Nicotinamide Mononucleotide (NMN) has been making waves in the world of dietary supplements. Touted as a potential fountain of youth and an elixir for longevity, NMN supplements have gained popularity among health enthusiasts. However, there's a catch: the Food and Drug Administration (FDA) has imposed restrictions on NMN dietary supplements, including FDA-approved food supplements. But why?
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 the pharmaceutical industry, adhering to Chemistry, Manufacturing, and Controls (CMC) requirements is paramount for ensuring the safety and efficacy of drugs. However, Regulatory agencies often identify gaps or deficiencies in the CMC data submitted by companies, which necessitates remediation.
This blog explains the indispensable role of Regulatory staffing solutions in successfully navigating CMC remediation while also shedding light on effective portfolio management practices.
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.
Validation protocol is defined as a documented plan for testing a medical device to confirm that the production process used to manufacture the product meets the specific user, technical, and Regulatory requirements. This includes a review of process variables and operational limitations and the analysis of test results under actual use conditions.
The validation process involves several tangible actions. The steps are elucidated as follows:
Abbreviated SmPCs (Summary of Product Characteristics) form an important source of information for healthcare professionals and patients alike. These documents provide a summary of key information about a medicinal product, including its indications, posology, contraindications, and adverse reactions.
An operation manual is in many ways referred to as labeling, Instructions for Use (IFU), or a user guide. It is a document that is instrumental in achieving the safety of a medical device and illustrates the general ways to use or operate a medical device.
Label maintenance and updating is the process of ensuring that the data on the label stays up-to-date and accurate throughout the life cycle of the device. This could entail updating information to meet new laws or standards, amending the existing labels to reflect changes in the product or its intended use, or fixing typographical errors.