The content and compliance issue

NGP. Regulatory and compliance pressures are increasing across all industries. How can document management help?
In today’s global workplace, it is increasingly difficult to separate regulatory and compliance issues from one and another. As the number of regulators and regulations increase, not only must companies deal with the traditional pharmaceutical issues around cGxP, but now the world of corporate governance and financial compliance as well as sales and marketing compliance must be addressed within the same framework.

Since many European life science companies do business in the United States, it is impossible to overlook the regulations placed upon companies by the US government, and starting this year, the new regulations imposed by the individual states themselves – like California and Vermont. If you sell a drug in California for instance, no matter where your company is based, you are subject to The California Marketing Compliance Law (CMCL).

The CMCL requires pharmaceutical companies and medical device manufacturers to adopt Comprehensive Compliance Programs (CCPs) that meet the standards published by the Department of Health and Human Services’ Office of Inspector General (OIG). The CMCL also requires companies to make certain declarations regarding compliance publicly; usually by means of content published on their website.

What all this means is that the need for an enterprise compliance content management system has never been greater. Not only must all content that represents the company (in a submission, on a website or handed out by a salesperson) undergo a review and approval cycle, but also much of it is subject to annual or bi-annual recertification and extensive ongoing training. This is in addition to the rigorous regulatory compliance oversight that is already in place for quality and manufacturing documents.

As areas such as off-label promotion receive greater attention from the regulators, the need to control and retain content becomes a vital part of maintaining both the public image and the integrity of your corporation. Not only should all documents be reviewed and approved in a formal collaborative environment, but special care needs to be paid to the post-approval lifecycle to ensure that the documents are available when required for regulatory examination or internal access. A validated, compliant content management system is the only way to fully address these pressures.

NGP. What kind of impact could improved content/document/digital asset management have on a life sciences enterprise? What are the business benefits of such a solution? And are these benefits the same for SMBs as they are for large corporations?
The benefits for small and medium organisations are in some ways even greater than they are for large corporations. Most large corporations deployed a first generation content management system several years ago, while smaller companies may still be paper based. In addition, smaller companies tend to be more virtual in nature, relying on outsourcing and third party relationships to manage the complete product lifecycle. As content moves between the sponsor organisation and outside parties, control becomes critical.

A compliant electronic system that provides version control, workflow, electronic approval and a secure audit trail at a minimum, can deliver large-scale performance benefits to any size organisation. A single, secure location where all internal and external authors, reviewers and approvers can access the current version of the content allows for the enforcement of authoring templates and assures that draft versions are always under the control of the system.

The business benefits of these systems are numerous, including greatly reduced review and approval time of critical policies and procedures and of submission content such as clinical study reports. All versions of all documents can be controlled by the system, preventing unauthorised distribution of a company’s intellectual property and enforcing the destruction of unwanted draft versions.

Additionally, the workflow that a system such as QDocCompliance from QUMAS delivers means that everyone who needs to review or approve a document prior to release will be included, and no document will be exposed to outside examination without proper approval.

This degree of full lifecycle management can have a major impact on the responsiveness and performance of any life science company. By embedding industry best practices into all our solutions, QUMAS delivers a complete level of confidence that you will be able to defend against the most intense regulatory scrutiny while at the same time enabling you to streamline your business processes and reduced exposure to risk.

NGP. A recent Forrester survey suggested a lack of understanding among executives about compliance issues. Why is it so important, now more than ever, that they comprehend the implications?
There is a definite change in the enforcement climate today, starting with the US, and spreading around the globe. An increasing number of agencies, such as the US Department of Justice (DOJ) and the Department of Health and Human Services (HHS) are greatly expanding their enforcement activities in the life sciences sector with currently over 150 European and US companies and 500 drugs under investigation. It is estimated that based upon the current rate of fines levied, this represents around US$30 billion in criminal and civil damages, and the penalties usually include limiting the company’s right to sell into certain countries. The effects of these proceedings can be devastating to a company’s long-term survival.

In today’s climate, it is vital that a company’s executive management team understands the need to have an enterprise-wide compliance management system in place before the investigators knock on the door. The best defense against any action, including unintended actions and those of rogue employees, is to have a compliance program already in place to catch and correct those actions as soon as possible. A full compliance program, one that controls the policies, enforces training, monitors and audits the actions of the organisation and its agents and can report on those events to senior management is required in today’s world.

A system like the QCompliance Suite from QUMAS can provide a complete solution in all three areas. QDocCompliance controls, maintains and enforces training on all relevant documents, QProcessCompliance monitors how well your company is doing in following these policies and procedures, and QPortal provides management oversight and reporting. With these systems in place, you have gone a long way toward eliminating your compliance risk and reducing the long-term damages in the event of unintended activities.

NGP. And what trends/developments do you expect to see in this market over the next few years?
Going back to the first question, one of the major changes that industry is facing is the convergence of regulatory compliance with general corporate governance as the industry moves toward a commonality-of-compliance approach across all areas of the enterprise. The single-point approach to individual requirements has already proven to be much too costly and counter productive to continue. The idea of identifying, selecting, purchasing, implementing, configuring and training on a solution for each new regulation that is enacted quickly becomes unworkable and unaffordable.

When you add the fact that complying with these regulations is never limited to a single department within the enterprise, but crosses departments and divisions, a top down, configurable compliance framework is the only reliable method of achieving sustainable corporate level compliance. A complete compliance program, starting with content management at its core, delivers both the level of assurance the regulators require and the performance improvements your stakeholders expect.

Kevin O'Leary has been with QUMAS since its inception and was responsible for the original design and development of the company’s first product releases. Kevin has worked within regulated industries since 1987 and has an extensive knowledge of regulatory compliance solutions.

He established QUMAS’ presence in the United States in 1997 and now serves as the company’s President and Chief Marketing Officer.

Having originally majored in Computer Science, Kevin pursued further studies in industrial management and now works closely with regulators and industry organisations to ensure that QUMAS’ solutions meet the compliance needs of regulated companies.