BenchTop™ FAQ/BenchTop Sales

Answers

Section 1:   Technical Requirements 

1. Which programming language is used?

BenchTop™ is written in a PowerBuilder language.  Sybase Manufactures PowerBuilder.

2. How will source code be made available?

Provisioning of BenchTop™ Source Code can be made available.  Source Code will only be extended to customers holding an unlimited site license to a single database.  (See Price Guide).

3. Which hardware platform do you support?

BenchTop™ currently supports the alpha or Intel based hardware platforms.  Must be Microsoft compatible?

4. On which databases do you run?

BenchTop™ runs on Sybase & Microsoft SQL, version 7.0 and 2000.

5. How is the link to the Internet organized?  Does the system support direct quires from a website database engine for reporting equipment status to customers?

Yes, through Active Server Pages and ODBC.

6. Which protocols do you support?

TCP/IP and NetBeui.

7. What data is held on the client?

There is no data held on the client workstation.  All data is held on the server level.

8. Does the BenchTop™ client run on Windows 95/98/NT and 2000 operating systems?

Yes.

9. How does the user’s workstation communicate with the main database?

Microsoft SQL Client Connectivity (DBMS).

10. What operating system do you recommend for the Client Workstation?

95/98/NT/2000.

11. Can the BenchTop™ system run on one server?

Yes, we recommend that the BenchTop™ database reside on a single server and that that server is strictly used for BenchTop™.

Section 2:  Regulatory Requirements   [ top]

Answers

1. Is your system compliant to ANSI/ISO/IEC 17025:2000?

Yes.

2. Is your system compliant to Food and Drug Administration Quality System Regulation 21 CFR Part 820 Medical Devices; Current Good Manufacturing Practice; Final Rule?

Yes.

3. Is your system compliant to FDA Title 21 Code of Federal Regulations (21 CFR Part 11) Electronic Records; Electronic Signatures; March 2000?

BenchTop™ meets most of the requirements of FDA 21 CFR 11, with the exception of audit trails.  The current BenchTop™ version (3.5) has audit trail capability but does not include an audit trail for all transactions.

4. How do you support the validation of your software?

If requested, BenchTop will supply the customer with software test cases and test logs.

5. How will you support future revisions of regulatory documents?

BenchTop and CMI intends to support all regulatory agency requirements.

6. How does your system handle data validation?

BenchTop Software implements a rigorous function and data validation test suite using test cases and test logs.

Section 3:  Calibration Workflow   [ top]

Answers

1.      How does your system support automatic calibration interval adjustment? Will the system use the last calibration data results to activate a new calibration interval to be reflected in the printed out calibration label? 

            Yes, if the Cal Date field is blank when the cursor enters that field, BenchTop™ will automatically enter the current date and compute the Cal Due date based on the calibration cycle in the Equipment Record (end of week, end of month or none).  If the calibration date needs to be changed, a popup calendar can be used.  The Cal Due Date is automatically computed based on the cal interval assigned in the Equipment Record, with any adjustments requested in the Customer Folder.  Dates may be adjusted to the end of a week, or end of a month.  You are not allowed to enter a cal date that is later that the cal due date; conversely, you are not allowed to enter a cal due date that is earlier than the cal due date.

2. Does your system support multiple scheduled maintenance services for each asset?

BenchTop supports calibration Recall dates.

3. Does your system automatically update due dates for preventative maintenance actions and other non-calibration services?

BenchTop does not include preventative maintenance schedules.

4. Does your system accommodate forward and reverse traceability with error checking?

Yes.  BenchTop provides forward and reverse traceability.

5. Does your system accommodate individual time accounting entries?

Yes.

6. How does your system handle on-line access to calibration and maintenance procedures?

BenchTop provides reference to calibration procedures as a component of the TMDE record.

7. What is the limit of your open-ended history notes?

BenchTop notes fields provide for 255 bytes of information.

8. How does your system ensure that the current revision calibration procedure is being used?

Calibration procedure revisions are updated in the CalForm module.  The system inspects the revision number and makes the operator aware if they are using a prior version.

9. How does your system handle out-of-tolerance and non-conformance reporting and tracking?

BenchTop utilizes two separate tools that are capable of reporting OOT.  They are the OOT – Outstanding and OOT – Notification.

OOT – Outstanding: 

The OOT-Outstanding Application is a method of tracking notifications that have been sent to customers.  These notifications were initiated in the Lab Folder and remain outstanding until they are completed and returned to the laboratory.  The notices can be printed in the Lab application as well.  Out of Tolerances that are closed drop off the Outstanding Out of Tolerance Notification screen.  Out of tolerances are closed via the work order, which can be accessed in the Lab Folder, or this application. 

OOT – Notification:

The Out of Tolerance (OOT) Notification window allows you to call up any previous notification.  Although the window is currently assigned to the Quality Review application, you may want to assign it to the Document Viewer application as well.

OOT Notifications are retrieved from the Query window in the same manner as other documents.  Select a Work order and click OK to display the OOT Notification.

10. How does your system handle bar codes and customized labels?

BenchTop provides bar code capability as an option.  Labels may be customized through the use of a morphor attached to an Eltron printer.

11. What method is used to track and maintain equipment location?

Status Tracking provides online, real-time status information essential to providing quick answers to customer inquiries.  Additionally, online status tracking helps manage workflow by providing instant status information.  A complete status history is available as well, providing information long after the equipment has left the lab or your facility.

The Status Tracking window is divided into two panels:  SalesOrder (top) and WorkOrder (bottom). 

SalesOrder Panel

In the SalesOrder panel, a search allows you to query on administrative data such as PO#, Acct#, and so on.

WorkOrder Panel

In the WorkOrder panel, a search allows you to query on instrument data, such as instrument ID, Serial Number and so on.

12. Can their be data fields available for client access, read and write?

Yes there can, both read and write as well as pick lists.  Currently, BenchTop™ contains 19 separate tables, which allow for read or write capability or a combination of the two.  They are:

Accessories – 7 descriptions

As-Found Conditions – 5 descriptions

As-Left Conditions – 6 descriptions

Contact Types – 11 descriptions

Customer Quality Requirements – 9 descriptions

Customer Source – 8 descriptions

Customer Type – 5 descriptions

Employees - Unlimited

Lab Departments – 9 descriptions

Lab Services – 28 descriptions

Measurement Capabilities – 92 descriptions

PO Pick List – 5 descriptions

Priority – 5 descriptions

Qualification Status – 4 descriptions

Reason for Service – 6 descriptions

Shipping Modes – 52 descriptions

States

Status Codes – 12 descriptions

Type of Calibration – 9 descriptions

Customers can individualize to their own needs, all data fields and picklists.

The data for all picklists are located in Table Manager.  The primary purpose of Table Manager is to provide maintenance services - adding, editing, and deleting records - for picklist tables used throughout the many windows in BenchTop™.  And because picklists are created in a relational database, that means even though each entry in a picklist table is created only once, it can be reused over and over in the same picklist throughout the system.  Picklists provide the benefit of faster data entry, fewer data entry errors and a high degree of consistency in the historical data.

13. How does the system accommodate repair actions?

BenchTop accommodates repair actions through a Maintenance Form within the Lab Folder.

The Maintenance Form is used to record repair and maintenance actions required to make the instrument serviceable.  Since this is a permanent record, you can always review previous maintenance actions regarding the instrument.

If an instrument is returned to the owner without being calibrated, this form may accompany the instrument in lieu of a Certificate of Calibration.  BenchTop requires that either a Certificate or a Maintenance Record be finished before the WorkOrder can be completed. 

14. How is “as found” and “as left” measurement data handled?

Within the Lab Folder in BenchTop, the DataSheet Form is used to record calibration measurement results.  The DataSheet template library, or CalForm library, is created and maintained in the CalForm Application.  If the WorkOrder Form indicates that data is required, this DataSheet will print on the Certificate of Calibration. 

InTolerance Conditions

The In tolerance conditions are automatically generated in BenchTop by comparing the results you enter to the Minimum and Maximum values on the template.  If the value entered is in tolerance, a blue a appears in the In? column.  If the value entered is out of tolerance, a red r appears in the In? column.  Values other than numerics may be entered in the As Found/As Left columns.  For instance, “Inop”, “Unstable”, “Left as Found.”  Putting characters in these fields disables tolerance checking.  However, the conditions may be entered manually by double-clicking in the In? column to toggle the condition between a, r , and blank.

15. Can “Certificates of Calibration” be printed out automatically upon completion of a calibration action?

Yes, as well as calibration labels.

Once the Certificate Form is complete, the lab technician is free to print the Certificate of Calibration.  This option is not available until the Certificate Form is complete.

Use Print Label with special BenchTop add-on printer.  If you have a BenchTop label printer in your system, use this option to print the calibration label.  This option is not available until the Certificate Form is complete.

16. Can technicians be assigned to user-defined groups for segregated work schedule, work flow, and work report tracking?

Yes.  Limitless work groups.

17.  How are unique equipment numbers defined?  Can there be different categories of equipment numbers?

BenchTop assigns internal unique numbers to all equipment.

18.  Can calibration procedure cross-index be defined that tracks equipment model numbers supported by a specific calibration procedure number?

Yes, by CalForm

19.  How are calibration recall intervals accommodated?

BenchTop accommodates calibration recall intervals, they can be modified using TMDE or Lab records.

20.  How are “parent” and “child” association of equipment supported?

Equipment is assigned by customer/department.  Equipment records are associated with a TMDE which is a library placeholder for the cal form, cal procedure and price code.

21. How are special flags and alerts accommodated?

Special Flags are accommodated through the use of notes and data validity checks.

22. Can the system manage the logging of environmental conditions during calibration actions?  Does this information automatically transfer into a certification report?

Temperature / Humidity

You have the option of scrolling through a drop-down temperature and humidity list, or manually entering the environmental conditions.  Note, if you enter a temperature or humidity reading that is outside of normal parameters, you will receive a warning.  You may not continue entering data to the Lab Cert Form until the temperature and humidity have been compiled.

Once this information is entered, the temperature and humidity is automatically transferred to the Certificate of Calibration for Report Printing.

23. How does the system validate calibration status of standards used?

BenchTop will alert the technician if a calibration standard is past-due for calibration.

24. Can the system provide for the assignment of default calibration intervals to unique types of instruments (same models)?

Yes, this is accomplished through the TMDE.

Section 4:  Management Functions  [ top]

Answers

1. Does the system have a user-friendly, menu-driven, report generator that is fully integrated witht the database?  If not, how are ad hoc reports generated?

BenchTop offers the InfoMaker report writer as an option for writing ad hoc reports.

2. Can reports be generated and distributed to a screen, a file, a printer, an e-mail address, and Internet media?

Yes, All of the above:  screen, file, printer, e-mail and Internet media.

3. How does your system accommodate maintaining and tracking of individual training proficiency and records?

BenchTop provides for the maintenance and tracking of individual training and proficiency and records through the Training Folder.  This fully integrated BenchTop tool contains two parts:  The Employee Qualifications area and the Qualifications Master List.

The Employee Qualifications window is a list of all active and inactive employees in the laboratory.  The list includes the names of employees, measurement areas, and measurement parameters that are within that measurement area.  The list also includes the date the technician was qualified and the status. 

The Qualifications Master List provides training and qualification information essential to managing the technical competence of a calibration laboratory.  A common quality inspection finding is to discover that an employee lacked documented qualifications for a particular calibration; or perhaps the training expiration date of the training was overlooked.  The Qualifications Master List is an excellent tool for evaluating, planning, and assuring the accuracy of training records.

4.      How are services tracked that do not apply to a specific item?

BenchTop has the capacity to add additional tasks performed by technicians or support personnel.

5.  How is labor tracked?

Labor is tracked through the time reporting function of the LAB module.