’s audit solutions.

Equipment Calibration Challenges

Although both the groups have same goal (to keep production equipment up and running as designed in a cost-effective manner) they are rarely on the same page. This could result in repair and maintenance scheduling conflicts, duplication of effort and general inefficiencies.

The Rising Cost of Disparate Data Repositories for Metrology:

• Duplicate Data Management

• Additional Hardware Requirements

• Higher Internal IT Costs \ Duplicate Data Entry

• Duplicate Database Maintenance

• Slower Response Time

• Lowered Visibility into Business Problems

• Additional Annual Software Maintenance

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21 CFR Part 58.63: Maintenance and Calibration of Equipment

As per FDA’s 21 CFR Part 58, a mandate for GLP for nonclinical laboratory studies, the organizations are entitled to comply with Sec.58.63 for maintenance and calibration of equipment. Here, the equipment used for the production should be adequately tested, calibrated, and standardized. However, the disparities in equipment maintenance and metrology may lead to non-compliance. Additionally, inadequate maintenance and calibration procedures make organizations highly vulnerable to 483s and warning letters.

Additionally, there might be delays in time-to-market and may leave you open to other risks ranging from increased liability to patient safety.

Some of the top five risks for Medical Equipment Calibration Programs include;

• Insufficient Expertise

• Manual Methods

• Paper Trails

• Lack of Visibility

• Irregular Calibration

The Importance of Integrated Calibration Data

In this scenario, consolidation of these two key functional areas within an organization will improve the operational efficiencies; lower the initial and ongoing cost of ownership for the EAM system as well as better overall product quality.

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Bringing the groups together can consolidate duel management of the groups by eliminating conflicting goals, separate budgets and scheduling conflicts. Implementing and maintaining one EAM system will lead to lower overall costs providing a faster return on investment for the system. Additionally, using one system to manage these roles can eliminate conflicting data quality, thus leading to smoother audits. Overall, this consolidation will lead to better day-to-day operations within the group.

As companies look to consolidate resources and run production as lean as possible, the trend is to manage areas such as equipment maintenance and calibration together. The question becomes how to do that while still providing the metrology professions with the tools they need?

The ideal solution would be an industry leading Enterprise Asset Management (EAM) system that incorporates the metrology-specific functionality required to effectively manage the calibrations.

Luckily IBM has been paying attention to the industry trends and has greatly improved the calibration functionality in its latest world-class EAM offering, Maximo® v7.6. Where earlier versions of Maximo® have covered some of the basic needs for tracking calibration, v7.6 provides real depth of features to allow completely integrated management of both equipment maintenance and calibration.

Key Features of Maximo® v7.6 Calibration Functionality

Complete automation of the calibration process integrated with Maximo® Asset Management allows one system to schedule calibration events, perform the work and record the calibration data, including as found and as left data, manage out-of-tolerance events and issues corrective and emergency work to be performed. The Maximo® Calibration module also provides complete instrument life-cycle tracking including instrument induction, complete instrument work history including calibration data.

Full Forward and Reverse Traceability

IBM Maximo® Calibration provides full forward and reverse traceability for compliance to best practices in metrology as well as any regulatory compliance that may be needed. Should a standard be found to be out of tolerance, it is extremely important to be able to identify all instrumentation that have been calibrated with that standard, since it’s last calibration date.

User-defined Calibration Data Sheets

The Maximo® Calibration solution also supports the creation of user-defined calibration data sheets. User-defined data sheets allow business or industry best practices to be followed by record whatever calibration data is required. The data sheets can be configured to linear and non-linear instruments, and support standard calibration calculations like % of span, % of reading, and average and standard deviation of readings as well as others. Repeatable and manual test points are also supported.

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By fully integrating with the overall Maximo® Asset Management solution, the Maximo® Calibration Solution takes advantage of the best features of that system, including the automatic generation of work orders as scheduled. Notifications can also be generated based on out-of-tolerance findings, providing valuable oversight to corrective actions.

Supporting the Growing Use of Mobile

Maximo® Mobile Work Manager now supports calibration as well. This allows calibration technicians to perform their work and record the data electronically eliminating paper records and the storage costs and data retrieval headaches associated with paper behind.

Paperless Systems

One of the biggest industry treads in asset management as well as calibration is the drive towards paperless systems. Data heavy calibration records are especially useful since once that data is recorded it can be used for trending and interval analysis to further improve quality system efficacies and accuracy. Maximo®’s mobile solution has long been considered an industry leader, and by fully integrating calibration functionality companies can leverage their investment to take advantage of its deep functionality across all functional roles.

The Maximo® Calibration solution has also been built out to include many other core calibration functions including loop calibrations, calibration tool management, calibration job plan tracking and work order tracking, data sheet template creation and many more.

The full integration with Maximo® Asset Management also provides superior reporting capabilities, further

enhancing data analysis and over management oversight.

The full and mature feature set of the Maximo® Calibration solution, fully integrated with Maximo® Asset Manager in version 7.6, eliminates the need to have competing systems in place for calibration and equipment maintenance. Consolidation of these similar tasks that share a common goal will improve operating costs; eliminate system and data redundancies and increase quality and compliance.

While in the past it may have made sense to implement calibration specific systems in order to meet operational and compliance needs, it is no longer necessary. IBM Maximo® Calibration is more than capable of exceeding the most stringent requirements in the most demanding industries, including Life Sciences, Nuclear, Transportation, Oil & Gas and Utilities.

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Xybion Solutions for Integrating Calibration Data

Xybion is a leading provider of value-added services, training, project management and add-on software components for IBM Maximo®. Our BRIE (Bulk record import/export) solution along with CAT (Comprehensive Audit Trail) can assist your company in integrating calibration data into IBM Maximo® by getting data into the system in more structured manner with the BRIE solution and by ensuring that your calibration data and processes adhere to specific industry regulations with our CAT solution.

Our team of Maximo® experts is well positioned to ensure a smooth transition from current point solutions for metrology to a more streamlined, cost effective approach with an integrated Maximo® platform.

About Xybion

Xybion offers the deepest domain expertise in the industry for IBM Maximo® via our Enterprise Asset Management practice. We have been a leading provider of IBM Maximo® products, services and training for many years and have cultivated a reputation for excellence in our industry. Our Maximo® Products, CAT and BRIE have helped numerous companies improve the performance of their Maximo® installations.

Xybion Corporation was established in 1977 as a solutions provider for Life Sciences companies and research organizations worldwide. Our company has grown through strategic acquisition and organic customer growth and today, we are positioned as a global provider of integrated data, quality, compliance and asset management solutions for fortune 1000 corporations.

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Xybion provides four primary solutions that can be utilized as stand-alone or integrated offerings. These include quality and data management, pre-clinical data management, enterprise asset management and Global Services Delivery for development, testing and validation.

Our team is well positioned to help you extract the highest level of ROI from your enterprise asset management investment. Our EAM services will ensure whether you have Maximo® installed the right way, the first time. Further, if you are looking to upgrade Maximo®, we can assist in getting your project completed on time and under budget. The Xybion team strives to ensure your Maximo® project is on time and on budget. Our solutions are designed to help you achieve the following business benefits:

• Reduce Implementation Risk

• Maximize Your Maximo® Investment

• Rapid Deployment

• Leverage Current EAM Best Practices

• Lower Total Cost of Ownership (TCO)

• Ensure Sustained Compliance

• Improve Asset Management

• Operational Efficiencies

Xybion operates from locations in the US, EMEA, Canada and India.

Learn more about us at www.xybion.com

References https://www.ibm.com/support/knowledgecenter/SSLKT6_7.6.0/com.ibm.mam.doc/overvie

w/c_ctr_wn_mam_7.6.html

http://www.tek.com/service/why-calibrate-your-instrument

http://www.pci-llc.com/wp-content/uploads/2013/03/PITTCON-2013-Maintaining-

Calibration-Programs-Compliance-Perspective.pdf