Back to Complaint Master

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:

When the complaint record is created
When the investigation is assigned
When the investigation is completed
When a complaint record is closed
When an Adverse Event form is created
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:

Acknowledgement Letter
Results Letter
General Memo to File
MedWatch Form
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:

Lotus cc:Mail
Lotus Notes
Microsoft Exchange
Microsoft MAPI
VINES
Internet Mail (SMTP/POP)
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:

Acknowledge (Waiting to be Acknowledged)
Investigate (Waiting to be Investigated)
Approve (Waiting for Approved)
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:

Complaints with Adverse Events
Complaints by Date Range
Complaints by Text Search
Complaints by Lot or Serial No.
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:

Microsoft Excel
Microsoft Access
Text Delimited
HTML
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:

Drop-down list boxes
Templates
Security
Pre-written Text (automatic text fill-in for large text fields)
Auto-Emails
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.


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 on all products separately.

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.

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:

Customer Issue Codes (what the customer perceives the issue is)
Failure Mode Codes (what the analysis showed the issue is)
Other Codes (a miscellaneous category for additional codes)

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.


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.


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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