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by Janet Jacobsen

With compliance initiatives such as ISO 9001, ISO 14001 and the Sarbanes-Oxley Act on the rise, and more federal and state regulations likely to follow, most quality managers will readily admit that document control will become even more problematic in the future. Using a paper-intensive, manual process for managing controlled documents and records is time-consuming and expensive. Although stand-alone electronic systems can strengthen the bottom line, simplify business and keep it on the right side of auditors, they are almost impossible to control because unauthorized users can change and distribute the stored records. Thus, managers must find something to eliminate the paper chase and help create and maintain a highly efficient and secure enterprisewide quality system.

The new breed of document management software promises to do just that. It not only provides document control functions but also enhances the processes used for almost any type of record, including corrective and preventive actions, change control, audits and surveys, customer complaints, training and calibration. Through sophisticated reporting modules such as charting, data roll-up and quality alerts, upper management can easily access critical data that affects bottom-line performance. However, with myriad software choices and features available, the problem shifts from solving the document control dilemma to choosing the right solution for your organization. The following tips should help narrow your choices.

Insist on flexibility

“You definitely want a document management system that’s flexible,” advises Glenn McCarty, CEO of EtQ Inc., a quality, environmental, and health and safety management solution provider. “The software should be able to mimic the exact way a company does business, as documented in its existing procedures, and support multiple document types and records, each with their own configurations.”

Today’s software market offers flexible packages to guide companies toward compliance with ISO 9001:2000, good manufacturing practices and Sarbanes-Oxley Act standards and regulations. Look for features such as a flexible workflow configuration that routes documents and records automatically from one step to the next using a centrally stored location. Check to see if the software offers easy-to-use tools so that users can configure the workflow as an administrator without programming. For maximum flexibility, consider workflow tools that enable a “power user”--typically a quality or compliance manager--to access the system and configure the steps, form layout, keywords and the like to match each business process.

Selecting flexible, user-friendly document control software was a top priority for the Pall Corp., which produces filtration devices for drug discovery, drug delivery, and other medical and laboratory markets. The facility selected EtQ Solutions in November 2002. “We were able to set up the document control system to fit our needs and ways of doing things rather than having to change our processes to fit a system,” says Howard Distelzweig, Pall Corp.’s implementation coordinator for their Ann Arbor, Michigan facility. “Using document control software makes the process much easier to control and potentially much quicker and more responsive.”

Familiar, versatile interfaces

With today’s demanding production schedules, lean budgets and reduced work forces, managing a quality system is challenging enough without having to learn a new software program. Once you’ve selected a software program, you’ll have to train your employees to use it, and most people are reluctant to change. Consequently, more quality professionals are looking for software with familiar interfaces--whether it’s e-mail, Microsoft Office programs or a Web browser interface--to ease the transition and make users comfortable right from the start.

A Web browser-based system provides a familiar and versatile interface and reduces the need for extensive employee training, a benefit to organizations such as Pall Corp. “For the most part, setting up the system, maintaining it and making needed modifications can be done by the quality department rather than IT personnel,” Distelzweig reports.

Statistics show more than 86 percent of organizations use Microsoft Office tools to document what they do. Integrating document control software with current tools such as Microsoft applications is key to avoiding the “detach and attach game.” Look for Microsoft integration tools that allow document control system forms to integrate seamlessly with Microsoft Office applications such as Word, Excel and PowerPoint by storing document files as attachments in Web databases. Users can read, edit, preview and update documents in familiar Microsoft Office programs, then automatically integrate the data into the controlled forms and right into the workflow. This level of integration goes far beyond a simple “mail merge” and establishes a secure exchange of data between the attachment and the Microsoft file.

When it comes to finding a familiar interface, it’s hard to beat e-mail because most employees are familiar with this technology either in the workplace or at home. Many leading document control software packages offer an e-mail notification tool through which employees are informed of their assigned tasks. In a flexible workflow environment, e-mail notifications give assigned users access to specific documents at various stages in the document’s approval process. By using already familiar e-mail tools and providing immediate access to the assigned work, organizations can create work environments where document management tasks are responded to in a timely fashion.

Escalation and delegation management

While escalation and delegation tools are key to a paperless document creation and routing system, human nature can’t be ignored in this process: People procrastinate. Consider software that provides an escalation management engine to act as a deadline manager, ensuring that assigned tasks--such as corrective action requests--are finished on time.

Leading software programs feature an escalation database to monitor date fields, such as due dates, that a user defines within every database. The escalation management engine provides a mechanism for sending follow-up e-mails to employees, reminding them to complete the assigned task before the deadline. But what happens if the reminder e-mails are ignored, and the work isn’t completed on time? The procrastinator might expect a visit from his or her boss--because the e-mail notification is escalated directly to the employee’s supervisor.

No procrastinators in your organization? Chances are that your employees do use their vacation and sick days, so a software package with delegation management capabilities is a valuable tool. When employees are away from the office, a delegation utility automatically reroutes assignments to a preapproved delegate. Both escalation and delegation are business tactics that depend on an intelligent workflow system, one that can route documents based on conditions and business rules configured by the user.

Streamlining employee training

Integrating a document management system with a training system can be a significant benefit of document control software, but it’s often overlooked. Although software can automate the flow and publishing of documents, employees must still do their parts to keep the process moving forward. Hence, they require training. Prominent quality and compliance management software companies have integrated their modules to streamline employee training. These training tools allow a user to schedule training on specific documents or records for each employee or department. The assigned employees receive e-mails with instructions on what training is required and when. The employees may then access the document, review it and complete the self-certification. Through this process, the organization gains a trained and knowledgeable staff in a short period of time. Look for software with automatic links to training activities; once employees have completed training on a document or record, you can then configure the system to update all training records automatically.

Using reporting tools

Once a document control system is in place, it’s crucial to be able to provide data about it to improve existing procedures. Building intelligent reporting tools into a document control system is vital to understanding the effect a quality system has on the company.

EtQ Solutions, for example, includes a reporting module consisting of three tools--charting, data roll-up and quality alerts--for gathering and reporting on information. First, a charting tool allows users to chart and report on data using multiple databases and fields. They can create chart templates and, using a familiar interface such as Microsoft Excel, display the data. Additionally, users can create templates and save them to avoid keying in queries each time they create a chart; instead, they can access the templates through the document control system. Viewing present and historical data is just a click away using this type of charting tool.

Another valuable reporting tool is designed to roll-up data from multiple applications to generate global reports and create an information portal. Many organizations have multiple sites, some with locations across the country or world. Expecting managers to scramble from location to location to check how many documents are still in the review cycle, for example, would be counterproductive. A roll-up utility allows users to create multisite reports by taking data from multiple databases and rolling them up into one master database for enterprisewide reporting and portal display.

A third and rather unique reporting tool that can benefit a quality system is quality alerts, or exception reporting. This is a special exception report that automatically notifies specific employees of recurring events as defined by the user. For example, you might want to set up alert criteria on how many corrective action items are still open. However, if you have several thousand documents and procedures across three or four facilities, looking into each database for this information just isn’t practical. With a quality alerts tool, you can set up criteria such as, “I want to be notified before this date if I have pending corrective actions at my three locations.” You would then receive e-mail notification if, and only if, this event occurs.

Handling document changes

Inevitably, procedures, policies and standards change, but that doesn’t mean your document control system should be without an established procedure. It’s critical to integrate a change request process into your document control system by creating a workflow-enabled process for changes.

Look for software that allows you to issue a change request directly from the completed document. This request then initiates a workflow for making the revision to the document. Only after the change control workflow is completed will the existing document be archived, e-mail notifications sent to a distribution list and the revised document become the “live” version.

This capacity to make changes to documents while the document under revision remains operative is a key feature when selecting software. Without this feature, you’ll lose access to the document under revision while a change request is underway. This is especially significant if you make frequent revisions to controlled documents.

Managing compliance

For a quality practitioner working in industries such as pharmaceuticals or medical device manufacturing, compliance is an integral part of the job. FDA and other government requirements mandate that specific security protocols be properly used in order to achieve compliance. Document management software can provide the necessary tools to comply with audit trail, electronic signature and electronic records requirements of standards such as the FDA’s 21 CFR Part 11. When selecting a software solution to ease compliance issues, look for these features:

Electronic signature binding--Automatically and securely binds the authenticated user’s electronic signature required to sign on to the system

Audit trail--Should include a field’s old value, new value, name of the user who made the change, date and time

Controlled/secure access--Controls information access by user name, ID, password, form, form selection, field and workflow

Compliance package--Comprehensive validation documentation as an integral part of the software implementation process

Enhanced password security--Automatic password aging and warning periods, as well as protection against repeated attempts to log in with incorrect user names and passwords

Enhanced field audit trail--Allows users to “mouse over” fields within the forms, displaying the audit trail for that particular field

Looking ahead

As standards are revised, customer specifications changeand various methodologies evolve, companies must adapt quickly. Imagine spending 100 programming hours and $200,000 to customize a document control system to match eight different workflows and then learning a month later that you need 10 workflows with an extra step in each. You’ll go bankrupt from programming costs before you get a process that makes sense. Document control software must have the flexibility to change with your business.

Look for software that provides intelligent reporting tools, a mechanism to streamline employee training, a change request system, a variety of tools to manage regulatory compliance, easy integration with existing business interfaces and most of all, a flexible configuration. It’s especially important that the software you select can expand your document management system beyond just basic document management to include workflow-based processes such as corrective action, nonconformances, deviations, calibrations and much more.

By ensuring that your various workflow-based systems can link and integrate, you’ll gain not only an efficient document control system but also a streamlined corrective action or audits system that ties into an enterprisewide initiative for managing compliance. By taking time for careful and thorough research of your options before purchasing document control software, you’ll be well on the way to eliminating the paper chase.

About the author

Janet Jacobsen is a freelance writer and editor who covers quality and compliance issues.