January 31, 2023

Instructions for Use (IFU) creation in Pharma & Life Sciences

image shows researchers creating instructions for use

Labeling requirements, such as IFU (Instructions for Use), product labeling, and manuals provide step-by-step instructions on how to use everything from medical devices to prescriptions. To reduce risk, meet standards, and speed up development, companies need new technologies and processes. Having a Component Content Management System (CCMS) in place allows cross-functional collaboration, compliance with regulations, and quick updates – all of which are key components of product and labeling documentation.

A Component Content Management System platform makes it easy to manage and track all documentation requirements

When it comes to Instructions for Use and documentation, nothing is more time-consuming than having to use an old system. Many Medical Devices and Pharma organizations tend to rely on a legacy-based system to extract content, which takes up a huge amount of time. Having to search for the latest content that needs updating – in pdfs that may be stored in a variety of folders, or even a paper-based filing system – is not viable. A cloud-based solution, like the Paligo CCMS, makes it easy to produce content in a fraction of the time it takes to extract it from legacy systems.

Many medical organizations have already begun updating their systems ahead of the new European Medicines Agency (EMA)’s device regulations. In turn, pharmaceutical companies submitting a new drug application (NDA) or a biologics license application (BLA) will have to adhere to recent updates in the FDA’s Instructions for Use document for Human Prescription Drug and Biological Products

Using an efficient CCMS platform makes it much easier to adapt to such regulatory changes quickly. By unifying all labeling and IFU (Instructions for Use) content in a single solution, teams can operate from a single source of truth that gives full traceability and accountability. And because everyone is working from the same set of data, teams avoid unwanted changes.

Time-saving CCMS software keeps up with multiple market requirements

Different markets have different regulatory requirements for medical devices, not to mention labeling and guidelines for pharmaceuticals. For example, the FDA has different requirements than the EU. There are also international standards, such as the International Organization for Standardization (ISO), with which medical device manufacturers must comply. ISO standards are voluntary, but many countries require or recommend compliance.

Some specific medical devices are also subject to special regulations, such as the U.S. Federal Food, Drug, and Cosmetic Act (FFDCA) and the EU Medical Devices Directive (MDD). Also, changes to pharmaceutical regulations are commonplace, including updates on adverse effects, warnings, and more.

Following all of these different regulations can be a challenge for medical device manufacturers, pharmaceuticals, and life science companies in general. In this case, a Component Content Management System (CCMS) can help teams with the content management of pharma and medical equipment Instructions For Use (IFU), clinical evaluation reports (CER), and summaries of safety and clinical performance (SSCP). The Paligo CCMS allows you to create, update, translate and maintain these instructions and reports for multiple markets through intelligent content reuse features

How reusable components help speed up labeling and product documentation on Instructions for Use

The Paligo CCMS uses a structured authoring approach, with a topic-based open standard XML source format. Basically, it means controlling the content by pre-defined rules, ensuring both consistency and accuracy. The technical writer working on Instructions for Use or other labeling documentation can primarily focus on the content, instead of the styling or formatting.

One of the central ideas behind XML-based and topic-based authoring is to enable users to more easily organize, find, and access information through the reuse of content as building blocks. Paligo’s content reuse features allow you to use the same piece of content in multiple places, saving time and effort, for example safety content that may be shared across several products. 

Paligo’s structure and semantic tagging enables and simplifies content reuse, increasing consistency, accuracy, and efficiency in your documentation.

Collaboration on documentation is essential to following IFU requirements

To create safe and effective Instructions For Use (IFUs) for medical devices and pharmaceuticals, it is essential to have a strong and efficient collaboration between all departments involved. There are many different regulations that need to be considered, depending on the market. To follow IFU requirements, it’s necessary to coordinate with the Regulatory, Marketing, Legal, and Quality departments of your company.

Each department will have its own set of requirements and expectations regarding the types of Instructions For Use. For instance, the Regulatory department will need to make sure the IFUs are compliant with all the relevant regulations through clinical evaluations. Marketing will want to make sure all directions for use are clear and concise because they need to highlight the features and benefits of the product to appeal to potential customers. Legal needs to make sure that any product labels are free of false or misleading claims, while Quality needs to ensure any instruction manual accurately reflects the product’s design, and is up to date with any product changes.

With so many departments, all with specific needs, it’s important to have a single source of truth. Organizations using a comprehensive, centralized, cloud-based CCMS accomplish more efficient collaboration between all departments involved with single sourcing. Everyone is working from the same data, so the chances of errors reduce greatly, while documents remain consistent.

Updates in Instructions for Use (IFU) regulations

As anyone in the Medical Technology and Pharmaceutical industry knows, it is critical that information is accurate and up-to-date in product manuals and IFUs. For example, this article from Med-Tech News explains the impact the new European device regulations will have on companies over the next few years. Organizations will have to update their IFUs with “additional information and clarification, covering areas such as intended user, CMR/EDsubstances, implanted device, and an explanation of the new label symbols”.

Unfortunately, with the vast number of documents and the rate of change, these updates are difficult to manage in older systems. Information may be located across departments in a number of folders or separate databases. However, companies that have adopted a component content management approach can manage large and complex documentation sets while allowing for easy updates – in a significantly less amount of time.

Additionally, when using a CCMS, teams can manage a wide array of different types of content including text, images, presentations, podcasts/audio, and videos. The system includes a central repository for tracking and storing content. Plus, the repository is easily searchable so that users can find exactly the information they need. 

One of the advantages to Paligo is that it stores a record of your content each time it’s saved. Therefore, an audit trail of your content is always available. You can see changes that have been made, as well as when they were made and by whom. This lets you compare previous versions to the latest version, which is necessary for traceability and preventing unwanted changes.

With a Component Content Management System, ensuring product manuals are accurate and up-to-date is greatly simplified.

Summing up the benefits of using a CCMS to create Instructions For Use for Pharmaceuticals, Medical Devices and Technology

  • Enabling improved compliance with regulatory requirements
  • Reduced time and costs associated with creating and maintaining IFUs
  • The ability to create IFUs in multiple languages for multiple markets
  • Easy and quick updates to IFUs
  • Audit trail to track and manage changes (including who made them and when) to IFUs
  • Version management to keeps track of all versions
  • Ability to publish different variants of the content from a single source to different markets, regional regulatory requirements, products, etc.

Let the Paligo Component Content Management System (CCMS) simplify your Instructions for Use

As stated above, there are many reasons to consider using a Component Content Management System (CCMS) if you work in the Medical Technology or Pharmaceutical industry producing IFU documents. Many companies are turning to CCMS software in regulated industries where compliance is paramount. This type of system facilitates cross-functional collaboration between different teams who need to work on updates to the same content as new information emerges.

In the Life Sciences industry, new developments can have a major impact on patient safety. A CCMS can help you manage the huge amount and complexity of content that is often required for documentation. And in this industry, where global reach is essential, the Paligo CCMS will make it easier to both adapt to regional regulatory differences, as well as simplify the management of translated content

If you’d like to learn about the benefits of the Paligo CCMS for Pharma, Med Tech and Life Sciences, you can find out more here. A modern cloud-based CCMS can help you meet compliance requirements, manage large volumes of content, and collaborate effectively with other teams.

It’s time to improve the way you work!