OPERATIONALIZING EXCELLENCE IN THE GLOBAL REGULATORY SUBMISSIONS PROCESS

INTRODUCTION As life sciences companies face expiring patents and shrinking drug-development pipelines, it’s never been more important to streamline the regulatory submissions process and get products to market faster. But to date, most systems for authoring, managing and submitting regulatory documents have had serious limitations in key areas for regulatory submissions professionals.

For example, the process itself has become more complex due to constant changes in regulations on documentation and increased outsourcing of business processes. As a result, companies need solutions that support reliable, seamless and simultaneous collaboration between geographically distributed people, regardless of whether they are frequent or occasional participants in the document authoring process.

As a leader in enterprise content management for the life sciences industry focused on hundreds of industry customers, EMC offers a unique perspective on both current trends and real needs. This paper takes a fresh look at what makes the regulatory submissions process so unique and challenging, and envisions how software solutions can better support the process with innovative functionality.

EMC PERSPECTIVE: DOCUMENTUM FOR LIFE SCIENCES

TABLE OF CONTENTS

INTRODUCTION 1

UNIQUE CHALLENGES 3

ENVISIONING A BETTER WAY 4

A Unified Document Repository 4

Structured Templates, Best Practices and Reference Models 4

Workflow-Driven Collaboration for Authoring, Reviews and Approvals 5

Efficient Document Management for Faster, Easier Search 6

Enterprise Mobility 6

Agility 7

Broadening the Vision 7

EMC DOCUMENTUM FOR LIFE SCIENCES 7

UNIQUE CHALLENGES As a regulatory submissions professional in the life sciences industry, you are challenged by work involving a unique set of characteristics that make it incredibly difficult—and absolutely essential to the overall success of your company. From a high-level perspective, the process of authoring and submitting regulatory documents is:

• Mission critical to business profitability and growth — because your business can’t make money on unapproved drugs, no matter how good they are.

• Highly complex — involving large numbers of documents and data that must be managed, aggregated from internal and external sources, organized and made readily accessible to regulatory operations and other knowledge workers in the organization.

• Intensely collaborative — involving many reviews, handoffs and approvals with hundreds of internal and external colleagues.

• Time sensitive — because every day that drug approvals are delayed is time lost on patent protection—and time that competitors can use to beat you to market.

• Exacting — because government regulators in different countries require 100% compliance with their sometimes unique set of submission requirements.

• Periodic — because many of the people involved in authoring documents engage in these tasks only infrequently.

It’s worth noting that this last characteristic, periodic, is quite unique. What other industry has a process so complex and so fundamental to its mission—yet many of its key participants are expected to get it 100% right, even after being away from it for long periods of time? You’ll be hard pressed to think of one. Expertise, accuracy and flawless execution result from doing something repeatedly; when this is not the case, and people lack the right process support, excellence in all areas is elusive.

Within most industries, processes with these characteristics are typically supported by powerful software designed to support the execution of specific daily tasks. For example, software can provide people with automated workflows, templates, checks, reports and collaboration to help them manage and carry out tasks consistently, accurately and without errors.

But to date, most offerings for authoring, managing and submitting regulatory documents have had serious limitations. For example:

• Trying to follow a serial review and approval process is an outdated approach—and it’s time consuming. There are weaknesses in collaborative authoring and review (both internally and externally); thus, authors work outside the system until the documents are near final.

• The systems can’t be accessed globally, which further inhibits flexible collaboration.

• The systems lack scalability to handle the large volumes of documents, as well as the performance to provide instantaneous responses.

• They lack support for planning or timely insight into the status of necessary, approved documents.

• There’s no traceable history of actions on each document, including electronic signatures, or traceable references to where content is used in other documents (for example, to facilitate impact analyses).

• The systems can’t be easily adjusted in response to business changes.

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ENVISIONING A BETTER WAY It’s clear that life sciences companies need an approach that enables regulatory professionals to streamline, standardize and make transparent how authoring and submissions work gets done. The right approach will make it easy for you to answer fundamental questions such as:

• How do we manage knowledge so people can find and leverage previous work and readily execute next steps in the regulatory submissions process?

• How do we shave time off the document authoring and approval process?

• How can we collaborate faster and more efficiently, both internally and with external partners —while reducing errors?

• How can we better guide and assist those participating in the process on an infrequent basis to reduce errors, increase efficiency and streamline how work is done?

• How can we gain full transparency into the status of submissions authoring, review and approvals so we always know where we stand?

• As regulatory requirements for different markets change, how can we ensure that submissions are fully complete, accurate and compliant?

But from a functional perspective, what’s needed to make transformational change? What innovations and new thinking are required?

As a leader in enterprise content management for the life sciences industry for more than 20 years, EMC offers a unique perspective on the current trends and demands you face. We’ve talked with R&D professionals at all levels to understand their challenges. Our findings clearly indicate that life sciences companies are ready to embrace the following key concepts.

A UNIFIED DOCUMENT REPOSITORY Submissions can involve the orchestration of millions of documents across a number of products—a tremendous challenge that’s made even more difficult when organizations store documents in different systems, repositories and formats, both electronic and paper. Without a way to link content across these systems for consistent, simplified document management and user access, it’s difficult for authors to find and collect submission-ready documentation, or to manage an efficient review and approval process.

Complicating matters further is the fact that authors must be able to find and search through work that has already been done by themselves or others at some point in the past, leveraging or repurposing it to avoid rework and oversights. For example, sometimes clinical studies are put on hold, only to restart years later after applying new scientific learning. Given the number of documents, sites and people involved, even the most talented professionals will find it difficult to resurrect this work.

What’s needed is a robust content repository for managing all documents. A unified repository helps you maintain compliance with regulatory requirements—for instance, by making it easier to plan, track, maintain and assemble submission-related documentation faster and more accurately. This “single source of truth” should also make documents visible, searchable and readily accessible, regardless of where they reside.

STRUCTURED TEMPLATES, BEST PRACTICES AND REFERENCE MODELS Today’s R&D professionals need to work with a simplified, streamlined user experience that empowers even periodic and infrequent users to work like experts.

For example, rather than asking authors to manually create documents from scratch, companies should support authors by offering a template-based process. This way, authors can select from a predefined inventory of the most current, industry-standard documents, as well as search across the repository to leverage content created earlier or by others. Reusable templates can also be used to automatically structure documents based on

regulatory requirements for the country or region where drug approval is being sought, as well as to populate document properties and automate file placement based on industry-created reference models.

Used effectively, structured templates can increase productivity, reduce effort and ensure that documents are submission ready, complete with all required content elements. And when they are based on industry-standard dictionaries, taxonomies and object models, templates can also help eliminate redundant document and data entry, improve accuracy and help ensure that authoring is compliant with these resources. Examples include the Drug Information Association (DIA) Electronic Document Management (EDM) reference model and the International Committee on Harmonization Common Technical Document (ICH CTD) formats.

Process supports like these improve author productivity, save time, and reduce errors and omissions in documents and submissions.

WORKFLOW-DRIVEN COLLABORATION FOR AUTHORING, REVIEWS AND APPROVALS Collaboration is top of mind for life sciences companies today. Within R&D, cost pressures are driving life sciences organizations to collaborate more efficiently internally, and to work more extensively with third parties such as contract research organizations (CROs) and manufacturers to execute key business processes.

But collaboration is only a buzzword when people involved in submissions authoring and management are working across organizational and geographical boundaries without the proper tools. Many businesses still work primarily through email—a time-consuming, fault-prone method that limits visibility and lacks proper security for intellectual property. Document review and approval processes managed through email or other linear collaboration systems are cumbersome and inefficient. Reviews are often slow because only one person at a time can review, comment on and approve documents.

True collaboration can also be out of reach because companies lack centralized visibility into the work of external partners, such as the status of R&D projects and manufacturing details needed for compliance purposes. At the same time, many systems don’t make it easy for primary authors to see who has reviewed documents (and when), and who has signed off on them, to help authors track progress and finalize documents with confidence. When documents are circulated using email or other methods outside the system, the audit trail is incomplete.

For these reasons, life sciences companies need to drive new efficiencies in document authoring, review and approval processes. For example, they need to consider an R&D solution that transforms the process of authoring submission documents—including all reviews, approvals, changes, edits and updates—into a highly efficient, workflow-driven process. Workflows can not only guide authors through the content development process, but also push documents to the right collaborators and reviewers at just the right time.

Equally important, an R&D solution should allow multiple contributors to make edits, changes and/or annotations to documents in parallel, rather than sequentially, for much faster document creation and review. Ideally, the primary author should be able to easily merge all comments into a single document and then review, accept or reject edits, as appropriate.

These types of incredibly powerful, yet simple innovations can facilitate an expedited authoring, review and approval processes.

EFFICIENT DOCUMENT MANAGEMENT FOR FASTER, EASIER SEARCH The complexity and scale of the information required for new-product applications and submissions seems boundless today. Regulators demand that you include everything from data about nonclinical and clinical trials, raw materials and manufacturing processes, to information about products, worker safety experience and labeling—and that’s just to start. Adding to this complexity is:

• The sheer number of documents and interactions that must be managed across different systems and geographies

• The vast network of geographically distributed vendors, employees, test sites and departments involved in creating and sharing most documents

• The fact that many business processes are also being virtualized or wholly outsourced to CROs

In short, R&D solutions will need to make it faster and easier for authors and submissions professionals to find and search through documents. By streamlining the planning, tracking and maintenance of submission-related documentation, the right R&D solution can enable submissions to be orchestrated faster, and always based on the most authoritative sources. Predefined registration forms for different key topics such as product, as well as a preconfigured document inventory based on industry standards, can dramatically reduce repetitive, error-prone manual effort. These types of process supports help even the most experienced submissions professionals ensure that all documents are submission ready—and that submissions packages include all required content elements.

At the same time, companies need to support professionals’ demanding search, navigation and browsing requirements. For example, authors should be able to search archives and documents across the repository, efficiently leveraging prior effort to avoid costly rework and wasted time. And once documents are finalized, submissions professionals need fast, intuitive document search and retrieval tools for quicker submission assembly. This can be enabled by an R&D solution that offers faceted navigation based on ICH CTD standards and automatically reduces the document lists shown to users based on the categories they select.

And finally, submissions professionals need centralized visibility into the status of reviews, approvals, versions and more. This visibility should even be extended to include collaborative work with external partners.

The ultimate goal is to enable comprehensive lifecycle management and version control for all research and development documents and records.

ENTERPRISE MOBILITY Executives within life sciences companies are increasingly aware of the ways mobile technology can boost operational effectiveness and reduce costs. For example, some pharmaceutical companies are using tablets to provide standard operating procedures (SOPs) on the manufacturing floor, as well as to give people convenient, secure access to controlled documents and workflow tasks to accelerate processes.

But most R&D systems are unable to take advantage of mobile devices used among consumers and workers. Their core functionality simply wasn’t designed to translate into a mobile-friendly experience, which prevents everyone involved in R&D from keeping processes and document sharing moving while on the go. This, in turn, slows down submissions.

There is no question that use of mobile devices will become pervasive for contributors, reviewers and approvers of documents, complete with interfaces focused on the specific tasks of users. Authors will need mobile-friendly tools with an intuitive interface that allows them to participate in workflows by reviewing, approving and authoring documents while on the go. These tools should require little training to achieve competency and provide secure, role-based access to controlled documents without complex sign-on requirements.

Developers of R&D-related software functionality will also need to provide user interfaces optimized for different browsers as well as tablets and smartphones.

AGILITY In truth, most traditional R&D systems are rigid and ill-equipped to handle the changes facing life sciences companies today. Making adjustments involves customizations or changes to core system code. For even a simple change to an existing one (even something as small as the addition of a new tab), you may need to revalidate your entire system, a process that can add many months to a market launch.

In addition, regulatory requirements vary by country and region and are prone to constant change. Simply staying on top of these changes is a huge challenge. And noncompliance can result in “failure to file” for submissions, “findings” during audits and inspections, and even large fines and facility shut-downs if deadlines to address findings aren’t met.

The fact is, every business needs to make changes to its R&D system at one time or another, and these changes should not lead to significant delays and costs. You should be able to make small system changes via configurations rather than software changes, with automated documentation of the delta between the old and the new software configuration. Each company would have to evaluate their requirements on how configuration changes need to be validated, but overall, working from the delta changes should reduce the effort associated with making changes.

BROADENING THE VISION Our goal has been to provide thought-provoking ideas about how companies can take a new approach to facilitating the planning, authoring, review and approval of regulatory submissions documents. However, we have described but a small part of the overall, end-to-end process stream. Going forward, EMC envisions that R&D solutions will continue to evolve and provide comprehensive, integrated features that can greatly improve effectiveness and business value within your organization.

EMC DOCUMENTUM FOR LIFE SCIENCES For over 20 years, EMC Documentum has helped life sciences organizations meet compliance requirements, increase productivity and securely collaborate across the extended enterprise. For additional information about EMC Documentum for Life Sciences solutions please visit www.emc.com/documentumforlifesciences.

EMC2, EMC, the EMC logo, and Documentum are registered trademarks or trademarks of EMC Corporation in the United States and other countries. © Copyright 2014 EMC Corporation. All rights reserved. Published in the USA. 03/14 EMC Perspective H12993. EMC believes the information in this document is accurate as of its publication date. The information is subject to change without notice.

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