HPLC qualification enters a new era - one addressing both business and compliance needs in laboratories – with the Unity Paperless HPLC Protocol, which enables users to perform an entire HPLC IQ OQ and produce the final report in less than 2 hours.

The Unity protocol with enhanced iPad® capabilities automates and streamlines qualification tasks while ensuring all regulatory require-ments are met, including GLP, GMP, and USP <1058> AIQ. With electronic signature and date-and-time stamps, the Unity paperless universal HPLC IQ OQ Protocol meets 21 CFR Part 11 requirements.

The Unity protocol reduces human error via automated calculations and reports. And the electronic publishing features streamline the re-view process and simplify record keeping.

Say goodbye to paper and binders. Your protocol is self-contained in the iPad or your laptop: Your qualification document, test requirements, and automatic calcula-tions are all included. Enter information about your company, the HPLC compo-nents, test equipment, standards, reagents, supporting documents, and you have a fully compliant IQ, OQ document.

During testing, enter acceptance criteria and test results via the incorporated digital keyboard. Add attachments. Make comments. To add your signature, pick up a stylus and sign – right on the screen. Or add your electronic signature. Or print the document, then sign. The Unity Paperless HPLC Protocol lets you work the way you want to.

Seeing is believing. Contact us to experience the next generation of qualification:

Lab Compliance Solutions 2647 Gateway Road, Suite 105-460 Carlsbad CA 92009 Phone: 760-707-2974 Website: LabComplianceSolutions.com

► Paperless

► Universal

► Validated

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Making HPLC Qualification ...

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Making compliance swift. Making compliance efficient.

©2011 Lab Compliance Solutions. All rights reserved. iPad is a registered trademark of Apple Inc. All other copyrights and trademarks are the property of their respective owners.

Lab Compliance Solutions 2647 Gateway Road, Suite 105-460

Carlsbad CA 92009 Phone: 760-707-2974

www.LabComplianceSolutions.com

Paperless Universal HPLC Qualification Protocol

Meets GLP, GMP, and USP <1058>

AIQ requirements

Includes all current test procedures to

satisfy global regula-tory guidelines.

Just select your test for each component, then enter limits and

test data.

Instant test results, no calculator or elec-

tronic spreadsheet is needed.

Automatic Built-in Calculations

Based on standard industry testing for:

■ Column oven/sample tray temperature accu-racy & stability

■ Pump flow rate accuracy & precision

■ Gradient composition accuracy & linearity

■ Detector wavelength accuracy, linearity, carryover, noise & drift

■ Autosampler injection precision & linearity

Step-by-Step

Detailed instructions guide user through procedures, which are based on global industry & regulatory guidelines.

Features Benefits

Compliance

Employs current industry, GLP, GMP, and AIQ <1058> AIQ recommendations. It covers all necessary testing required to qualify the HPLC components and system.

Ensures your HPLC system and its components are fully compliant, based on global regulatory guidelines.

Validated arithmetic engine for calculating results instantly and automatic PASS/FAIL alerts. Certificate of Compliance verifies calculations are validated.

Speeds qualification by eliminating errors in manual calculations or non-validated spreadsheets. Eliminates errors in comparing test results with acceptance limits.

Electronic signatures and time/date stamp; compliant with 21 CFR Part 11. Electronic signing streamlines approval process; ensures compliance.

Universal IQ OQ protocol – for all HPLC systems, no matter the manufacturer, and for all components, including UV-Vis, FLD, RID, and MSD detectors.

Enables harmonized documentation, as recommended by USP AIQ <1058>, and simplifies lab administration: One protocol covers all HPLC systems, globally.

Protocol Features

Available on either an iPad or for installation on a laptop or network PC, enabling data entry via keyboard.

Works the way you want to – on an iPad or a laptop. Enter data easily and conveniently as you test. Keyboard entries eliminate the shortcomings of handwriting, such as illegible words and numbers.

Protocol guides users through the Installation and Operational Qualification. “Smart” features include tool tips to help enter data correctly.

Reduces human error by ensuring there are no missed steps, no guessing. User-friendly format makes the document simple and straightforward to use.

Includes entries for all necessary data, such as company and HPLC information; test equipment; standards; reagents; and attachments.

Ensures all data required for a compliant qualification is recorded.

Fields include data-entry safeguards, such as requiring numbers in a number field or alerts for blank fields. Includes ‘Comment’ fields for additional information.

Improves accuracy by restricting data to acceptable formats and ensures all data is provided. Comment fields provide additional insight for reviewers and auditors.

Reporting Capabilities

Automatically creates the final document, complete with summary report, attachments, comments, electronic signatures, and time/date stamp.

Reduces time spent on paperwork. Enter the test results and when the last entry is done the Unity protocol produces the final document instantly.

Paperless compliance capability. Final document can be sent to reviewers electronically, then signed and dated electronically as well.

Streamlines document review and shortens time spent finalizing documentation.

Can be printed or saved as a fully 21 CFR Part 11 compliant and locked PDF. Streamlines archiving to meet regulatory requirements with flexibility to meet your company’s compliance policies.

Protocol allows for attachments or references to attachments, such as test equipment certificates, standards, training, or raw data.

Built-in step allows all associated documents to be attached or referenced appropriately to meet regulatory requirements.