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Calibration Software:
The Buck Starts at
User Requirements
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Calibration Software: The Buck Starts at User Requirements
The FDAs Medical Device Quality System Regulation, section 7, specifes (both explicitly and implicitly) that calibration
and maintenance will be continuously required based on the risk factors recommended by machine manufacturers and
by the users experience with the machinery itself. GLP and drug related GMPs also require the continued practice of
calibration and maintenance as do ISO quality requirements. In short, one thing is clear: calibration and maintenance are a
crucial part of the quality control foundation that leads to regulated compliance and high-caliber products:
The Benefts of Streamlined Calibration Processes
Complying with calibration requirements is often best accomplished with calibration software, the use of which will likely
result in the following benefts for life science, engineering and additional high-tech organizations:
Helps to ensure machinery continuously operates within the parameters necessary to produce a product that meets
specifcations
Saves companies hard earned revenue by decreasing the amount of products that have to be recalled.
Helps to evaluate the value (i.e.ROI) of machinery.
Records and tracks appropriate calibration/maintenance records and documents for utilization during audits (both
internal and external).
Allows for automatic scheduling of calibration tasks.
Allows users to easily check the status of a calibration task.
In short, its obvious that calibration software can be one of the most valuable purchases that operations personnel can
invest in, but the elusive CMS (calibration management software) isnt an easy product to shop for. A simple online search
for calibration software for instance can result in a bedazzling array of features, benefts and buzzwords leaving even
the most experienced operations personnel with little desire for investigation.
The Right First Step: Dont Shop Backwards
Many operations personnel will begin their search for calibration software by doing a search online or by asking a trusted
co-worker his or her opinion regarding a particular solution. Though these methods may prove valuable, they are a form
of backwards shopping and only extend the hunting (or gathering) process. The right frst step is simply to determine
what and why the calibration software is needed, record those needs and then contact various calibration software
providers with documented user requirement specifcations.
Important Considerations for User Requirement Specifcations
The following recommendations may be useful for those interested in creating a list of user requirement specifcations:
Express each requirement in 200 words or less. 1.
Express requirements only once. Avoid unnecessary duplication. 2.
Instead of suggesting solutions to the calibration software creator, simply specify needs. (If a company cant meet 3.
those needs, then move on to the next one).
Make sure that requirements can be tested and that the potential for clear testing conclusions is evident. 4.

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Calibration Software: The Buck Starts at User Requirements
Express each requirement clearly so that both the writer (the potential buyer) and the reader (the supplier) can 5.
conceivably understand the written requirements without diffculty.
Clearly designate whether a desired feature or beneft 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 respective 7.
supplier.
Follow the recommendations listed above as far as they prove useful but keep in mind that an initial draft of user
requirement specifcations need not be anything stringently formal. A simple list of needs and wants will suffce. To learn
more about user requirement specifcations for calibration software solutions, please refer to the following potential user
requirement specifcations.
Some User Requirement Specifcations
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 specifcations, are listed as
follows:
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 notifcations depend on Joe (who
is out to lunch) instead of on electronic systems (which rarely rest) trouble is on the horizon.
User Requirement Specifcation 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 diffculty.
Problem #2: Inaccurate Tracking and Lack of Effective Analytics
When paper-based or hybrid systems of calibration are implemented its diffcult to keep track of calibration forms,
documents, and assignment status from start to fnish.
User Requirement Specifcation for Calibration Software #2
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.
User Requirement Specifcation for Calibration Software #3
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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Calibration 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 magnifed since the duties of operations personnel are likely
to 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.
User Requirement Specifcation for Calibration Software #4
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 Specifcation for Calibration Software #5
A 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.
User Requirement Specifcation for Calibration Software #6
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 dissatisfed, especially when company
policies or procedures change and the calibration software remains infexible to new developments.
User Requirement Specifcation for Calibration Software #7
A user with problem #7 will require a calibration software solution that is fexible 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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Calibration Software: The Buck Starts at User Requirements
User Requirement Specifcation for Calibration Software #8
A user with problem #8 will specify that he is in need of a calibration software solution that implements high-level
security and maintains that security along pre-approved routing paths (for documents) and throughout chains of
approval.
User Requirement Specifcation for Calibration Software #8
A user with problem #8 will specify that he is in need of a calibration software solution that implements high-level
security and maintains that security along pre-approved routing paths (for documents) and throughout chains of
approval.
Conclusion
These user requirement specifcations for calibration software are only some of the possible user requirements that life
science and high-tech professionals might fnd necessary for their unique professional purposes. Professionals may also
fnd that their own list of additional user requirement specifcations is easily composed once an awareness of problems
and/or concerns associated with calibration have been raised.
http://www.fda-compliant.net/user-requirement-specifcation.html
About MasterControl Inc.
MasterControl produces software solutions that enable regulated companies to get their products to market faster,
while reducing overall costs and increasing internal effciency. MasterControl securely manages a companys critical
information throughout the entire product lifecycle. Our software is known for being easy to implement, easy to validate
and easy to use. MasterControl QMS and QEM solutions include quality management, document management/document
control, product lifecycle management, audit management, training management, bill of materials, supplier management,
submissions management, and more. Supported by a comprehensive array of services based on industry best practices,
MasterControl provides our customers with a complete information management solution across the entire enterprise. For
more information about MasterControl, visit www.mastercontrol.com, or call: 1.800.825.9117 (U.S.); +44 (0) 1256 325
949 (Europe); or +81 (03) 6801 6147 (Japan).
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