NEW QUMAS Client Webinar Series*

The January 1, 2008 deadline for eCTD has come and gone, challenging more and more companies with making the changes that come when transitioning from paper or legacy format submissions to eCTD. The primary challenges revolve around managing not only the document lifecycle of individual submission documents but managing the submission lifecycle itself. The eCTD format is designed to enhance the full lifecycle of a submission, not just the individual application.

In this 45 minute presentation, Patricia Santos Serrao RAC, Manager of Global Regulatory Solutions at QUMAS, will discuss and demonstrate QUMAS solutions for the following topics:

• Implementing solutions for the authoring of eCTD compliant granular documents for all functional areas contributing to an eCTD
• Different approaches to implementing solutions for electronic records management as well as requirements for electronic signatures
• Tips and advice on configuring taxonomy, document types and streamlining the creation, authoring, reviewing and approving of documents
• Time saving tips on building your submissions to minimize workload as submission deadlines approach

One challenge that is faced by all life sciences companies is the management of bulk content. With the shift to migrating from paper paradigms to electronic, as well as the frequent engagements with external resources such as CROs and CMOs, the need for managing the importing and exporting of content to and from a controlled repository in a streamlined fashion becomes critical.

In this 45 minute presentation Patricia Santos Serrao RAC will discuss and demonstrate solutions for the following topics:

• Bulk Loading tools for manually importing bulk content
• Rules based approach to import automation; allowing your technology to do the work for you.
• Getting the most benefit out of your scanning solutions in managing controlled documents; producing agency compliant scanned output

As companies become more virtual and global, the need for fluid partnerships and sharing of information while maintaining control over intellectual property becomes a challenge in every industry, particularly in Life Sciences. For example, companies rely on Contract Manufacturer Organizations (CMO) to produce their products and Clinical Research Organizations (CRO) to conduct their clinical trials. With these partnerships comes the need for collaboration and sharing of documents and information: using email and 'Track Changes' doesn't come close to providing the level of functionality and control that is required.

In this 45 minute presentation QUMAS Global Regulatory Affairs Manager, Patricia Santos Serrao RAC, will discuss and demonstrate QUMAS solutions for the following topics:

• Simplifying workflows to streamline processes from creation to approval.
• Realtime web-based collaboration with internal and external resources
• Overcoming the challenges and current limitations of linear method of checkin / checkout for editing of documents
• Extending external partnerships without compromising security

In this session, Cyril Walsh, Solutions Consultant at QUMAS, discusses the key considerations for managing deviations and corrective and preventive actions (CAPA). Cyril takes a deep dive into the forms that are required, the roles that are involved and the workflow that harnesses business rules to determine the route taken to completion and sign off.

This 45-minute presentation focuses on what a good deviation and CAPA management system should include:

• Forms for tracking issues that occur across the organization, so that deviations can be identified, logged, tasks assigned, resolutions identified, and executed
• Corrective or preventive action plans that are automatically routed to employees
• Updated policies, procedures and SOPs based on the outcome of the corrective actions
• Point in time reporting for management or for regulators who are investigating a particular issue, and dashboards for executives

In this session, Cyril Walsh, Solutions Consultant at QUMAS, discusses the key considerations for Audit Management. Cyril takes a deep dive into the forms that are required, the roles that are involved and the workflow that harnesses business rules to determine the route taken to completion and sign off.

This 45-minute presentation focuses on what a good audit management system should include:

• Forms for tracking the audit, capturing whether it is internal or external, audit findings, including non-conformances, observations, and recommendations
• Focus on Non-Conformance identification and resolution
• Updated policies, procedures and SOPs based on the outcome of the nonconformance
• Creation of audit report, follow-up actions, and generation of the ‘Certificate of audit’
• Point-in-time reporting for management or for auditors who are responsible for the audit, and dashboards for executives

In this session, Cyril Walsh, Solutions Consultant at QUMAS, discusses the key considerations for Change Control. Cyril takes a deep dive into the forms that are required, the roles that are involved and the workflow that harnesses business rules to determine the route taken to completion and sign off.

This 45-minute presentation focuses on what a good change control system should include:

• Forms for tracking the change control, capturing the details of the impacted areas, the decision flow, and departments/sites involved
• Tracking the change through the phases: Initiation, Impact Assessment, Evaluation, Execution, Implementation and Closure
• Updated policies, procedures and SOPs based on the outcome of the change control
• Point-in-time reporting for management or for change owners who are responsible for the change, and dashboards for executives

Across all organizations today, a major driver is the ability to do more with existing resources by enabling employees to work more efficiently. Part of that drive is a single, integrated platform for Compliance and Risk delivered in one common interface that allows stakeholders in the company to make risk-based decisions, access integrated workflow processes and have visibility into an effective closed-loop process through that common interface.

My QUMAS is a single interface that delivers a zero training User Interface for viewing, printing and completing a large number of tasks that have been routed to the end user. By providing access to all Compliance related areas of the organization, from both QUMAS and third parties, in a single solution, productivity is greatly increased.

During this 45 minute webinar, QUMAS Compliance Advisor, Warren Perry, will demonstrate the My QUMAS solution and highlight the benefits it provides. Among others, these benefits include:

• Proactive regulatory defense
• Improved quality and manufacturing operations
• Reduced costs of compliance
• Increased customer satisfaction
• Ability to adapt quickly to manufacturing changes
• Reduced time to market

Are you thinking about upgrading from QUMAS DocCompliance version 3.3 to 4.x, or are you a current 4.x user who is interested in getting more from the system?

This presentation will showcase the new functionality in the latest version of DocCompliance. The focus will be on the end-user experience, with special attention to:

• Usability: Bulk Updates, Copy Document, Mark Read and Understood, Pick List Dependencies, Simplified Printing and Search (Content & Metadata Combined)
• Streamlined/Enhanced Workflow: Activate, Auto Promote, Meaning of Signature (Approval & Disapproval), Removal of Associations
• Lifecycle Enhancements: Direct Lifecycle States, Signatures

DocCompliance 4.x contains several enhancements that are designed specifically for users in Regulatory Affairs and Clinical Ops, as well as Quality and Manufacturing, so both current users as well as employees from departments considering using DocCompliance are encouraged to attend.