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by John R. Grum

In their ongoing quest to build a better mousetrap, software developers have combined calibration management with the latest business process developments to create an improved system for controlling calibration and maintaining measurement instrumentation. However, this breakthrough technology is driven by stringent requirements that companies ignore at their peril. Quality standards such as ISO 9001, ISO/IEC 17025 and ISO/TS 16949; regulatory requirements such as the FDA’s code of federal regulations’ requirements for current good manufacturing practices; and everyday business goals such as profitability all have a bearing on the latest trends in calibration management systems.

Similarly, compliance to ISO/IEC 17025 underlies many manufacturing requirements. This standard, mandated by ISO/TS 16949 for calibration service providers, is gospel for original equipment manufacturers. It includes calibration basics along with environmental conditions, measurement uncertainty, proper certificate preparation, calibration technician training and technical competence, and standard operating procedures such as change control.

For FDA-regulated companies, compliance to the FDA’s cGMP drives overall manufacturing requirements, just as compliance with 21 CFR Part 11 drives electronic records requirements. These include using validated computerized systems; retaining secure electronic records; system and data security; system access control; using secure electronic signatures; and user-independent, computer-generated, time-stamped audit trails.

Historically, a CMS provided basic tracking, scheduling and reporting functions. Modern packages offer flexibility and customization to ensure they’ll fit into existing calibration processes. New capabilities include tracking full measurement, calibration and maintenance data; multiple-event scheduling; multiple security levels; and attaching standard operating procedures, certificates, charts and forms to asset records.

New CMS features integrate the latest trends in calibration management with those of business processes, including:

Advancing software technologies

Assessing new architecture technologies

Outsourcing calibrations

Collecting field data

Measuring performance

Centralizing calibration across the enterprise

Standardizing calibration between sites

Advancing software technologies

As regulations become more defined and internal processes are re-evaluated, a modern CMS can increase productivity, manage compliance and improve your organization’s return on its investment. However, upgrades in database, report writing and operating system software must be accommodated by the CMS.

The first step in migrating to a new system is evaluating needs through a user-requirement specification. This is a simple statement of what’s required of the system. By defining the requirements necessary for the calibration management process, an organization can narrow the search for the CMS best suited to its needs. Guidelines for the URS process include:

Emphasizing the required function rather than the method for implementing it

Writing a URS for each function the software will perform

Ensuring the URS will distinguish between regulatory requirements and desirable features

Once the URS is completed, it can be evaluated against different CMS packages and an educated decision made about which is most suitable. Although the process takes time, it helps to ensure a close match between the user’s requirements and the CMS. Other considerations include flexibility, ease of use, reliability and, most important, the technology upon which the system is based.

The technology a CMS vendor uses to develop a software package is crucial. Verifying that the CMS is designed for Microsoft SQL Server or Oracle isn’t enough; organizations must look at the type of architecture used. Growing companies should evaluate whether the software package is scalable. A CMS requires a significant investment of time and money, and it can’t be changed every year to optimize productivity. Therefore, manufacturing companies must evaluate the vendor’s development practices to confirm they’re developing not only for today but also for tomorrow.

Assessing new architecture technologies

CMS vendors are quick to take advantage of new technology to produce state-of-the-art systems. Such software packages provide not only best-in-class feature sets but also the ability to share data in seconds with hundreds of users from multiple locations.

The technology best equipped to satisfy these requirements is an n-tiered Web model designed to distribute the necessary user interaction, computation and storage tasks between the layers of the architecture. Although some latitude exists in the exact number and structure of layers, a CMS is typically broken up into a client tier, a middle tier and a data store--which is further segmented into a data abstraction layer and a database server.

Client tier. This layer is responsible for interactions with the user. In the past, all application users saw the same interface. Today’s users access their data from a variety of devices with various screen sizes and input methods. The client tier must accommodate the user regardless of the device bridging the user to the system.

Middle tier. Also known as the business logic layer, the middle tier is where data are interpreted and business rules applied. Certain types of security and access checks are also performed at this level. The middle tier is considered the brain of the n-tiered system; a Web server offers the best performance.

Data store. This tier includes the task of data storage and retrieval. Once the choice of a database server is made, a data abstraction layer is created to provide the interface between the middle tier and the database itself. Some popular databases include Microsoft SQL Server and Oracle. For its reliability, MSDE is now frequently used instead of Microsoft Access.

By using a Web-based, n-tiered architecture, CMS software greatly reduces network traffic and the burden on client resources while maintaining security and data integrity. Users aren’t directly bound to the data store, as they are with a traditional client-server application. Instead, the middle tier uses connection pooling to enhance both network and software resources. The result is improved performance.

In traditional Microsoft Access database applications, the system slows down as more users log onto the software. Data corruption is typical. With this modern architecture, a CMS can handle hundreds of users without affecting performance. Moreover, as an organization grows, so must its CMS. Application scalability is very important; among other things, it means tremendous cost savings when multiple sites are rolled into one system.

Outsourcing calibrations

One of the biggest trends in manufacturing is outsourcing calibration chores. Limitations in time and human resources generally motivate companies to consider this option. Because a company might outsource all or only a few calibration services, outsourcing itself falls into several categories. The first consists of using a particular company to calibrate specific equipment, which is gathered and routinely sent off-site. The second involves having a company--such as the manufacturer--service and calibrate the equipment. The third is contracting a calibration service company to calibrate the entire inventory on-site. Most companies use a combination of these categories.

Regardless of who provides the calibration services, the manufacturing company is responsible for managing and recording calibrations. A state-of-the-art CMS provides the tools to do this. It can track scanned certificates of completed calibrations, equipment status and location, and reports of money spent on outside calibrations. Metrics on service provider performance are also important factors.

Collecting field data

Collecting and managing both manufacturing and laboratory data is an integral part of today’s calibration process. A CMS must provide the capabilities to easily record such data.

One of the best ways to collect field data is on a notebook PC. Calibration technicians can transfer subsets of instrument records from the main CMS into the notebook-based CMS module. Calibration activities and events are then recorded in the field on the notebook, and the data are transferred to the main CMS. This process eliminates redundant data entry and paper, greatly reducing the risk of error. A notebook PC is ideal because it’s an easy-to-use format, powerful enough to include standard operating procedures as well as captured measurement data.

As the cost of notebook computers decreases and the advantages of eliminating pen and paper are realized, a technologically driven CMS that can provide security features and user options along with a data-collection utility becomes increasingly attractive. For paperless calibrations in regulated industries, robust electronic signatures are also required at the point of data collection.

Measuring performance

Metrics used in calibration management have taken on new importance as companies strive for global competitiveness. Along with current software technology, key performance indicators used in calibration management are proving helpful in optimizing a range of calibration operations. The concept of key performance indicators originated with equipment and facilities maintenance, although the term is a familiar one to computerized maintenance management system users as well.

An enterprisewide CMS provides executive-level management with a window on calibration operations, which in turn supports decision making and productivity benchmarking. It’s therefore not surprising that calibration budgets continue to grow as compliance requirements become more stringent and profitability goals more imperative. Companies are beginning to see the benefits in handling KPIs in the same way they handle their instrument calibrations. Business decisions regarding equipment calibration and repair can be determined from reliable data.

Controlling KPIs also can improve business performance by optimizing maintenance intervals, reducing repair costs, enhancing reliability and increasing productivity. A recent survey from www.eCalibration.com determined the top performance indicators in calibration management. They are:

Productivity measurement

Project and capital justification

Financial performance analysis

Customer satisfaction

Quality and regulatory issues

Centralizing calibration across the enterprise

Enterprisewide systems make the best use of new CMS technology. For example, an enterprisewide CMS enables an organization to host the application at a central location while allowing worldwide access to separate departments and facilities. In a typical installation, the database application is hosted on centralized IT servers, configured and controlled by a corporate quality or metrology group, and used by working groups throughout the global enterprise. The software enables each working group to maintain its own dataset configured to its specific needs--including its own field labels, languages or time zones--while centralizing the overall implementation configuration.

An enterprisewide CMS can reduce calibration procedure writing and management, standardize calibration measurement data collection and retention, and allow for instant communication of management and productivity metrics. This system also functions as a platform for collaborative problem solving, which is especially important in cases where employee input is dispersed throughout the enterprise.

Companies that must follow standards or regulations will quickly realize the advantages of an enterprisewide CMS. All FDA-compliant companies must validate the software they use when making products for public consumption. Validation is an expensive and time-consuming task, but with an enterprisewide implementation, it would be required only at the central host site. If a CMS had been installed at each individual site, then a validation would be necessary for each implementation. An enterprisewide CMS can reduce validation costs by up to 90 percent.

It can also add to the bottom line. Through cost reductions in application licensing costs, corporate IT resources, internal auditing and training, the enterprisewide CMS provides the lowest total cost for corporate calibration compliance.

Standardizing calibration between sites

Although the enterprisewide approach standardizes calibration processes throughout an organization, it’s also possible to implement a CMS using a site-by-site method.

Not all companies can initially deploy a centrally hosted, enterprisewide application. Divisions might want to remain separate from others, an organization might be too diverse or the infrastructure might not be capable of supporting such a system. However, companies could require a single CMS solution for all departments. In such cases, standardization is the answer.

Individual departments within an organization can purchase the same CMS, with each site hosting its own copy. This can be beneficial in several ways. Each facility in a corporation can purchase on its own schedule and within its own budget constraints. Also, policies, procedures and processes can be completely customized for each department. Finally, each site can benefit from the knowledge and experience of other sites within the corporation.

For companies whose ultimate goal is an enterprisewide solution, the site-by-site approach with one CMS is a good start. Given a well-researched standard technology, all sites can easily be merged later into one comprehensive package.

Historically, CMS vendors offered troubleshooting services, infamously known as “technical support.” Today, many CMS vendors offer turnkey service that includes project assessment, system architecture design, systems implementation, validation assistance, data import, report writing, commissioning and training. Companies reduce costs and minimize implementation risks by hiring vendor personnel to install and start up systems quickly and efficiently.

Quality standards, regulatory requirements and business goals drive the needs of today’s calibration management systems. Modern CMS packages offer flexibility, customization and a robust feature set to exceed those needs.

About the author

John R. Grum is the marketing manager at Blue Mountain Quality Resources Inc. Blue Mountain is the validated leader in calibration management software. With 15 years of experience in FDA-regulated and ISO-compliant markets, Blue Mountain offers a complete solution from site assessment and installation to training and validation. For more information, go to www.coolblue.com.