Regulatory Articles
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How Digitization Is Delivering Competitive Advantage In Device Assembly
9/20/2021
Data and the digitization of assembly equipment work to deliver a competitive advantage to pharma partners in terms of quality, continuous improvement, de-risking maintenance, and change management.
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Common Reasons For FDA Form 483 Observations And Warning Letters In Medical Device Environments
8/31/2021
By understanding the FDA’s updated approach to medical device regulation and the information provided in the inspection observations document, medical device companies can more easily identify and mitigate compliance issues.
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ISO 13485 - Change? Do I Have To??
8/31/2021
Accordingly, many companies have a conundrum if they want to maintain both ISO 9001 and ISO 13485 certification: How to comply with the varied requirements within only one quality system. The array of opportunity may not be as broad in terms of rationalizing how to do business as an outlier.
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Annex 11: The EU’s New Expectations For Regulated Computerized Systems
8/27/2021
The Annex 11 Guidance is for the lifecycle of computerized systems to reflect the increased use and complexity of automated systems in the pharmaceutical industry. In this paper we cover the Scope of Annex 11, it's impact on medical device companies and its role in inspection readiness.
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21 CFR Part 11 — Are You Ready For An FDA Inspection?
8/27/2021
Part 11 has been scrutinized and criticized over the years, but it remains in effect today. Given the pervasive automation of processes and digitization of data today, the regulation is more relevant than ever. In this paper we break down what Part 11 means and how to get inspection ready.
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21 CFR Part 11: Risks Of Noncompliance
8/27/2021
In a recent FDA Guidance for Industry: Part 11, the message is clear: compliance to the underlying predicate rules remains critical; the FDA will enforce predicate requirements for records subject to Part 11.
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Most Common Reasons For FDA Form 483 Observations And Warning Letters In Medical Device Environments
8/26/2021
When the FDA conducts regulatory inspections, issues that are considered objectionable conditions or compliance violations by FDA inspectors are itemized in a Form 483 or a warning letter. In this article, we help you understand the FDA’s updated approach to medical device regulation and provide information about inspection observations so you identify and mitigate compliance issues more easily.
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Automating Document Control Processes To Comply With FDA And ISO Requirements
8/25/2021
Your document control system should be agile and scalable to keep up with the changing regulatory landscape. Here, we detail the guidelines and standards that apply, and illustrate how digitizing document control processes is essential for ongoing compliance.
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Meeting Quality Standards With Multiple Global Manufacturing Locations
8/25/2021
With 66 global locations from Kansas to Krakow, Fagron needed a way to ensure each facility could stay in compliance with the regulations of every market they serve. The variety of processing by regulating authorities based on the country led to inconsistent processes. By implementing a software solution the team has reduced over 450 hours per year spent on preparing paper-based training materials, saving more than 500 sheets of paper per week at those sites.
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EU MDR: How To Prepare for The Upcoming Changes In Regulation
8/24/2021
Recognizing the need to enforce heightened safety measures and risk management processes, the European Parliament and the Council of the European Union developed the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) in 2017.