Each day, companies in the life sciences industry have to answer to regulatory authorities from around the world. Each product requires detailed, complex documents to authenticate and validate that the contents are safe for humans. The document requirements result in a tide of documents that a life sciences company has to push out with each product.
Manually compiling these documents come with many challenges, and the process is often time-consuming and tedious. Failing would means the company cannot send its products to market. Document management solutions have become a staple for the life sciences industry, and no matter how tedious or complicated it may be, it is necessary for companies to operate.
Thankfully, a better alternative to manual document management exists today.
Document automation tools are a way for life sciences companies to improve their document creation and publishing processes and get to its products to market faster by automatically organizing and compiling complex documentation.
Document automation applications such as those contained in the GCI product suite are a game-changer for the life sciences industry, helping them improve their efficiency, get to market faster, and with fewer errors. Let’s take a look at five ways document automation can help companies in the life sciences industry.
Creating complex documents involves searching for and finding specific documents from a document management system at best or from physical documents at worst. Even with sophisticated document management systems like OpenText Content Suite, this process is vulnerable to human error.
Skipping the correct files, selecting the wrong version of files, or not being able to find the correct files are all examples of human errors. Placing the right files in the correct order in the assembled document is the next challenge that needs to be overcome for the compiled document to be accepted.
Document automation solutions like GCI’s outline the documents you need based on which complex document you are trying to create. It then automatically finds the correct documents and puts them in the assigned order for the authority to approve. It then delivers them to a workflow that routes them for an initial review and compares the documents gathered to identify any files that are still missing.
This process eliminates human error on all aspects of complex document creation, ensuring that your submissions are always accurate, complete, and 100% correct.
The pharmaceutical and life sciences industry is extremely competitive, and getting one product to market faster than a competitor can mean the difference of millions of dollars. Once a product is fully developed and tested, the complex documentation requirements are one of the most time-consuming barriers to market entry for companies. We have all heard the expression, “if it’s not documented, it didn’t happen.” This phrase is the norm in the pharmaceutical and life sciences industries.
Locating the specific files within a content repository and ensuring that the files are up to date, reviewed, approved, and signed before submission could result in days, week, or even month-long delays.
With document automation, this process is trimmed down to a few clicks and approval processes. Electronic signatures can be added, and you add or adjust pagination, publishing, signing, and other options where necessary. You’ll also be able to change standard formatting variables, such as font, color, size, style, and the general layout and design, including headers, footers, chapters, tables of contents, and watermarks.
This enables you to get to market faster and more efficiently than competitors who still use manual document automation and publishing processes, potentially earning you thousands or hundreds of thousands of dollars.
Document automation and publishing processes can be very labor-intensive and expensive, given the documentation requirements for regulated content in the life sciences. Generating, Publishing, and retrieving documents demands focused attention and effort, resulting in hours and days of productivity that could be spent elsewhere.
Document automation handles these tasks so you can free up human resources around your organization to focus on tasks that are the highest and best use of their skills, instead of essential but tedious document creation and publishing processes.
Many complex documents require the inclusion of a multitude of different file formats and images that are often not easily accessed. This forces organizations to convert files one by one until they are of a uniform and easily accessed formats such as PDF.
Useful document automation tools enable you to collate and publish disparate files into a compiled document on demand. GCI’s document automation solution allows you to convert over 200 different file types into PDF and other formats such as DOCX and XML.
When dealing with multiple compiled documents for numerous products, this feature gives these organizations the power to save vast amounts of time and money, making them more productive.
Compiled documents are required to be submitted in a permanent format like PDF-A. Life sciences companies who provide compiled documents that are not in the correct format are simply not compliant in the eyes of the respective regulatory authority.
Document automation solutions keep up with the ISO standards for document formats for long-term storage. This gives peace of mind to organizations in an ever-changing regulatory environment.
The life sciences industry relies on sound document assembly and publishing processes to stay competitive. Automating these document processes can vastly improve how your organization handles these critical processes. In every aspect, document automation can increase your productivity and make your compiled documents more accurate, complete, and effective.
Global Cents offers document automation through their GCI PowerTools suite that includes a complete document management solution, from collection to publishing. If you would like to upgrade your document management process, visit GCI’s website today, or contact us.