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Optimizing regulatory submission processing to increase revenue through improved speed-to-market
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Learn about the submission process using Adlib ExpressMost of the world’s largest medical device companies use Adlib software to eliminate time-consuming and error-prone PDF creation tasks while delivering flawlessly formatted PDFs that meet the most demanding regulatory standards.
Adlib enables companies to reduce costs and save time in a variety of ways including preparing submissions for regulatory purposes, creating manufacturing documents (such as Standard Operating Procedures (SOPs) and work instructions) and enabling the effective management of important product design information.
Preparation of PDF Documents for Regulatory Bodies
Preparing PDF documents for submission to regulatory bodies can be complex and time-consuming, and in many cases, the formatting and quality checking is done manually. Medical device firms often rely on printed copies of high quality electronic PDF documents to complete their submissions. Whether submitting information on paper or electronically, medical device companies have simplified document preparation, improved document quality and therefore reduced document QA time from hours to literally minutes with Adlib Express, dramatically reducing costs, speeding up document preparation and ensuring the highest quality renditions.
Standard Operating Procedures and Manufacturing Work Instructions
Another challenge faced by Medical Device companies is in the preparation and use of various documents in the manufacturing environment. Standard Operating Procedures (SOPs) for example, can be complex to prepare, distribute for approval and print for use. Manufacturing work instructions present many of the same challenges as SOPs, requiring attention to detail in terms of formatting, approval and expiration control for printed documents to ensure full regulatory compliance. Adlib Express provides a powerful and scalable architecture which easily handles all of the complexities associated with creating PDFs used in managing SOPs and manufacturing work instructions. Complexities include maintaining strict PDF standards such as high-quality conversion to hyperlinked and bookmarked PDF from multiple source formats, merging and volumization, dynamic stamping, auto-generated Tables of Contents, configurable page-formatting, and much more.
Preparing for the future: eMDR
Medical Device Reporting (MDR) is a process that is evolving toward becoming more electronic. The new eMDR is a process where adverse event reports can be submitted electronically. Adlib Software helps Medical Device companies prepare for eMDR by automating the creation of high quality, submission-ready PDF’s, complete with page numbers and other dynamically generated stamps such as headers and footers. The result is that the Medical Device companies are cost efficiently meeting their quality obligations for electronic submissions.
Repurposing of Information through easy access to Design History Files
Often a large part of a Medical Device company’s design process includes a Design History File (DHF). The DHF is a file created and maintained for each new development project. This file demonstrates that the device was developed in accordance with the design plan, requirements, and the established Design Control Standard Operating Procedures. Products developed years ago or that become available through acquisition have DHFs that are often in paper format. DHFs have the ability to be leveraged for newer products and, when repurposed for a newer version of a product, the content can prove to be very valuable. These documents are a key element to the overall body of the content associated with a device and must remain accessible for the life of the product.
When left in a paper format, the legacy design history and quality documents are essentially useless. Re-creating content instead of re-purposing legacy DHF costs a company time which translates into lost market opportunity. Time is also lost when users are forced to manually search through paper archives or scan legacy DHP documents using imaging software. Creating non-text-searchable scanned images only achieves part of the intended goal - reducing storage space.
Adlib’s technology helps companies to turn historical, paper based DHF content into searchable, indexable content that can save an organization hundreds of man-hours. Adlib automatically turns scanned images into searchable, re-usable PDF or Text content. Adlib understands that it is not only important to make documents searchable, but to also ensure that the original context of the information is not lost. Adlib maintains the original image as the viewable, printable layer while providing searchable text within the same file as a background layer.
Accelerating processes in the Medical Device Industry
In summary, Adlib Express has helped large and medium sized medical device companies around the world in a number of mission critical applications, including:
- Reduced risk through the use of formatted PDF versions of Standard Operating Procedures (SOP) and manufacturing work instructions that can be shared electronically. This capability improves access to the proper version, reduces distribution costs and lowers the regulatory risk of drafts being mistaken for final documents.
- Reduced costs and improved user satisfaction by providing easy access to multiple document types as searchable PDF. Render a variety of documents throughout the lifecycle of the device including design documents, clinical study reports, adverse event reports and others.
- Ensure compliance through the effective storage of a common format, PDF, to meet the record archival and retention mandates in health care which extend beyond product lifecycle.
When it comes to streamlining document intensive processes throughout the extended enterprise, adhering to regulatory compliance standards or maintaining secure, accessible documents, Adlib is the leader in providing automated, centrally controlled, high-quality document to PDF rendering solutions for Medical Device firms.
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