Leveraging Asset Performance Management in Pharmaceutical Manufacturing

Pharmaceutical companies today are faced with challenges such as global competition, reduced patent protection, the rising cost of drug development, and FDA initiatives. The convergence of these factors has caused increased strain on corporate resources and has raised the very important question: how can pharmaceutical companies possibly get a return on their billion-dollar research and development (R&D) investments?

THE COMPLEX TASK OF MANAGEMENT

Inevitably, when something goes wrong for facilities managers, the issue typically involves the company's asset management operations. If a piece of equipment breaks down, is not where it is supposed to be, or, worse yet, is not in compliance with federal regulations, the problem is usually a function of faulty asset management.

Effectively managing capital assets has long been a difficult task for facilities managers in the pharmaceutical industry. Managers of manufacturing facilities may be responsible for thousands of assets, and optimizing the deployment and operation of all these assets requires meticulous attention to detail. Facilities managers in the pharmaceutical industry in particular must meet the requirements set forth by regulatory agencies or face severe consequences — including fines, plant closings, and lost revenue.

In 1997 FDA introduced the regulations contained in Title 21 of the Code of Federal Regulations Part 11 (21 CFR Part 11).¹ These regulations, which pertain to electronic records and electronic signatures, have been a driving force behind streamlining facilities management processes. While some view Part 11 as a regulatory hindrance, it was in fact designed to establish a set of guidelines for improving security and efficiency within the drug development and manufacturing processes. Employing electronic signatures and electronic records as specified by Part 11 yields numerous benefits, including improved efficiency, faster time to market, better quality, and risk avoidance.

In a pharmaceutical manufacturing plant, the failure to meet regulatory requirements can be devastating. The most severe penalties for regulation infractions result in a plant shutdown, which can have serious implications for production and revenue. There are many ways a company can become compliant, but it is important that the costs of compliance — in terms of money, labor, and interruptions to workflow — are kept to a minimum.

With increasing competition and the demands of Part 11 compliance, companies must streamline business processes and cut costs in order to stay ahead. Asset performance management, which may not previously have been part of a company's strategic planning, is now viewed as a critical component in speeding the flow of new drugs into the marketplace.

SEARCHING FOR A SOLUTION

From the standpoint of manufacturing's best practices, pharmaceutical companies reap greatest benefits from regulation-related solutions that have minimal impact on production throughput. Solutions that allow for compliance and ease of use are the most effective choices for companies looking to pass inspection without sacrificing productivity.

Traditional asset management consists of add-on maintenance modules, but these can be difficult for operators to use. At the same time, the task of bringing older computerized maintenance management system (CMMS) programs and home-grown calibration systems into Part 11 compliance can be prohibitively expensive and time-consuming. Faced with these challenges and needing to satisfy changing production requirements, a pharmaceutical company may even consider buying new plants or installing new equipment. An alternative approach, however, involves rethinking and re-evaluating existing equipment and asset management.

Evaluating equipment performance and processes warrants certain considerations, such as:

• Productivity — How can assets be improved to get more product to market faster?

• Capital assets — What equipment is in use, what is in stock, and what should be replaced?

• Operating risk — Are there gaps in regulatory compliance and risks related to Part 11?

• Operating cost — How can uptime best be maintained or increased while reducing or minimizing the costs?

Web-based asset performance management provides pharmaceutical manufacturing with a number of advantages over traditional asset maintenance and tracking. With traditional paper-based processes, it is difficult to demonstrate that data are securely and accurately captured, because paper records are cumbersome and data on paper is difficult to store, retrieve, and access. Moreover, the use of paper records can cause regulatory compliance issues when a company is unable to locate and deliver required product and process records and associated information.

The use of electronic information is a substantially more efficient and more secure means of managing the huge volume of data associated with manufacturing processes. For multi-plant manufacturing, web-based systems allow companies to deploy a solution on a central server, with end-users accessing the system via a secure, encrypted Internet connection. The need for paper-based tracking is eliminated, and electronic systems support compliance with Part 11. Furthermore, web-based asset performance management provides managers with complete visibility into the state of their assets, parts, and processes across all locations. This visibility reduces repetitive work orders, unnecessary purchasing, and can help increase the likelihood of successful FDA inspections.

CHOOSING AN ASSET PERFORMANCE MANAGEMENT SYSTEM

When choosing an asset performance management system within the context of addressing regulatory compliance, it is crucial that a company note big-picture issues and then focus on critical business areas marked for improvement. First and foremost for the project, managers must identify the key goals and objectives that depend most heavily on an asset performance management system. Specifically, they should look at operational objectives such as supply chain and throughput, as well as tactical objectives such as safety procedures and consolidation of vendor parts. This advanced planning will pave the way for a successful solution implementation.

The Datastream 7i asset performance management solution is an example of a flexible and modular system that allows companies to meet regulatory requirements, increase efficiency, and grow their bottom line. It boosts the efficiency of maintenance, calibration, inventory control, and purchasing operations so companies can engage in best practice maintenance management in a manner consistent with the high regulatory compliance standards of the pharmaceutical industry. Companies can improve their facilities management processes with Datastream 7i through preventive-maintenance revision control, record and data availability, and calibration.

Datastream 7i includes built-in preventive-maintenance revision control features to help ensure document integrity, which is an important requirement in achieving 21 CFR 11 compliance. These features allow users to protect and preserve documented maintenance procedures, including job instructions, material needs, frequency of tasks, inspection routes, routines, and preventive maintenance requirements. If a change to an existing document is requested, the user must create a new version of the document, which is then routed to a pre-defined group of supervisors who electronically sign off on the new procedures before activation.

Record and Data Availability

Datastream 7i gives companies the ability to print and export records in various formats, including Microsoft Excel spreadsheets and Adobe Acrobat PDF files. In addition, Datastream 7i is one of the only asset management software products that allows companies to compile a record library that follows progressive changes. This provides companies and FDA inspectors with accurate documentation of each alteration in the system.

Companies that use electronic signatures must ensure their uniqueness, security, and validity. An advanced 21 CFR 11 Datastream 7i module implements electronic signatures through a pop-up screen whenever an action, such as a work or purchase order acceptance or rejection, requires a signature.

Calibration

Pharmaceutical manufacturing facilities need to test and verify instrument accuracy against a known standard for compliance. In such a heavily regulated industry, companies cannot tolerate any asset measurement inaccuracies. Having a fully integrated calibration asset-management tool is an ideal solution to incredibly demanding calibration requirements. Proper calibration is especially critical where inaccurate measurements can cost lives, waste precious resources, and expose companies to devastating regulatory penalties. Calibration data need to be integrated with other business areas, giving companies the ability to distinguish among instruments and their positions to track replacements, track calibration costs, and access the system remotely through mobile capabilities. With Datastream 7i, companies successfully address calibration compliance requirements, increase the quality and reliability of manufacturing processes, and optimize and extend the useful life of calibration equipment.

Additional System Features and Functions

Datastream 7i is designed to work on multisite and multiorganizational levels. Companies with multiple manufacturing sites, or different departments at the same site, can work from the same database. As a result, managers can compare performance among different plants or divisions in different countries.

This feature is particularly useful for inventory management. For example, if a plant is out of a spare part, but another plant in the company has one, inventory managers can see this immediately and can take action to optimize spare parts usage. One customer chose Datastream specifically because it integrates maintenance, calibration, and inventory functions and provides the trending needed to comply with 21 CFR Part 11.

As a solution that addresses all aspects of compliance and is easy for the end user to understand and utilize, Datastream 7i is an effective asset performance management system that provides improvements to information security. These improvements include:

• Electronic records and signatures: The solution offers the ability to electronically track and sign off on maintenance and procurement documents.

• Use of passwords and unique IDs for individual users: With the password aging function, a password will expire over a pre-determined number of days. With the password lockout function, after entering a certain number of mismatched user IDs and passwords, a hacker will be locked out.

• Identifying and tracking any tampering of records with a back-end security system: Administrators are provided with a way to look for suspicious activity.

• Audit trail capability: The system tracks who changed a document, when, and why.

The Datastream 7i system can also provide management with a view into plant floor operations, improving control over capital projects, resource allocation, and activities alignment. Datastream has a dashboard-type graphical interface that maximizes visibility, allowing users to choose key performance indicators (KPIs), then view color-coded gap histories between real and desired performance in such areas as equipment calibration and condition, stores issues and returns, repairable spares, and time required to perform a given function.

Thus, when an action such as calibration is required, users can see the gap between the time it actually took and the time allocated. Managers can use the software to view color-coded gap histories, and can then go to the system database, determine what factors led to the situation, and improve Part 11 compliance. Color-coded KPIs can display the value of spare parts stocked in different plants, compared with the turnover of each part to determine whether an item is overstocked or understocked.

RETHINKING PERFORMANCE MANAGEMENT

Any asset performance management system should address all aspects of FDA compliance. In addition to addressing compliance issues, such a system must contain features and capabilities that contribute to the pharmaceutical manufacturing process and are easy for the end user to understand and utilize.

Datastream 7i is an effective way for pharmaceutical and biotech manufacturing plants to automate maintenance, procurement, and support services, while addressing requirements found in 21 CFR Part 11. Datastream 7i is a three-tier application completely designed and built around the flexibility, speed, and reliability of the Internet. Its web-based architecture ties multiple facilities together and gives managers complete control and visibility into all of their assets, regardless of location. With Datastream's application hosting services, customers get a single point of contact for the complete asset management application — handling all software, hardware, and support concerns. Overall, this architecture enables faster and easier product deployments, greater security and reliability, and optimum scalability.

Datastream 7i offers an effective way for manufacturing plants to automate procurement and support services, while addressing issues such as 21 CFR Part 11. This approach can deliver significant savings while providing greater returns from asset investments without disruption to workflow. The end result is that with a solution such as Datastream 7i, facilities managers can implement business process improvements via a quality asset performance management system designed both for practical use and for meeting regulatory requirements. ?

REFERENCES

1. 62 Federal Register 13430 (1997) (codified at 21 CFR Part 11). Available at: http://

www.fda.gov/ora/compliance_ref/part11/frs/background/11cfr-fr.htm

and http://

www.fda.gov/ora/compliance_ref/part11/FRs/background/pt11finr.pdf

.

Matt Langie is director of product marketing at Datastream Systems, 50 Datastream Plaza, Greenville, SC 29605, 864.422.5001, fax 864.422.5000, mlangie@datastream.net.