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Given the evolution of quality
systems, the science of measurement and the constant drive
for increased productivity, selecting calibration software
can be challenging to say the least. Companies whose livelihoods
depend upon it must choose an excellent system. Variables
in the process are numerous and don't necessarily contribute
to straightforward decision making. The criteria for evaluating
and selecting calibration software fall into four primary
categories: quality system compliance, laboratory requirements,
system requirements and budget. Each category can significantly
affect the others, so any software selection must be weighed
and balanced for optimum system performance. Let's take
a closer look at each category.
The principal driving force behind calibration software
is compliance to quality standards. During the past 20 years,
the metrology industry has had to comply with myriad standards,
beginning with MIL-STD-45662A and continuing with ANSI/NCSL
Z-540, 10 CFR 50 Appendix B, ISO 9001, ISO/IEC Guide 25
and ISO/IEC 17025, among others. As global economics have
evolved, so have international standards.
Calibration software should be designed to help maintain
the highest quality levels--however they're defined. The
system must consistently meet calibration, technical and
quality requirements while also providing adequate controls
over laboratory processes. Calibration software must properly
address the following key aspects:
Protecting confidential information
Controlling calibration documents
Maintaining approved supplier lists
Documenting complaints and corrective and preventive action
Controlling and securing data records
Validating methods for calibration or testing
Documenting estimated measurement uncertainty
Controlling and maintaining measurement and test equipment
Documenting measurement traceability
Ensuring the quality of test and calibration results
Creating and maintaining test reports and calibration certificates
Providing laboratory and equipment status reports
Ensuring that quality requirements are met is the critical
first step in selecting calibration software. The software
must be capable of thoroughly recording the calibration
process and data with absolute integrity and assurance.
If it fails to meet specified quality requirements, the
laboratory itself risks failing critical quality, certification
or accreditation audits.
Although calibration lab requirements vary based upon
an organization's size and type, two types of calibration
laboratories predominate: in-house and commercial. In-house
labs typically support internal calibration needs. Commercial
or third-party labs offer their services to a broad spectrum
of industries. Both share the same quality requirements
and productivity needs.
Today's calibration laboratories require dedicated, comprehensive
calibration software systems to effectively manage their
processes. In the quest for a comprehensive calibration
system, it's important to identify the key criteria that
your laboratory requires. Every quality system has certain
unique requirements it must satisfy, and identifying these
requirements during the initial selection process will save
both time and effort.
Although most calibration systems offer the same basic
features and functions, you should thoroughly evaluate the
following areas to determine their applicability for your
needs:
System design and architecture that meet overall quality
and laboratory requirements
Security system designed to preserve the integrity of confidential
electronic records
Uncomplicated user interface to allow quick and easy access
to desired information
Complete set of tools to manage the calibration process,
from initial order to completion
Data organization designed for minimal data entry and maximum
throughput
Production of complete and correct calibration documents
Documentation of measurement uncertainty results
Production of laboratory management and productivity reports
Ability to electronically transmit reports and data via
e-mail or other methods
Flexibility for customizing field names to complement existing
laboratory terminology
Advanced filters to quickly find records that match desired
criteria
Documented system validation and verification protocol
In addition, the calibration software must help your company
remain viable and profitable in the marketplace by meeting
customer expectations and increasing productivity with minimum
personnel. Careful consideration should be given to satisfying
the needs of clients, management, administration, metrologists
and quality personnel.
Measuring and test equipment users need to know that their
equipment has been properly calibrated, as evidenced by
calibration documents. Therefore, the calibration software
should produce complete and correct calibration certificates,
reports and labels. Errors in calibration documents cause
unnecessary delays and corrective action. One method of
reducing errors is implementing predefined "pick lists."
Systems that incorporate these user-defined lists can prevent
operator errors while increasing data-entry efficiency.
An effective calibration system will help minimize errors
and, in turn, raise productivity.
Turnaround time is affected by many variables, some of
which are beyond the laboratory's control. However, an effective
calibration software system will track and monitor the status
of each item in process to minimize backlog and reduce turnaround
time. Management tools designed to track productivity are
invaluable resources for monitoring lab and personnel performance.
The lab's work tempo must be under constant surveillance
to ensure quick turnaround time and high productivity and
to prevent potential problems from slipping through the
cracks.
Security is of utmost concern to management and quality
personnel. Electronic records are an ever-increasing part
of our society and an integral part of the calibration process.
The system must incorporate a comprehensive security scheme
to safeguard data and limit system access to authorized
users only. Various levels of permission must be granted
for individual users within the system. Login rules further
define user access in terms of number of login attempts
and automatic user inactivity logouts. Automatic, computer-generated,
time-stamped audit trails should be used to independently
record the date and time of operator actions that create,
modify or delete records within the system. Calibration
records should be signed and time- and date-stamped by authorized
individuals. Authority checks further ensure that only authorized
individuals can log into the closed system.
Security is an even greater concern for facilities that
must comply with the FDA Title 21 Code of Federal Regulations
concerning electronic records. According to this regulation,
electronic signatures are an integral requirement for securing
electronic records and limiting system access. Key elements
of a closed calibration system that complies with 21 CFR
Part 11 include:
Authenticity, integrity and confidentiality of electronic
records
System validation to ensure accuracy and reliability
Ability to distinguish invalid or altered records
Ability to generate accurate and complete copies of records
Protection of records for accurate retrieval throughout
the retention period
Limited system access to authorized users only
Computer-generated, time-stamped audit trails to record
operator transactions
Authority checks to ensure use by authorized personnel
Maintenance of system development and modification documents
Calibration software systems that properly comply with
21 CFR Part 11 yield significant advantages. The records
these systems maintain are considered trustworthy, reliable
and generally equivalent to their respective paper records.
Furthermore, electronic records that meet the requirements
of 21 CFR Part 11 may be used in lieu of paper records,
unless they're required or preferred by the recipient.
Calibration procedures and calibration data collection
are important aspects of any calibration software system,
and laboratory productivity and profitability are directly
related to it. Huge amounts of data are gathered and processed
for every calibration. Data from the client, asset, work
order, calibration, standards, labor and parts must all
be complete and correct.
Minimizing data entry is one way to reduce or eliminate
transcription errors while increasing productivity and customer
satisfaction. Automatic pull-down menus speed data entry,
reduce errors and eliminate erroneous entries. Additional
automatic data entry for system- or client-default information
further enhances and increases each transaction's speed.
Finally, an efficient software system should incorporate
a comprehensive method of generating calibration procedures
for collecting "as found" and "as left"
calibration data. Effective calibration software should
be intuitive, streamlining and automating as many processes
as possible.
Laboratory size, number of locations, users and assets
will determine the type and configuration of the calibration
management system. Dedicated calibration management systems
typically address three types of users: the small user with
a single workstation or small network, the medium-to-large
calibration laboratory whose requirements can extend to
multiple facilities, and labs that require the flexibility
of in-lab and off-site mobility. The primary differences
among these systems are the system architecture, database
engine, development language, and available features and
functions of the software.
For small users, common database engines are Microsoft
Access, dBase, Paradox and FoxPro. These offer a low-cost
solution for a single workstation and can be locally networked
with a limited number of users. However, performance issues
may arise when the number of records exceeds 10,000. These
systems are typically adequate for laboratories on a limited
budget.
Medium to large calibration laboratories are best served
through an SQL database engine. There are several to choose
from, but the most popular is Microsoft SQL Server 2000,
which offers a highly scaleable enterprise database solution.
It can be used in a client/server or n-tier application
and is the preferred database engine for most calibration
software systems. An SQL database system also provides the
backbone for future Web interfaces.
Other SQL database engines include Oracle, DB2 and Sybase.
Check with the calibration software provider to determine
which database engine is recommended and what software licenses
you'll need.
Other considerations include the requirement for off-site
calibration work. In this case, your calibration software
must have the capability to be used both in the laboratory
and remotely, either on a notebook PC or PDA device. The
system should replicate the data, a process that duplicates
and transfers required data between the mobile device and
server.
If you're upgrading from another system, you'll need to
address how to migrate your current data into the new system.
Fortunately, data migration into most SQL databases is
straight-forward. However, difficulties can arise in extracting
the data from older systems or filtering out bad data.
When preparing a budget for purchasing calibration software,
consider your quality and lab requirements, your type of
laboratory, the number of locations, users and the type
of calibration work you perform. You'll also have to budget
for installing the system, training personnel, receiving
software support and migrating legacy data, if applicable.
Quality calibration software that's designed to meet ISO/IEC
17025 and 21 CFR Part 11 will vary in price and performance.
This type of calibration software has been designed and
tested to the most rigorous requirements in the metrology
industry. Your job is to evaluate how well the system actually
meets the quality requirements and your specific laboratory
needs. In most cases you'll find the software is worth every
penny and will most likely save you money.
Once you've narrowed your search and determined the total
cost of the calibration software system, you can perform
a cost-benefit analysis to determine your actual time savings.
The primary goal when evaluating and selecting calibration
software is satisfying quality requirements. A system that
can't comply with regulatory requirements isn't a bargain
at any price. Next, evaluate the system to determine not
only what it does but also how it does it. You'll find that
many calibration software systems perform similar tasks,
although their methods can differ substantially. The program's
flow, data formatting and population significantly impact
how well your team will function and perform with the new
system. You shouldn't have to change your operating procedures
to fit the software, and the software shouldn't force you
to do more work than required. Look for a complete solution
to your needs. A system that's powerful and robust, yet
still provides flexibility, will increase your company's
productivity and improve quality.
Kim Rosenstein is currently a technical trainer and road
warrior for Cybermetrics Corp. in Scottsdale, Arizona. She
has spent 70 percent of her time this year conducting training
classes at client locations. Ditloff has degrees in English
and information technology. She has worked as a teacher,
technical writer, programmer and systems analyst. Letters
to the editor regarding this article can be sent to letters@qualitydigest.com
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