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