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DocumentChangeControlfor Quality & Regulatory ComplianceQuality and Compliance SolutionsDocument Control Softwarefor Microsoft Windows
Document Change ControlImprove efficiency andenforce consistencyIntroducing document change control by ColumbiaSoft.Bring products to market faster, reduce financial risk stemming from lost orincorrect information, and improve compliance with regulations and standards.Manage the completedocument lifecycle: Change RequestCreation / editReviewApproveTrainingPublishingArchiveSupports both Electronic &Digital SignaturesFDA 21CFR Part 11 CompliantISO 13485 CompliantUpload your existing documents andget started quickly.Document Change Control byColumbiaSoft strictly controls: Revision LevelRevision AuthorEffective DateChange Control NumberBuilt on ColumbiaSoft’s DL document control platform, theDocument Change Control module is designed to improve theeffectiveness of quality and compliance programs. 2012 ColumbiaSoft Corporation. All Rights Reserved
for Quality & Regulatory ComplianceDocument Change ControlThe Document Change Control repository (DCC) provides an out of the boxstructured methodology that automates the traditional manual documentchange control procedure.Empowering Process OwnersThe system is designed so that Process Owners haveend-to-end responsibility for their documents. Processowners design the process, and process teams carryit out, overseeing their own work and making all theday-to-day operating decisions required to keep thingsmoving smoothly.The complete lifecycle of documents: template management, documentchange request, creation/edit, review, approval, training, distribution, archiveand obsolescence everything is managed in the system. You can uploadyour existing documents to get started quickly. Full text search allows you tofind documents in seconds.Role based workflows enforce best practices and consistency.Workflow participants are automatically notified of their assignmentsvia email. Workflow reminders and escalationskeep workflows on schedule.Security and access privileges are controlledby user roles and user groups dependentupon the associated process. New or reviseddocuments are automatically published andprior versions are archived.DL version control maintains versions ofdocuments throughout their lifecycle. TheDocument Log tracks when a documentwas accessed, who accessed it, and whataction was taken. Reporting provides acomprehensive set of reports to track thestatus of documents and monitor trends.“A recent FDA auditclearly demonstratedthe value of DocumentLocator by reducingthe time it took us toretrieve requestedrecords in half.”The Anspach Effort, Inc.The system supports both electronic signatures and digital signatures, incompliance with ISO standards and 21 CFR Part 11. System validation isfacilitated by a comprehensive set of validation scripts.800.298.1172www.ColumbiaSoft.com
Document Change ControlThe document change control processStepDescriptionChangeRequestThe change request process is used to document the request forchange, the reason for the change and the impact of the change.The process is also used to assign user roles: Revision Author,Review & Approve, and Training.Create/editThe create/edit process is initiated when the assigned RevisionAuthor receives a workflow notice that they have been assignedto either create a new document or edit an existing document.ReviewOnce the assigned task has been completed, the Revision Authorchecks in the document and starts the Review workflow whichallows the assigned reviewers to collaborate on the edits to adocument until all reviewers are in agreement.ApproveThe approve workflow is used to approve the document.DL supports both electronic signature and digital signaturetechnologies that comply with 21CFR Part 11.TrainingWhen training is required, the system provides two methods.Employee review or Supervisor training. Both methods providean audit trail of training provided.PublishingArchiveThe final step in the process publishes a copy of the signed PDFversion of the document in the Released Documents folder. Ifthere is a prior version it is automatically replaced with the mostcurrent approved version.Records management archives the document per predefinedschedules. 2012 ColumbiaSoft Corporation. All Rights Reserved
for Quality & Regulatory ComplianceFull-integration within the Microsoftarchitecture makes document changecontrol easyDocument Change Control is fully integrated into Microsoft Windows whichmakes it easy and intuitive to use. Simply right click on a document to access amenu of document control commands.Column headings display theTitle, Revision Level, ChangeControl Number, Date Effective,Revision Author and DocumentStatus for the SOP’s in this folder.In this example the History menu isselected which then shows sub-menusfor workflow and log histories.800.298.1172www.ColumbiaSoft.com
Document Change ControlDocument change control reachesbeyond the office wallsPeople working outside the office who are authorized for access canretrieve documents and participate in workflows over the Internet. Theself-hosted Web access provides users with an interface that closelyresembles the desktop experience.A new mobile interface (2012 release)extends the reach of files in thedocument control system worldwideon mobile devices and tablets. 2012 ColumbiaSoft Corporation. All Rights Reserved
for Quality & Regulatory ComplianceInsightful business intelligence forsmart decision-makingReporting is critical for managers to make timely decisions. Acomprehensive set of reports for monitoring system configuration, usage,throughput, and trend analysis are included. Reports are numbered,categorized and named for easy access. Plus, you can add your owncustom reports.Reports track the status ofdocuments being changed inthe system.Chart reports allow youto analyze trends in thesystem. Users can drilldown to see the detail.800.298.1172www.ColumbiaSoft.com
ColumbiaSoft quality andcompliance solutions CAPANon-conformanceCorrective ActionEmployee TrainingECOCertification Packages Document TransmittalsAccounts Payable ProcessingHuman ResourcesContract ManagementProject ManagementFirst Article PackagesSEE HOW IT WORKSColumbiaSoft is a leading provider of enterprise document control solutions.Since 1998, we’ve been helping businesses and government agencies with intelligentsolutions to meet regulatory compliance and improve quality. Our solutions are fullyintegrated with Microsoft and other leading software technologies, making it easy forpeople to use.We are headquartered in the United States, and provide all development, support, andservices from the U.S.Contact us to learn more.800.298.1172www.ColumbiaSoft.comColumbiaSoft Corporation15495 S.W. Sequoia Parkway, Suite 190Portland, OR 97224
The Document Change Control repository (DCC) provides an out of the box structured methodology that automates the traditional manual document change control procedure. Empowering Process Owners The system is designed so that Process Owners have end-to-end responsibility for their documents. Process owners
