Regulatory Articles

1. The Search For Control: Total Quality In Life Sciences 2/18/2022

   Bring data into one place to gain end-to-end visibility and traceability for total quality in every stage of research, development and manufacturing.

2. How Effective Training Management Can Help You Prevent Quality Issues 1/28/2022

   Training defines the quality of the single most important asset of your organization: your employees. A good training management process serves as a preventative measure against poor quality.

3. Medtech Manufacturing: From Disruption To Evolution 12/16/2021

   Medical device manufacturing is a complex industry, so figuring out what areas to digitize can be difficult and different for every company. Here we explore different ways medical device and diagnostic manufacturers are embracing digital tools to maximize the value of ever-increasing data, as the industry pivots from crisis mode to evolution.

4. Vital Signs Of The Medical Device Industry 10/1/2021

   The medical device industry emerged from 2020 a little beat up and bruised, but those that were able to adapt successfully will act as models for 2021 and beyond. As the medtech ecosystem and medical device regulations continue to evolve in conjunction with the continued pressure to meet demand while adhering to quality expectations, medical device companies must embrace digital transformation and shifts in mindset to remain competitive.

5. Why Automation Is Essential For Document Control Compliance 10/1/2021

   In medical device development, speed, efficiency, and accuracy with document control processes are a top priority.  Regulators are embracing advancing technologies to effectively achieve their mission of ensuring public health and safety — including enhancements directly related to documentation.

6. Identifying And Preventing Common Data Integrity Issues 9/30/2021

   Data integrity plays a key role in all areas of CGMP compliance, and the FDA expects all data to be reliable and accurate.  A good approach to achieving and maintaining data integrity compliance is to develop a practical data management strategy that involves employees, IT data management processes, and company policies.

7. 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.

8. 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.

9. 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.

10. 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.