Freyr Solutions

In today's digital era, data security and compliance are more than just buzzwords-they are critical components of success for any organization, especially in sectors such as life sciences, pharmaceuticals, medical devices, and similar fields. Regulatory compliance is a complex landscape, and with the increasing reliance on software and technology, it becomes paramount to understand why data security and choosing compliant software are essential.

In today's heavily regulated business environment, compliance with 21 CFR Part 11 is mandatory for companies within FDA-regulated industries utilizing electronic records and signatures, notably in the Life Sciences sector encompassing pharmaceuticals, biotechnology, CROs, and related fields. Non-compliance can lead to Regulatory repercussions, including warnings, fines, and other enforcement actions. This is where Audit Trails in the Regulatory Document Management System (RDMS) come into play.

In today's world, businesses in regulated industries like healthcare and life sciences need to follow compliance with industry-specific regulations. Regulatory documents serve as vital communication tools with governing authorities, demonstrating adherence to guidelines, ensuring public safety, and supporting critical business decisions. However, managing these documents efficiently and accurately can be an overwhelming task. Regulatory Document Management Software (RDMS) offers numerous benefits that can significantly improve an organization's Regulatory document processes.

In today's highly regulated business landscape, organizations face the formidable challenge of managing an ever-growing volume of documents to ensure Regulatory compliance with diverse standards and regulations. To navigate through complexities such as document overload, compliance costs, increased audit scrutiny, etc., many businesses are adopting Regulatory Document Management Systems (RDMS). This blog explores how RDMS can streamline compliance efforts, improve productivity, and reduce risks, ultimately driving organizational efficiency.

Since 2003, eCTD has been accepted by several Health Authorities around the world. Its standard has evolved incrementally over time. Based on the Health Level Seven (HL7) standard called RPS (Regulated Product Submission), eCTD 4.0 brings in major changes and introduces certain substantial updates. The updates focus on addressing a few key constraints that both Agencies and sponsors have discovered over the last two (02) decades.

Life sciences is a highly regulated industry, full of sensitive information that is required to be maintained efficiently. Documents are the backbone of any life sciences segment since it establishes the quality of processes and assurance of safety. The growing volume of documents in organizations exponentially increases the demand to replace traditional and manual documentation practices to reduce time, effort, and errors. In such scenarios, the absence of a proper Document Management System (DMS) increases the chance of misplacing critical documents and tracking changes significantly.

On July 28, 2022, the EMA released an incremental update to the IDMP-SPOR implementation guide (IG). The latest version, 2.1.1, addresses a few gaps in product data definition, including corrections and clarifications.

The new version enables web-based forms to replace the existing electronic application forms (eAF), making them more efficient. The web-based forms project is called DADI (Digital Application Dataset Integration), and its implementation is planned to start in October 2022 with an initial web form for variation procedures only.

Life science companies face massive challenges while constantly staying ahead of dynamic Health Authority (HA) updates. In addition, it requires multiple recurring and time-consuming processes. The traditional exercises are cumbersome and laborious, proving that Regulatory operations are costly, complicated, and slow. The ever-changing sphere of HA regulations makes it arduous to keep track and adapt at the same pace.

In addition to completing the requisite xEVMPD data submissions, life sciences organizations will now need to use a web-based application form called the Digital Application Dataset Integration (DADI). The European Medicines Agency (EMA) designed DADI as a long-term replacement for the PDF-based electronic Application Form (eAF), which was incepted to support eCTD submissions.