Accelerate Your Records Management Program

Download PDF

Introduction

The development and manufacturing of pharmaceuticals and medical devices are governed by a wide range of regulations globally, including patent law, electronic signature laws, good lab practices, good clinical practices, and patient privacy and consent laws. Because of these regulations, pharmaceutical and medical device companies must keep extensive records of their research and manufacturing processes. Some of these records may be needed urgently in the case of a regulatory audit or legal discovery request.

However, multiple storage locations and, in some cases, different records management policies across regions or business units can delay record retrieval. While almost all companies have records and information management (RIM) policies, employees may not fully understand or consistently implement them. Having the right information at the right time is critical to comply with regulations and protect intellectual property (IP), yet records are often dispersed across disparate locations. This makes it exceedingly difficult for product development and legal/regulatory teams to find information when they need it.

According to research from Iron Mountain, 80 percent of companies have formal RIM policies in place, but only 37 percent say those policies are consistently applied across the company. What’s more, 74 percent of companies say they do not audit their programs for compliance or do so only on an ad hoc basis. In the case of patent litigation, biotechnology and pharmaceutical companies are second only to consumer products in the number of cases each year.

Why is this important for pharmaceutical and medical device business leaders today? Knowing that comprehensive RIM policies are in place and implemented consistently across the organization mitigates risk and improves efficiency. Pharmaceutical and medical devices companies regularly in-license patented technologies and in turn, license their compounds and technologies to business partners. Managing records with consistent retention and destruction processes, consolidation, and metadata indexing protects IP and supports the licensing process. In order to meet both risk mitigation and product development goals, these companies need a records management system implemented consistently across their organizations, and their staff needs effective training on how to appropriately manage records in accordance with their RIM system.

Today’s Challenges

High Industry Standards

The pharmaceutical, medical device, and other life sciences industries maintain high standards for records retention both as an industry and in response to regulations that may change over time. Individual companies may not have tools in place to measure how consistently staff implement RIM and whether the system allows timely and secure retrieval of vital documents. Benchmarks are needed to set and achieve meaningful RIM goals.

Global Regulation

Complying with regulations across international business units can be complicated. Documents no longer needed in one jurisdiction may still need to be kept for another regulatory agency. A successful RIM program must track requirements globally for all business units and ensure compliance through consistent implementation.

Mix of Vital and Ordinary Records

With strict industry and government standards for maintaining research and manufacturing records, life sciences companies may simply “keep everything.” The problem with this seemingly “safe” strategy is that documents needed for legal defense of intellectual property or responses to regulators may be difficult to find among other less vital records. In addition, some regions require that patient records from clinical trials be destroyed after certain time frames. In order to retain and destroy clinical trial documents in compliance with global regulations, companies need a RIM program that tracks these legal retention schedules.

Fragmented Storage

Divisions generate their own records, which can result in fragmented records generated with different standards. Growth through mergers and acquisitions can also result in a network of documents managed with inconsistent storage practices. It is not uncommon for organizations to acquire physical records without sufficient indexing, and these records are often kept in case they contain vital product development and manufacturing information. While it is a product of global success, this variety of RIM systems makes it difficult to design, implement, and train stakeholders to maintain a consistent, secure and efficient program.

Insufficient Indexing

Because of the sheer volume of records generated in product development and manufacturing, consistent indexing is needed to create high-quality metadata. Balancing quick access to records across the organization with securing proprietary information requires capturing a standard set of data that can then be searched efficiently.

Inconsistent Implementation

While most organizations have records management policies, individual divisions may not be implementing them consistently. This may be because of lack of training or limited resources, including limited staff time and a lack of RIM training. Sometimes these inconsistencies are not identified until records are needed urgently by product development, regulatory, or legal teams.

Typical Approach

If you look at real-world examples, you can see where organizations can achieve significant business value by accelerating their RIM programs.

In one example, Iron Mountain helped a nutritional supplements company create and implement an efficient RIM system not only for their manufacturing paper records, but for product samples as well. The company went from retaining a large number of records and product samples that were not categorized to a RIM program that categorized records and product samples and established a retention schedule to comply with both regulations and internal protocols. Iron Mountain also conducted a records management risk assessment that identified 25 potential areas of vulnerability. By developing a records retention schedule and an indexing system to classify and categorize records, and training employees to use it, Iron Mountain helped the company both mitigate risks and increase productivity.

Reframing the Challenge

Accelerating your RIM program is an opportunity to manage risk, improve productivity, reduce costs, and enable the organization to respond more quickly and efficiently to intellectual property and regulatory requests. So, the challenge can be reframed as follows:

  • Benchmark your current RIM policies and review how effectively and consistently they are implemented across your business units.
  • Implement consistent records indexing, management, and storage across departments, globally.
  • Create and maintain a records retention schedule and classification scheme that will be available globally. This successful approach to RIM will allow all teams to quickly locate and securely store vital documents and appropriately destroy records meeting retention requirements.
  • Train key personnel on the RIM system so that your records are managed in accordance with your retention schedule and information management policies. Supplement your staff with knowledgeable RIM industry experts to help implement your RIM solutions.
  • Implement legal hold tools that identify vital records needed to move product development forward, protect intellectual property and help you comply with regulations. Be prepared to respond to business opportunities and legal requests quickly and accurately.
  • Analyze metadata to accurately classify documents and standardize records retention and destruction processes, helping you achieve research and development productivity gains and faster response times to regulatory legal documentation requests.
  • Provide metrics and monitor compliance to meet regulatory requirements and be ready to respond to internal and regulatory audits. Ensure your company is follows industry best practices in RIM.

Driving Business Value

Accelerating your RIM program provides many benefits, including:

  • Risk Mitigation:

    Litigation over intellectual property and responding to regulatory audits can be time consuming and expensive. Consistently implemented RIM programs reduce the time spent responding to legal and regulatory issues and quick responses to regulators reflect positively on your company
  • Increased Efficiency:

    By managing all records consistently, teams can work together seamlessly, enhancing collaboration across groups and divisions globally. When the RIM program is clearly defined and employees are trained to implement and follow it, the time spent retrieving records is reduced.
  • Continuous Improvement:

    Identifying areas of potential risk helps design a RIM program that provides protection and efficiency. Managing retention and destruction schedules and implementing tools to measure RIM implementation across all business units helps ensure that RIM best practices are followed and improved upon.

Conclusion

As with many of the challenges facing business leaders today, RIM policies may be defined but not implemented consistently across global organizations. Individual divisions may not have the budget, staff, or necessary training allocated to execute RIM sufficiently. A records management risk assessment will identify potential risks so RIM policies can be improved to mitigate them. Assessing the needs of product and business development teams to access vital records for licensing can help establish the necessary secure-access turnaround times for vital documents. Professional training and utilizing RIM advisors empowers your company to implement and execute RIM consistently across all business units. Fortunately, there are vendors that have significant expertise and experience in assessing, designing, and implementing RIM programs.