Compliance Inspection Management System (CIMS)

AutoSoft Systems

2 Round Hill Court

East Greenwich, RI 02818

401.885.3631

401.884.5653 Fax

401.996.3631 Cell

AMDG

Decision Ready Information!

autosoft@aol.com

Commercial & custom multi-user computer software for a variety of applications including performance metrics, statistical analysis, data extraction and merger from multiple large databases, computer simulation and management information systems. Founded in 1982.

We know Excel! Whenever possible, Excel is the user interface, VBA is the programming language, ODBC connects to the database of your choice.

Pharmaceutical & Biotech

Construction Management

AMDG

Compliance Inspection Management System (CIMS)

All pharmaceutical, food and chemical manufacturing facilities are subject to inspections by regulatory agencies
(FDA, EPA,….). The CIMS tool provides a framework for managing these inspections.

For more information or to schedule a demo, please contact Joe Serdakowski

Technical Features & Associated Benefits of CIMS

Features

Benefits

• Multi-User Excel 2010 front end

• Nothing to install on users machines, easy to learn

• Multiple user types

• Control "who does what" in the program

• VBA source code available

• Easy to customize

• Password protected

• Program protected from unauthorized changes

• Microsoft Access Database (standard)

• Industry standard

• Automatic hourly backups

• Minimal or no loss of data in case of hardware failure

• SQL Server or Oracle Database (optional)

• If so required by corporate IT policy

• Custom Ribbon

• Limits users to only allowed functions

• Context sensitive Help

• Guides users as required

• Complete Change Log

• Can fully trace ever change to data, who, what, when

• Production & Test Instances

• Use Test Instance for training, clear indication that Test is in use

• Consistent User Interface

• Rapid user learning curve

Customizing the Excel Ribbon

Excel switched from a standard menu to the "Ribbon" starting with Excel 2007. This has given VBA programmers like Dr. Serdakowski tremendous flexibility in the design of custom Excel applications. The following illustrates the ribbon options on the Main screen depending upon whom has the program open:

Programmer:

SuperUser:

Viewer:

CIMS Process Flow

Program setup and configuration

• Import Resource list. CIMS can accept any standard export from any ERP or Payroll system (e.g. PeopleSoft, SAP,….)

• Import Product list. A simple Excel file with a list of the products manufactured at the facility.

• Import Document Type list. A large component of any inspection is the supply of requested documents. A simple Excel file with a list of the document types is imported. (e.g. SOP, Batch Record, Form,….)

• Assign roles in the program. There are several roles that exist. One resource can wear as many "hats" as appropriate.

• SuperUsers - total program control

• Inspection Leads

• Scribes

• RMT (Response Management Team) Leads

• Doc (Documents) Leads

Managing the Inspection - What to do when there is a "knock on the door":

• SuperUser creates a new inspection, records "Header" information:

• Inspection Agency

• Start Date

• Inspection Year

• Inspection Type

• SuperUser assigns the "roster" for this inspection based on qualified resources identified in the program setup:

• Name of the Inspector(s)

• Inspection Lead(s)

Illustration of the screen used to manage resource lists

• Scribe(s)

• RMT Lead(s)

• Documents Lead(s)

• Viewer(s)

Everything starts at the Main screen:

Fully configured Header screen:

Inspection Room Lead Minutes Screen:

• Inspection Lead or Scribe enters Minutes on the Inspection Lead Minutes Screen

(If multiple Inspection Leads specified, each one has his/her own screen)

Request List Screen:

• Inspection Lead(s) or Scribe(s) simultaneously enter Requests on the Request List Screen:

Response Screen:

• Authorized users can enter responses to each request on the Response screen:

RMT (Response Management Team) Screen:

• The RMT (Response Management Team) can add SMEs (Subject Matter Experts) and Documents on the RMT screen:

Documents Screen:

• The current status of all requested documents is summarized on the Documents screen:

Note: This simple example shows only 3 documents and 3 requests. CIMS can easily handle hundreds of documents and requests, typical in a comprehensive inspection.