Auto-Numbering
Complaint
File No's are automatically assigned by the system when a new file
is created. Numbers are always guaranteed to be consecutive even in
the event of errors or other mishaps.
Customize
the format of the Complaint File No. using the Configuration Settings
panel. The Configuration Settings panel gives you complete flexibility
in creating a number sequence that can include a date portion,
a character portion and an incremental number portion. You can chose
the starting sequence number to be 1 (default) or any other positive
number.
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Auto-Emails
Easily
customize the system to alert an individual or group via email when
an important event occurs. Many Events are tracked by Complaint Master
and can be used to trigger automatic email notifications.
The
following is a sample list of Events that can be used for this purpose:
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When
the complaint record is created |
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When
the investigation is assigned |
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When
the investigation is completed |
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When
a complaint record is closed |
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When
an Adverse Event form is created |
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When
correspondence is sent to the customer |
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Electronic File Attachments
Attach
related documents to a complaint record and share this information
with all other authorized users. Using the Attachments panel users
can attach electronic files such as a scanned documents, images, Word
documents or a saved email. All attached electronic files are time-stamped
with the day and time the file was added and displayed in chronological
order.
By having
all relevant information linked with a complaint, users from different
sites or across the globe can easily access the information they
need and work in a distributed fashion.
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Document Templates
Using the
Templates panel users can select from a list of customized templates
to create new documents. Documents created using templates can merge
data from Complaint Master into the document. Users can create Custom
Letters, MDR Forms, Evaluation Forms, etc. These Microsoft Word Templates
can be customized to the specific needs of the company including
logos and specialized macros.
Complaint
Master uses an industry standard word processor, Microsoft Word,
to help users create richly formatted documents. A side benefit
of using Word as the document/template creation tool is that documents
created by the system can be shared with other users that do not
have access to Complaint Master. Other features available with the
tool include Spell Checking, Specialized Formatting Options, Form
Controls and Macros.
Some
of the document templates provided with Complaint Master include:
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Acknowledgement
Letter |
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Results
Letter |
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General
Memo to File |
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MedWatch
Form |
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Vigilance
Form |
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Scan Documents
Scan documents
or color pictures and automatically attach them to a complaint record.
Scanned documents attached in this way can be emailed or faxed from
the system to employees or external customers.
Complaint
Master supports TWAIN compliant scanners and uses a compressed file
format to minimize file size.
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Integrated Email
Complaint
Master comprehensively integrates Email to provide notification and
alert services to enhance the complaint handling process.
Complaint
Master supports the most popular Email Systems in the market today.
Selecting an Email System is as simple as selecting one from the
list. This wide support for email systems ensures that campaniles
will not loose email functionality if they changes email systems
in the future.
The
list below is a sample of supported Email systems:
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Lotus
cc:Mail |
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Lotus
Notes |
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Microsoft
Exchange |
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Microsoft
MAPI |
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VINES |
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Internet
Mail (SMTP/POP) |
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Novell
GroupWise |
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Multiple Facility Support
Complaint
Master has Multi-Facility support which allows large corporations,
with several sites, to track complaints separately (i.e. by Facility).
Configuring different facilities is easy to setup and can be expanded
as new facilities are added to the business. Users can quickly filter complaints
by facility by selecting the facility from the drop-down ListBox.
Complaint
Master relies on the Auto-Numbering
service to automatically generate the next sequential file number
for a facility.
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Complaint Workflow
Complaint
Master integrates workflow rules to ensure all complaints are processed
correctly. A side benefit of this workflow is the ability to filter
complaints based on the complaint status. Filtering complaints by
status allows mangers to divide the workload among several groups
of resources while at the same time maintaining complete visibility
on the overall process. For example, mangers can assign certain employees
to enter complaints, others to send acknowledgement letters, and yet
other to conduct evaluations and investigations. Managers can quickly
view how well the department is doing by monitoring the different
queues the system tracks.
The
following are a sample statuses tracked by Complaint Master:
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Acknowledge
(Waiting to be Acknowledged) |
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Investigate
(Waiting to be Investigated) |
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Approve
(Waiting for Approved) |
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Close
(Waiting for Closure) |
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On-Line Trends
Create
meaningful trends with a few mouse clicks and explore the complaint
data in a drill-down fashion from "general" to "specific".
The Run Charts and Pareto Charts displayed can quickly paint the "high
level" picture on where the complaints are accumulating. In addition,
when a trend is detected, users can easily explore the data by drilling
down on a product or issue by clicking the chart. Complaint Master
supports a four level product hierarchy, which means that users can
trend Product Groups, Product Lines, Assemblies and Components using
the On-Line Trend screen.
All
charts are customizable via the "Charts Properties Panel".
Users can configure the starting and ending month for a chart as
well as other useful options.
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Numerator-Denominator Charts
In addition
to the Run Charts and the Pareto Charts created by the On-Line Trends
panel, user can create trends on specific product issues by selecting
the product and the issue from a list of possible issues. These charts
are called Numerator Charts.
Complaint
Master can also create Numerator-Denominator Charts, also known
as Normalized Charts, by dividing the figures on
a Numerator Chart by a normalizing factor such as Sales/Month, Procedures/Month
or other normalizing values that are numeric.
To aid
users with the analysis of the complaint data, Complaint Master
can retrieve the complaint records shown on the trend chart by clicking
on the data points. Users can quickly determine if all complaints
are correctly coded and therefore ensure the reports are accurate.
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Monitor Trends
Complaint
Master makes it very easy for users to track only those trends that
are of interest to them. This personalized list of charts is automatically
updated with the latest trend data on a periodic basis. No longer
do employees have to wait for trend reports to be generated. And since
trend information is available close to real-time, the organization
can react faster and do a better job of anticipating problems when
a important trend is detected. |
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Report Wizard
Create
custom reports easily with the Report Wizard. Select fields, Sorting
Options, Filtering Criteria, Report Layout Format and the Report Wizard
creates presentation quality reports. The wizard is intuitive and
requires no programming skills.
Each
user creates their own personal list of custom reports. Reports
that are created by the Wizard can be saved and run periodically.
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Standard Reports
Complaint
Master includes a standard set of reports that cover a broad range
of report types. These reports offer parameter fields that the user
can modify to narrow the selection criteria of the query.
Some
of the Standard Reports Titles include:
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Complaints
with Adverse Events |
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Complaints
by Date Range |
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Complaints
by Text Search |
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Complaints
by Lot or Serial No. |
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Complaints
by Part No. |
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Export Data
Exporting
data to other systems is a simple process with the built-in data export
capabilities of Report Writer. Using the Report Writer tool users
can select the source data of a report and export it to several popular
output formats.
Some
of the output formats supported by the Report Writer Tool are:
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Microsoft
Excel |
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Microsoft
Access |
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Text
Delimited |
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HTML |
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Microsoft
Word |
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Complaint Views (by Customer)
Quickly
find complaints received from a customer while on the phone with them.
Using the Customer Directory panel (shown on the right) users can
locate a customer and then display their complaints. The image shown
on the right lists the customers on the left window and the complaints
on the right.
If more
detailed information on a complaint is needed, users can double
click the complaint item and retrieve all the complaint information.
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Adverse Event Forms
Complaint
Master supports the MedWatch, Vigilance and other regulatory forms.
If a form is needed that Complaint Master does not support, you can
easily create it using the Template features of the system. Complaint
Master supports exporting data from the system into the customized
form.
In addition
to the basic functionality for creating forms and exporting data,
Complaint Master allows advanced users to alter the behavior of
a form by using specialized macros written in VBA.
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Configurable Options
Complaint
Master has many features that can be configured by the user with the
proper administrative permissions. The configuration options offered
by the system give companies the ability to adapt the system to fit
their needs.
Some
of these configurable features include:
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Drop-down
list boxes |
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Templates |
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Security |
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Pre-written
Text (automatic text fill-in for large text fields) |
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Auto-Emails |
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Days
Open |
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To Do's List
The To
Do's panel will allow users to create quick reminders of things they
need to complete to process a complaint. Users can also assign To
Do's to other users and notify them via email in the event they do
not regularly use the system.
The
To Do's functionality is an excellent tool for ensuring tasks that
must be completed do not get missed. Both In-Progress and Completed
tasks are stored by the system, which helps users/managers audit
work done on a complaint.
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Event Log
There are
certain events that occur in a complaint that are important to capture,
such as when the customer is contacted to acknowledge the problem,
or when a complaint is re-opened. To help with this, Complaint Master
maintains an Event Log that records these events
as they occur during life of a complaint.
The
Event Log panel can also be used as a note posting tool to record
time-stamped notes of important facts about the complaint that can
be posted but not changed.
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Security
Managing
Security in Complaint Master is made easy via a role membership metaphor.
Administrators can configure the type of access users have by assigning
users to a role. Roles define what screens the user can access as
well as which fields they can modify or view. Complaint Master roles
can be customized to provide maximum configurability.
To protect
unauthorized access from the database or server end, password authentication
on the database server is strictly enforced.
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Corrective Action
Complaint
Master provides the option of creating a Corrective Action for a complaint.
The system provides several types of Corrective Action options to
choose from. For example, users can indicate that Future Monitoring
of the Trend is required or attach a Position Paper or Post information
into the companies Corrective Action system. |
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Pre-Written
TEXT
Pre-Written
TEXT is a productivity feature that saves users from typing long
paragraphs of text that are typed frequently. To use this feature,
users save the Text they wish to reuse in the Pre-Written TEXT panel.
To retrieve the Text, users select the desired paragraph from the
catalog with a few simple clicks. This feature saves typing time
and helps ensure the quality of the input.
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Days
Open
Complaint
Master provides a visual cue on how long a complaint has been open.
The cue is located on the main screen of the complaint form, and it
serves as a color coded reminder on how long a file has been open.
The configuration options are green (within department guidelines),
yellow (at risk), and red (overdue). The number of days for each color
is configurable based on the goals or policies of the department. |
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Same
Lots Complaints
All Serial
or Lot numbers that are entered with a complaint can be quickly checked
against all other Serial or Lot numbers entered in the system for
matches.
If any
matches are found, the system displays a list of these matches and
respective file numbers. From the list, users can retrieve the detailed
complaint information to determine if the Serial or Lot number is
in question.
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Audit
Trail
To comply
with 21 CFR Part 11, Complaint Master maintains a complete audit trail
of all the changes made to complaint records. Each entry is time-stamped
with the date and time the change was made as well as the name of
the employee who made the change.
The
Audit Inspection tool shows all the changes made to a record in
chronological order, visually marking those fields that were changed
in an entry.
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Multiple
Items per Complaint
Complaint
Master supports Multiple items per complaint. What this means is that
users can associate as many products as necessary with a complaint
record. This feature is very useful when a complaint involves for
example, a device that uses an accessory, and that accessory uses
a disposable item. With Complaint Master you can capture all product
items in one complaint and not loose the ability to trending
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Quick
Search
When entering
a new complaint, Complaint Master provides quick search capabilities
to locate and automatically populate customer or product information.
This feature increases user productivity and minimize data entry error. |
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Customizable
Codes
Complaint
Master supports three separate code categories to classify complaint
issues. These codes are entirely user configurable and are the basis
for creating trend charts and reports.
The
codes categories supported by Complaint Master are:
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Customer
Issue Codes (what the customer perceives the issue is) |
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Failure
Mode Codes (what the analysis showed the issue is) |
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Other
Codes (a miscellaneous category for additional codes) |
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Hierarchical
Product Catalog
Complaint
Master supports a hierarchical product catalog (i.e. a tree structure)
to represent products within the system. The advantage of using a
tree structure is that it contains more information than a flat list
and therefore enables the system to group products in families and
sub-groups that are natural and intuitive.
So for
example, if part no. B is a piece a larger product labeled part
no. A then the hierarchy would show B as a branch of A. When trending,
this information helps the system show how part no. B contributed
to the total number of issues found on part no. A.
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Performance
Complaint
Master was built from the ground up using the latest advances in client-server
architecture and software technologies that deliver the best performance
and scalability for a system of its kind.
Our
installations of Complaint Master in some cases span interconnected
sites across the US and Europe with excellent performance. Complaint
Master supports TCP-IP and is compatible to networks running Novell
or Microsoft NT/2000.
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Scalability
Scalability
of a business application is the easy with which a system can accommodate
an increasing number of users without degrading in performance. Scalable
systems will handle growth smoothly without a significant impact on
performance. Non-scalable systems, by contrast, will quickly reach
an upper limit of users it can support after which performance degrades
dramatically.
Complaint
Master was built using software architecture principles based on
the Internet Stateless model, which is one of the most scalable
software architecture models available today.
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