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PRODUCT INFORMATION BULLETIN

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Product<br />

Name:<br />

PharmSpec<br />

Issue Date: 10-29-10<br />

PIB No: 30-112<br />

<strong>PRODUCT</strong> <strong>INFORMATION</strong> <strong>BULLETIN</strong><br />

.<br />

PharmSpec 3.0 Backwards Compatibility and New License<br />

Options<br />

NOTE: This document is for internal use only. It should not be forwarded directly to customers or potential<br />

customers. However, you are encouraged to use appropriate information to prepare sales or promotional materials.<br />

Topic: Choose a topic<br />

Product Launch Product Obsolescence Product Change/Update/Other<br />

Introduction: The purpose of this PIB is to announce the release of PharmSpec 3.0 for<br />

backwards compatibility with the legacy HIAC 9703 and 9705 instruments. We would also like<br />

to announce additional licenses available for Pharmspec 3.0 users and database procedural<br />

update to USP33.<br />

Call to Action:<br />

Inform sales and service personnel of feature availability and provide guidance to<br />

appropriately address customer questions.<br />

Key Message Points:<br />

Pharmspec 3.0 is now backwards compatible on legacy HIAC 9703 and 9705<br />

instruments.<br />

USP license available for compendial tests for ophthalmic manufacturers.<br />

Procedure Distributor license available<br />

R&D mode (no 21 CFR part 11 security) license available.<br />

Database procedural update available for USP33 (www.hach.com/HIAC) on or before<br />

November 5 th , 2010<br />

Attachments:<br />

Brochure - English<br />

Brochure – Spanish<br />

Brochure - German<br />

Brochure - Italian<br />

Brochure - French


Summary:<br />

At initial release, PharmSpec 3.0 was only compatible with the HIAC 9703+. After thorough<br />

testing on legacy HIAC 9703 and 9705 instruments, we now are releasing the sale of<br />

PharmSpec 3.0 for use on older instruments.<br />

Please note: PharmSpec 3.0 will recognize a legacy 9703 automatically and the User Interface<br />

will only allow PharmSpec 2.2 feature sets.<br />

USP 33 database procedure updates will be available on www.hach.com on or before<br />

November 5, 2010.<br />

A brief summary of the new PharmSpec license keys for additional features is as follows:<br />

USP 789 license enables standard large volume sample size testing to comply with the<br />

USP 789 ophthalmic regulation.<br />

Procedure distributor allows clients to distribute unique test recipes between PharmSpec<br />

licenses, commonly required on sites that use multiple HIAC 9703+ instruments.<br />

R&D mode (no 21 CFR part 11 security) license removes all 21 CFR part 11 security<br />

protocols on the PharmSpec 3.0 software. Users don’t have logins, user administration,<br />

or electronic signings which are controlled by 21 CFR part 11 security protocols.<br />

The next release of PharmSpec 3.X software is targeted for March/April 2011. This release will<br />

include:<br />

Local language translations (German, French, Japanese, Italian)<br />

Updated archive database reviewer that will eliminate the need to attach/detach primary,<br />

archived or historical databases when using 3.0<br />

USP34 (providing USP stays on schedule)<br />

The PharmSpec 3.0 software and optional licenses are highlighted in bold below.<br />

700060GP<br />

License, PharmSpec 3.0 Base Program only<br />

700057 License, USP compendial tests<br />

700059 License, JP compendial tests<br />

700058 License, EP compendial tests<br />

700056 License, KP compendial tests<br />

700049 License, USP compendial tests<br />

700050 License, Procedure Distributor<br />

700052 License, R&D mode (no 21 CFR part 11 security)<br />

700055 License, Procedure Builder for custom tests.


Internal Contacts-direct questions to:<br />

Location Contact Function Email<br />

US, EU,<br />

ROW<br />

US, EU,<br />

ROW<br />

International<br />

Distributors<br />

Paul Yates Product Manager pyates@hach.com<br />

Dave Dunham Associate Product Manager ddunham@hach.com<br />

Contact your sales support person<br />

Frequently Asked Questions:<br />

Q. What is the price for new PharmSpec licenses<br />

A. Depends upon your world area location, but all new licenses are identical in price to<br />

standard USP, EP, KP, and JP license prices.<br />

Q. The OS on my PC is 64-bit Windows 7—will PharmSpec 3.0 install properly on this OS<br />

A. At this time PharmSpec 3.0 will only run on 32-bit OS. The code has not been optimized to<br />

run on 64-bit. A future communication will be issued when 64-bit compatibility is available.<br />

Q. How do I purchase PharmSpec 3.0 Can I download my new copy of PharmSpec 3.0<br />

A. Please contact your Regional Sales Manager for a quote. All customers will be shipped a<br />

new copy of PharmSpec 3.0 on CD.<br />

Q. I currently have PharmSpec 2.X on my PC. Is there anything I need to be aware of that<br />

might prevent a successful install of PharmSpec 3.0<br />

A. System requirements are outlined in the PharmSpec 3.0 User Manual and should be<br />

reviewed prior to install to ensure minimum requirements are met. The table below shows<br />

the minimum requirements.

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