Top 8 Change Management Tools

Change is inevitable for the Healthcare & Life Science (HLS) manufacturing industries, which are heavily regulated and frequently audited. Compliance managers, quality assurance, and quality management professionals for life science manufacturers may face many challenges in their quest to implement change.  Successfully navigating change management is especially nuanced for healthcare, life sciences, and medical device...

MDR: Maximizing Changes to Medical Device Reporting Regulations

Back in May, 2017, the EU Medical Device Regulation (MDR 2017/745) entered into force, replacing the existing Medical Device Directive (MDD). Since then, both the European Union and the United States have completed their 3 year transition period (May 26, 2021), by which all manufacturers should have updated their technical documentation and processes. With impacts...

The Medical Cannabis Industry and Compliance

As more states in the US consider the possibility of legalized medical cannabis use, how can we learn from other countries about the regulatory process on a federal level? Regulatory bodies around the world are instituting policy and guidelines to help ensure safe, effective cannabis production. This applies to the forty-three countries that have legalized...

21 CFR Part 11 Compliance Checklist [XLS Download]

One of the main challenges across the life science industry is maintaining 21 CFR Part 11 Compliance. These particular regulations are in place to define how companies operating within the life science space use a QMS to manage electronic records and digital signatures. Although these regulations have been in place for a while, they still...

cGMP is Extensive and Confusing

Current Good Manufacturing Practices, known as cGMP, are designed by the FDA to regulate the quality of pharmaceutical goods in the United States. With a vast array of current guidance documents to say the library is extensive is an understatement. The library includes validation, data integrity, quality metrics, and even animal and veterinary guidelines. While...

Top 5 CRMs for Healthcare and Life Science

Healthcare is an enormous and lucrative industry, one which is constantly innovating and adapting. As our capabilities, technology, and culture change and evolve, so too must our healthcare institutions. Today’s patient lives in a world populated with curated content feeds, personalized shopping suggestions, and tailored ad algorithms – and they expect a similarly customized healthcare...

ISO 13485: The Essential Audit Checklist

Downloadable to Help Prepare for Your Next Audit (XLS) The life science industry is built upon a foundation of strict regulations and standards designed to enforce product quality and patient safety. This applies to products as well as services. ISO 13485 represents an essential level of standardization and certification for Quality Management Systems (QMS) in...

Compliance in the Lab: GMP vs GLP in Laboratory Studies

The life sciences manufacturing industry is full of Good Practice standards. Every step and process is covered under some GxP; from design and testing to the manufacturing and distribution of pharmaceutical products and medical devices. When it comes to laboratory processes and validation studies, there is often confusion between Good Manufacturing Practices (GMP) and Good...