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COMPLIANCE ACCELERATED

White Paper:Calibration Software:The Buck Starts atUser Requirements


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White PaperCOMPLIANCE ACCELERATED

libration Software: The Buck Starts at User Requirements

Express each requirement clearly so that both the writer (the potential buyer) and the reader (the supplier) can5.

conceivably understand the written requirements without difculty.

Clearly designate whether a desired feature or benet is a need (must have) or a want (would like to have).6.

Include a requirement for a live review. The live review should occur between the potential buyer and the respective7.

supplier.

Follow the recommendations listed above as far as they prove useful but keep in mind that an initial draft of user

requirement specications need not be anything stringently formal. A simple list of needs and wants will sufce. To learn

more about user requirement specications for calibration software solutions, please refer to the following potential user

requirement specications.

Some User Requirement Specications

Some problems experienced by those life science or technology companies currently using a manual or hybrid calibration

management system and their respective (and subsequent) hypothetical user requirement specications, are listed asfollows:

Problem #1: Manual Processes

Problems related to calibration management that life science or technology companies may commonly experience are

the slow processes of data collection and transfer that correspond with paper-based management techniques. Paper-

based forms for example are liable to get lost or misplaced, and when calibration notications depend on Joe (who

is out to lunch) instead of on electronic systems (which rarely rest) trouble is on the horizon.

User Requirement Specication for Calibration Software #1

A user experiencing problem #1 will often require that the software solution manage calibration documentation

seamlessly. This means that calibration records should be electronically created, managed, archived and retrieved

without difculty.

Problem #2: Inaccurate Tracking and Lack of Effective Analytics

When paper-based or hybrid systems of calibration are implemented its difcult to keep track of calibration forms,

documents, and assignment status from start to nish.


A user with problem #2 will specify that he needs a calibration software solution that tracks forms and documents

electronically while simultaneously providing version control (only the most recent versions are available for edits).

This software solution should also provide analytics and reporting features so that uncompleted tasks can be escalated

to appropriate levels.

Problem #3: Lack of the Appropriate Employee Training

A major problem related to calibration processes is the incomplete, ineffective or nonexistent training of employees

with responsibilities related to calibration.


A user with problem #3 should search for a calibration software solution that will not allow the launch of a calibration

form if an assigned employee has not received the appropriate training.


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White PaperCOMPLIANCE ACCELERATED

libration Software: The Buck Starts at User Requirements

Problem #4: Scheduling Practices

A common calibration problem for life science and technology companies is calibration scheduling. Regular

calibrations are required but often neglected when subject to manual or hybrid processes. For those machines that are

calibrated less often, the problem can become even more magnied since the duties of operations personnel are likelyto be extensive and its easy to neglect the fact that that one part of one machine needs to be calibrated during the

second week of September next year.


A user with problem #4 will likely require calibration software solution that will notify operations personnel (via

email for example) of any upcoming or present calibration processes that need to be under way.

Problem #5: Lack of Connectivity with External Data Sources

Another reoccurring problem for life science and high-tech companies is the lack of connectivity between calibration

maintenance applications and external data sources.

User Requirement Specication for Calibration Software #5A user with problem #5 should search for a calibration software solution that will allow users to access equipment

asset information, vendor information and additional information from an ERP or additional external data sources.

A calibration solution for instance may---via an electronic form---offer external data selection options within a drop

down menu. With the simple selection of an option, relevant data is automatically populated within the calibration

form.

Problem #6: Transcription Errors

Since calibration processes are inevitably connected with maintenance processes, it is common for calibration data to

be transferred from calibration forms to maintenance forms. In the past however, this transferor transcriptionof

data from one from to another has traditionally been managed manually, or with hybrid systems, that require tedious

data entry from one form to another. Both manual and hybrid systems waste time and lead to a variety of transcription

errors.


A user with problem #6 will specify that he needs a calibration software solution that automatically populates

data from calibration forms to those required for maintenance. The auto-population of data saves time and greatly

decreases the amount of transcription errors that occur during form-to-form data transfers.

Problem #7: Lack of Flexibility

Some users will actually purchase a calibration software solution and still be dissatised, especially when company

policies or procedures change and the calibration software remains inexible to new developments.

User Requirement Specication for Calibration Software #7A user with problem #7 will require a calibration software solution that is exible for future integration with

additional products, and adjustable to new company policies or procedures.

Problem #8: Lackadaisical Security

Calibration system security can be far from desirable when paper-based or hybrid systems are implemented for

management purposes.


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