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.
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.
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.
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.
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.
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.
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
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
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
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.