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Publication Date: July 1, 2009 Product Handout: 01

Compliance Management Solutions

QAvalid™ - Managing and controlling spreadsheets Microsoft Excel

is widely available, has comprehensive functionality and very flexible spreadsheet application. However, it is a major source of regulatory non-compliance when used in a GXP regulated environment as it is not compliant with the technical requirements of 21 CFR 11 (Electronic Records; Electronic Signatures final rule).

Despite this, it can be surprising to find that almost half of all critical quality and compliance records managed within the Life Science Industry are created and maintained using Excel. The problem with using spreadsheets in regulated environments is that they introduce huge business and compliance risks. Most importantly, the FDA’s 21 CFR 11 requirements for electronic records and electronic signatures are not met due to a series of weaknesses which include: poor security and data integrity, the ability to overwrite data without attribution, lack of audit trails to monitor changes which result in slow and expensive manual procedures and the lack of electronic signatures. QAvalid is a validation management tool that with the introduction of version 2 has the ability to manage and control Excel spreadsheets in addition to Word documents. The QAvalid Excel version is specifically set up for spreadsheet management only.

Why QAvalid? Is an unobtrusive solution, which enables user to continue working in Excel, but eliminates the significant business and compliance risks of unauthorized access or modificationof critical data Provides automatic audit trails, version control and version numbering, reducing the need for manual methods to monitor changes to data or manage versions Supports centralized spreadsheet management enabling overview and control over all critical workbooks from any location using a web interface

Clarmon - QAvalid™ - Managing and controlling spreadsheets

By supporting electronic signatures eliminates the need for hand signed paper printouts which consume significant time and effort to manage Allows you to turn all your validated Excel workbooks into 21 CFR 11 technically compliant workbooks. Is a simple and rapidly implemented solution which allows users to validate their Excel templates and ensures that once validated, the workbooks are controlled and that GxP requirements are met

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The main challenges in meeting Part 11 compliance using Excel

Poor Security

No electronic signatures Excel does not support electronic signatures and printouts of the documents have to be generated to permit handwritten signatures.

There is no automatic audit trail and so there is no way to identify and track the changes made to a particular spreadsheet.

Lack of audit trails

Workbooks are commonly stored on shared drives and are not protected against unauthorized access or changes to files. Password expiration, user lockouts and time session lockouts are not available

Changes to spreadsheets are not implemented based on formal change control procedures; older versions are commonly overwritten or deleted.

Lack of change and version control

QAvalid key features and benefits Control access and change of critical spreadsheets Once added to QAvalid, spreadsheets can only be accessed by authorized users based on user name and password and different privileges can be assigned to different users. Password expiry and session lockout as well as user access lockout intervals can be configured by the administrator. Automatic audit trails Automatic, time stamped audit trails record the changes made to each cell, the user who made the change, as well as the previous value. The audit trail also records changes to the system settings or configurations that can be made by advanced users. This ensures that each workbook meets Part 11 requirements for audit trails. Electronic signatures Compliant electronic signatures enable users to promptly sign workbooks and eliminate the need for creating and maintaining paper printouts as

Clarmon - QAvalid™ - Managing and controlling spreadsheets

evidence. This significantly lowers the costs of compliance as electronic records are cheaper to maintain and easier to retrieve than paper printouts. Integrated change and version control Electronic change control workflows supported by automatic audit trails are used when implementing modifications. All document versions remain stored in the system and change requests can be linked to the document version showing what changed, why and who approved it while audit trails demonstrate that changes have been implemented consistently. Centralized and automated versioning QAvalid controls workbook versions and ensures that users can always locate or reference the latest version. This helps ensure that users consistently employ the correct templates, thus avoiding tedious remediation efforts triggered by errors.

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Compliant test execution in Excel QAvalid supports the entire spreadsheet lifecycle from draft creation to record archival. An added toolbar allows users to attach comments, perform compliant test execution and result capture in Excel. Linksense™ traceability Linksense™ technology enables users to connect related content across separate documents or within the same document. The electronic references warn users when a workbook needs to be updated due to changes in a related file and support creating an overview of content dependencies and identify change impact.

Clarmon - QAvalid™ - Managing and controlling spreadsheets

Reduce risk of non-compliance QAvalid allows users to track workbook proprieties, thus enforcing compliance. The effective date, review schedule and retention period can be tracked for each workbook. Improved overview and central control Workbooks can be promptly retrieved from any location using the QAvalid centralized web interface. Reports are available presenting real-time information about each workbook, the users working with it and the status of each task.

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QAvalid™ , Clarmon’s quality and compliance management suite, provides a simple method to centrally manage and control documents without requiring users to reenter information. Unique technology embedded in QAvalid™ allows quality professionals to connect and synchronize documents and regulations, drastically reducing the time needed to update documents. QAvalid™ helps companies improve their efficiency in managing the following processes: • Computerized System Validation • Facility Commissioning and Qualification • Corrective and Preventive Actions • Equipment Inventory Management • Change Management • Audit Management

Clarmon Corporation

Clarmon Compliance Management Solutions

Clarmon Corporation provides advanced software solutions for quality and compliance management. The majority of Clarmon’s customers are Life Science companies that operate inside one of the most highly regulated environments.

© Copyright 2009, by Clarmon Corporation This material is copyright and all rights of confidentiality are reserved. Other than for the purposes of and subject to the conditions prescribed under the Copyright Act, no part of it may in any form or by any means (electronic, mechanical, micro copying, photocopying or otherwise) be produced, stored in a retrieval system or transmitted without the prior written permission of Clarmon Corporation.

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