As one of the most highly controlled industries, the Life Sciences sector is swathed in regulations regarding industry and international standards compliance. Highly enforced to both uphold quality practices and ensure the safety of millions of customers worldwide, these regulations are a fundamental component of the health and sustainability for people as well as industry.
For both regulatory and audit inspection purposes, many in the Life Sciences, including medical device manufacturers and biomedical and pharmaceutical companies integrate document management systems into their workflow to establish a paper trail, which systematically documents each step of development and progression throughout a product’s lifecycle. However, as electronic documents replace paper records in areas such as R&D, clinical trials, content development, laboratory practices, and manufacturing, it becomes difficult but especially necessary for companies to properly understand, manage, and control the flow of (digital) information.
The US Food and Drug Administration’s Code of Federal Regulations (CFR) Title 21 Part 11 mandates that digital records must have an electronic equivalent of a paper trail and includes strict criteria for both electronic documentation and signatures. Non-compliance can result in fines, product launch delays, additional costs, and most severely, the shutting down of operations.
The importance of having, tracking, and maintaining records is not only evident, but emphasized in these regulations; the same practice can also be applied to terminology, especially if product manuals and documentation need to be made world-ready for international distribution.
With their comprehensive tracking abilities, terminology management systems prove to be a valuable tool for companies in the Life Sciences industry. In addition to facilitating terminology accuracy and consistency, terminology management systems also categorize and track the creation, review, approval, storage, access, management, and retirement of each term. The ability to show details such as these (for instance, who made which alterations to a term and when) can serve as valuable confirmation to auditors in a compliance audit by supplying auxiliary safety measures in the digital paper trail structure.
Multilingual terminology management makes compliance with industry and international regulations and standards easier. With today’s advancing research and development, collaboration across multiple fields occurs more frequently. Similarly, terminology is also collaborative work, requiring individuals from many different disciplines to work together to ensure global consistency and conformity. Specifically within the Life Sciences industry, medical scientists, electronic engineers, marketing managers, technical writers, translators, and reviewers must all collaborate, often from different locations, to decide on accurate terminology translations. Ensuring global conformity and maintaining a certain standard across different institutions, businesses, and individuals around the world is extremely challenging, but not impossible.
Companies in these industries have strictly defined terminology requirements because these industry-specific terms have very precise, and therefore critical, roles in correctly portraying information—not only for product messaging, but also for accurate communication among and between R&D staff, global deployment teams, and, most crucially, customers. Misinterpreting a term can have a direct impact on safety and may lead to costly consequences.
Having a set of well-developed terminology to clearly and accurately define each important product component and application is critical for companies in the Life Sciences industry. Incorrect terminology not only leads to confusion and poor translations, it can have a direct impact on patient safety and may delay product launches due to non-compliance with international regulations. Despite the apparent importance of terminology management, many Life Sciences companies either lack a mature process that allows them to systematically manage product terminology or don’t manage their terminology at all. Indeed, many companies would fail an FDA audit today should they be audited on how terminology is created, reviewed, translated, and approved.
One typical example of this inattention to proper terminology management is when a company’s only source of “terminology management” is a spreadsheet, which doesn’t include the detailed definitions needed to explain what each term actually means. Even if a company manages to provide definitions, the terms are often saved in an offline, static file on a single employee’s hard drive; therefore, if a user modifies a term, others using the same database are not notified automatically, leading to inconsistency issues. More importantly, the lack of information regarding who approved the use of each term leads to little or no accountability; thus, the cycle continues. To avoid this, a history or audit trail should be maintained to display all changes, such as the creation, review, translation, and approval of each term.
The EU Commission Directive 2003/94/EC requires that health and medical device manufacturers establish, manage, and maintain electronic and paper documentation systems in a readable form, protected against damage or loss.
Terminology management will streamline your production process
Implementing a paper trail component into your internal company workflow not only adheres to industry regulations, it also generates value-added benefits, including
Additionally, paper-trail documentation also has the added bonus of tracking effective practices and revealing ineffective ones. By documenting and reviewing these paper trails, companies have the ability to enhance productivity and improve processes, thus facilitating further growth and development.
Even though effective and proactive terminology management comes with a great number of benefits in terms of improved quality, time and cost savings as well as global regulatory compliance, doing it right requires a collective and continuous effort. Terminology is a cross-functional issue and the costs of communication failures are often hidden and go un-owned, which is why it requires managerial and executive attention in order to undertake a more organized and focused approach.
To get started, you need to address three related areas:
Developing a company-specific business case (cost/benefit)
“Getting on your feet” and starting to make terminology management part of business-as-usual
Next, select a web-based terminology management system that is easy to implement and accessible from anywhere. As part of the regulatory requirements, the system must support detailed edit traceability, user management, version control, user discussions, and an automated workflow. In addition to these functions, you should also check the following:
No 3rd party software: having web access should be all that you need to harness the power of terminology management.
Scalability on-demand: adding users as you go, never overpay for something you don't need today.
No vendor lock-in: cancel anytime, don't get locked-in with complex software installations.
Remember that although the right tools are critical, success also requires the right people and processes, so you need to make sure important stake holders are aligned with your end goals. If needed, there are 3rd party consultants that are available to train your people on-site on the importance of company-wide terminology management and industry best practice.
The following diagram illustrates the process a terminology system, such as TermWiki Pro, can be integrated with a company’s existing content management workflow.
The end goal of implementing a terminology solution is to furnish a platform in which a company can both leverage existing multilingual content, and organize it within a framework that promotes the creation and ongoing collaborative development of new content. This will enable the company to achieve an optimal degree of consistency across documentation and languages, leading to considerable savings in both time and money, all the while ensuring compliance with global regulations.