Introduction

Today, Quality Managers and Operations Supervisors face increasing pressures to improve
compliance management practices. This becomes an even greater challenge when confronted with
tightening budget constraints. To remain competitive, the culture within many organizations is towards
technical applications that can improve efficiencies and help them to do more in less time and with
less effort.

When it comes to managing instrument calibrations and system qualifications, ProCalV5 offers unique
advantages. Whether for a single department or an entire enterprise, your workflow and oversight
practices can be automated, systematized and improved.

For FDA, ISO and other quality regulated facilities, migration to paperless operations
has become the proven strategy to achieve cost savings, ensure regulatory
compliance, and build a strong foundation for continuous improvement.

Industries Served
• Pharmaceutical &
Bio-Pharma Production
• All Process Industries
• Water & Waste Water
Treatment
• Gas Production and
Custody Transfer
• Chemical Production &
Processing
• R&D, Test and Metrology
Laboratories
• Instrument Service
Companies
• Nuclear & Power
Generation
• Petroleum and
Petro-Chemical
Production

Prime Technologies, Inc

ProCalV5 Calibration Software
ProCalV5
ProCalV5 was developed by a team of calibration
professionals who wanted a program that would
finally give them what calibration professionals need:
more power and functionality, more speed, and
easier set-up and operation. Through the guidance of
these professionals, ProCalV5 has become the most
powerful, most intuitively easy-to-use calibration
program available.

Performance and
Productivity with Paperless
Calibrations

• A Paperless Calibration Solution

Increases Technician Productivity
in Excess of 100%

• A Documenting Field Calibrator

Interface Supports the Latest in
Technology for Maximum
Efficiency
ProCalV5 Highlights
• Intuitive User Interface • Unlimited Ability to Expand Tests
• 21 CFR Part 11 Compliance and Procedures for all Desired
• FDA & GxP Compliance Validation & Calibration Activities
• Paperless Calibrations
• Over 70+ Standard Reports • Multiple Devices may be Placed
• Communication with Documenting Under Test Simultaneously and
Process Calibrators Individual Performance Easily
• And much more! Documented

• Calibration Requirements and

Specifications may be Defined
for Discrete Devices, Loops
or Systems

Prime Technologies, Inc

ProCalV5
ProCalLE
Field Calibrator Utility
ProCalLE was developed for calibration professionals
With the use of the Field Calibrator
who need more power and functionality, but a simpler,
Utility, users are able
yet refined economical calibration program. User
to download calibration
friendly, simple, and cost effective. Everything a
assignments & specifications
calibration solution should combine to create the one
directly to a documenting
tool necessary for any professional to enhance their process calibrator. With the
calibration activities. calibrator, the user may then
go into the field and
complete the calibration
assignment in accordance
with the predefined and
approved procedure. The
completed calibration is then easily
and seamlessly uploaded as
electronic calibration records to the
ProCal system database.

Benefits to this process include:

• Efficient use of the latest handheld
field calibration tools
• Elimination of costly calculation or
transcription errors
• Reduction of calibration task
turnaround time

All of the leading field calibrator

ProCalLE Highlights
manufacturers offer products that
• Intuitive User Interface are compatible with the ProCal Field
• Powerful Calibration Entry System Calibrator Utility. They include:
• User-Definable Field Labels
• Control System Access With Secure User ID's
and Passwords
• Over 50+ Standard Reports
• Communication with Documenting Process Calibrators
• And much more!

Prime Technologies, Inc

ProCalV5
HART Communication
HART Communication Software is available either as a stand alone product or to suit your existing
ProCalV5 Calibration Management Software.

Benefits to our HART Communication solution include;

• Perform complete HART device configurations
• Uses the registered DD files from the HART Communication Foundation
• Complete access to all features of the device DD including Methods
• Monitor PV, Multi-variables, Device Status, Diagnostics, & Configurations
• View and edit device Variables
• The most affordable DD based
HART communication solution
available today

Feature Highlights include;

• Windows Explorer menu layout for
ease of use
• Get to the information you want
quickly & efficiently
• Device menu structure easy
to navigate
• Communication and Event Logs
• Complies with new Enhanced
DDL standard
• Comes with all the latest registered
DD's from the HART Foundation

System Requirements Device Descriptions Functions

(minimums) (DD’s) Monitor PV
Operating System: Current Library HCF Release Monitor Multi-variables
Windows NT, Windows 2000, 2006 No. 2 Monitor Device Status
Windows XP Number of devices: 691 View and Edit Variables
Processor Speed: DD Library Included Save complete device
Pentium, 600 Mhz Generic DD Included configuration to text file
Memory: 256 MB DD Updates Quarterly updates Execute Methods:
Hard Disk Space: 500 MB for 1 year free Trims
Monitor: 256-color VGA Calibrations
Communication Port: USB, Loop Tests
RS232, or Bluetooth Zero and Span
HART Modem ProComSol
HM-USB, HM-BT-BAT, or
equivalents

Prime Technologies, Inc

ProCalV5
Product Comparison Chart
Features & Functionality ProCalLE ProCalV5 ProCalV5
Limited Edition Professional Enterprise
Single Account Management
Unlimited Account Management
Number of Instruments Up to 1,000 Unlimited Unlimited
Number of Loops Up to 500 Unlimited Unlimited
Number of Test Standards Up to 200 Unlimited Unlimited
Number of Systems Up to 200 Unlimited Unlimited
Bar Code Enabled
E-Signatures
Change Control
Email Utility (optional add-on)
Field Calibrator Utility (optional add-on)
HART Software Module (optional add-on)
Document Management
Network Ready
MS Access Database
Single Concurrent User License
Five Concurrent User License
Scheduling Tracking
Unlimited User Defined Customizable Fields
Calibration History Tracking
Equipment Management
Advanced Queries and Data Filtering
Calibration Label Printing
Calibration Certificate Printing
Copying Asset Records
File Attachments
Professional Training & Configuration Services
Reporting Tools
Test Standard Reverse Traceability
Vendor Management
Automatic Calibration Due Date Calculation
Customizable User Access & Security
Personalized Skins Menu
Multi-Mode for Rapid Calibration Data Entry
Unlimited Hierarchical Structuring For Asset Mgmt
Calibration Report Trending
ProCal Explorer
Customizable Field Relabeling
Unlimited Number of Unique Users
Archive Utility
Compliant Audit Trails

Prime Technologies, Inc

ProCalV5
Product Comparison Chart (Cont.)
Features & Functionality ProCalLE ProCalV5 ProCalV5
Limited Edition Professional Enterprise
Compliant Audit Trails
Compliance Event Reporting
E-Approval Policies
Mass Update Utility
Mobile Workstation (optional add-on)
PM/WO Module (optional add-on)
Unplanned Maintenance (optional add-on)
Work Order Management (optional add-on)
Test Type Packages (optional add-ons)
Training Mgmt Module (optional add-on)
Shop Admin Utility (optional add-on)
Validation Protocols (optional add-on)
SQL Server/MSDE Database
Oracle Database
Five or More Concurrent Users Licenses
Uncertainty Calculator
21 CFR Part 11 Compliance
Field Calibration Data Entry
Required Fields
DataExchange Utility (optional add-on)

Prime Technologies, Inc

ProCalV5
Powerful. Versatile. Incredibly easy to use . . .

Complex Cal Records Made Simple!

ProCalV5 lets you assign multiple input and output
engineering units, multiple ranges, multiple test
points and multiple tolerances.

You're Always Just a

Click Away!
The new user interface of
ProCalV5 allows you to open
and run multiple screens at the same time. No matter how many
screens are open, you are just a mouse click away
from any place you want to be.

Instrument/Record
Setup Follows a Logical Path!
One of the features that makes set up so easy in ProCalV5 is
the way it allows you to create instrument records. First enter
the general instrument information. Next, enter the calibration
information template data such as accuracy, input/output
ranges, etc. Then enter the selected calibration points, press
the calculate button, and you're done!

Don't Bring Your Calculator!

As instrument test point data is being set up,
ProCalV5 will calculate correlations of input/output
engineering units and high/low limits for each test
point. During and after instrument calibrations, the
program warns for out-of-tolerance data entry.
ProCalV5 does it all . . . so you don't have to!

Prime Technologies, Inc

ProCalV5
Overview of ProCal Features
User Interface
• Centralized ProCalV5 Explorer Toolbar boosts
efficiencies
• Sleek design for more intuitive use by end users
and management
• "Skins" Mode for Personalization of the Home
Screen
• Streamlined Reminders and Notifications for
immediate notice
• Updated Graphical User Interface
• Shortcuts from Toolbar for Calibration or
Maintenance entry

Reporting
• Includes comprehensive list of reports
• Create custom reports using Seagate Crystal
Reports
• Export data directly to Microsoft Excel
• User defined queries may be saved and reused
as developed or used as the basis for other
queries
• Reports can be developed to collect and
incorporate data from other applications

Paperless Calibrations
• 21 CFR Part 11 Compliance
• Assign work electronically to portable devices
• Mobile Workstations display the full user interface
with complete system functionality
• Automatically calculate signal correlations, test point
tolerances, and check data entry tolerances.
• No need for written out calculations or calculator use!
• Reminders, warnings, alerts and approval routings
can be automatically transferred via email, LAN
or WAN

Prime Technologies, Inc

ProCalV5
Overview of ProCal Features
Test Type Packages
• Custom Test Type Package algorithms can be
designed to suit any requirement regardless of
the complexity
• Useful for HPLC, Spectrophotometer and other
laboratory devices
• Create any type of special testing for power,
electrical and other equipment & systems
• Custom reports can also be developed to each
test to match your exact specifications
• Libraries of existing test sets are available
including Uncertainty Calculations

Compliance Management
• Approval Policies with multiple signature
routings may be defined
• Master Record Change Control
• LDAP authentication capable
• Fully Validated before release
• Multiple unlimited forced E-Signature Routings
• Audit Trail & Audit Trail Reporting Capabilities
• Fully compliant Mobile Workstations
• Out of Tolerance compliance reporting
• DUT & Test Standard Controls

Planned Maintenance & Work Order Management

• Complete approved calibration specification that can be
presented for execution
• Perform multiple Real Time / Paperless calibrations
simultaneously
• Controlled changing of test point values in the field and
auto calculate new limits
• Automatic notification for out of tolerance recorded date
• Electronically record test standards used from an
approved list
• Ability to view important and pertinent documents
• Manage work assignments and workflow
• Establish rules and practices electronically
• Manage and track Change Control

Prime Technologies, Inc

ProCalV5
Prime Technologies Services
The Prime Technologies professionals responsible for the development of the incomparable
ProCalV5 Calibration Management Solution have the experience and expertise to help you
achieve compliance & quality objectives. They are available to assist with Specification
development, Project Planning & Management, Procedure & workflow refinement, Testing,
Validation and more.
With ProCalV5, calibration managers and technicians alike benefit from a superior off the
shelf solution and through our professional support team, they are assured a successful
solution implementation.

Implementation Services
When implementing a new
Calibration Management Software
system, costs associated with this
venture should be understood.
Complete implementation costs including
installation, training, validation, and other
operations are usually underestimated.
Managing the implementation of a new system should be
left to responsible parties, those who understand this
process and can manage the problems and greatly reduce
hidden costs. Many companies wait to implement, causing
return on investment to be reduced.
But in response to this issue, many organizations look to
outsource implementation and validation projects to Prime
Technologies. This allows the company to reap greater Other Services Performed Include
benefits with our implementation professionals. • Specification Development
• Project Planning & Management
• Custom Report Development
Integration With Other Systems • Design of Calibration Test
Type Packages
Does your organization use separate applications in order to • Application Training
satisfy its day-to-day business operations? Do these • Data Migration
applications require their own database and handle uniquely
different data? At Prime Technologies we understand this
process, and have developed the tool in order to satisfy your
desire for a solution that can integrate with your other
systems.
Make maximum use of the best of breed solutions or enhance
systems already in place with ProCalV5 application
integration from Prime Technologies.

Prime Technologies, Inc

ProCalV5
Prime Technologies Services (Cont.)
Validation & Testing
Looking to eliminate time associated to develop internal testing scripts, time of personnel to validate a new
system, and complete an implementation in a matter of weeks, not months or maybe even years?

With Prime Technologies Validation & Testing assistance, your company can eliminate these costly
problems. From the first meeting to post validation meetings, Prime Technologies well structured
and documented processes not only help ensure an organization's validation goes smoothly, but on time
as well.

Prime Technologies Subject Matter Experts will tailor Administrator, Manager and User Training to suit
your unique requirements;
• Validation Strategy Document
• Risk Assessment
• Test Plan
• Installation Validation protocol development, IQ
• Operation & Performance Qualification Protocol, OQ, PQ
• Supervision and execution of Validation and UAT
• Validation summery documents

Prime Technologies, Inc

ProCalV5
Why Prime Technologies?
Why Choose Prime Technologies Inc.
For your System Implementation Service Provider?
Here's Why!
Prime Technologies offers a wide array of solutions for those seeking professional Calibration Software. With
over 10 years of experience in regulated and non regulated industries, ProCalV5 has been specifically
designed for those in search of a scalable and economical software package, including procedures designed
to reduce risk, maximizing your organization's return on investment and much more.

Computer software implementation, validation, training and various other aspects to a new investing in a new
solution takes significant time and resources that can be more effective with vendor participation because…
o Appropriate & Realistic Project Objectives avoiding pitfalls and misdirection that
could delay success
o Effective use of application functionality resulting in increased calibration software utility and
decreased production costs
o Prime Technologies, Inc. has been there before - Successfully!

Vendors perform a higher level of testing than users and…

o Thousands of hours have gone into developing and refining our validation test scripts,
product knowledge and developing an intuitive program
o We know how to leverage our knowledge into your testing efforts
o Leads to increased testing acceptance by your Quality & Compliance practices

Overview Of Our Solutions

ProCalLE - Developed for calibration professionals who need more power and functionality, but a simpler,
yet refined economical calibration program. User friendly, simple, and cost
effective…Everything a calibration solution should combine to create the one
tool necessary for any professional to improve their productivity.

ProCalV5 - From the beginning our mission has been to develop, and
through continuous improvement, maintain for our users a software
product far superior to anything else in the market. Whether your
needs include a truly paperless compliant real time calibration
management solution to a reporting tool or simply a scheduling and
alerting system, ProCalV5 is the right choice. Its versatile design
and scalability make it the right system for the small business or
large corporate enterprise.

Services - With years of experience in calibration management and

the life science industries, our services incorporates all the experience
and quality management practices obtained from countless
implementations and validations. With our fully certified technicians
and quality calibration management software, Prime Technologies Inc.
will exceed your expectations forcalibration management software
solution provider.

Prime Technologies, Inc

ProCalV5
Testimonials
Increasing calibration efficiency was also the driving force behind John Kuehl's recent decision
to purchase ProCalV5 software for Cangene, a world leader in the development, manufacture,
and commercialization of specialty hyper immune plasma and biotechnology products. "In
addition to the technology, our choice had a lot to do with the expertise of the people behind the
product",…explains Kuehl, who is Manager of Controls/ Metrology for Cangene.

John Kuehl
Metrology Manager
Cangene Corp.

When asked what helped their organization select ProCalV5, Fred explained that, "the overall
versatility of the program compared to other software was exactly what we were looking for.
Versatility and easy navigation from screen to screen was what set ProCalV5 apart from the
competitors."
Fred Starr
Team Leader
SPI Pharma

Prime Technologies, Inc

ProCalV5
Contact Prime Technologies
today to learn more!
For more information on functionality, reporting capabilities and how
our software solution can benefit your organization, contact Prime
Technologies today. For immediate information, please visit our website
where you can download a demonstration of our software to learn more
about its features and versatility.

20 Hagerty Blvd ~ Suite 1

West Chester, PA 19382
Phone : 610-436-9703 ~ Fax : 610-436-9097
(800) 440-7501
www.primetechpa.com
[email protected]

Prime Technologies, Inc

ProCalV5