Scilife Blog

We all know the EU GMP Annex 1 guideline: Manufacture of Sterile Medicinal Products. Yet manufacturing is evolving, and new technologies have emerged in recent years. It’s important that companies in the Life Sciences stay on top of these changes.

If we were to compare ISO 9001 vs ISO 13485, which one should you adhere to?

Any medical device manufacturer developing new products comes across design verification and validation. They are essential stages during the design control of a new medical device. Design controls are a series of steps and processes during the devel...

While the pharmaceutical industry continues to grow and evolve, GMP (Good Manufacturing Practice) compliance remains a top priority to ensure the safety and quality of products. Therefore, GMP is essential to every pharma manufacturing process to mai...

As of February 2, 2026, the transition period for the Quality Management System Regulation (QMSR) has officially ended. The FDA now expects full compliance with this new framework, guaranteeing that FDA 21 CFR part 820 and ISO 13485 operate as one.

Top 11 FAQs about GMP Guidelines for Quality Management Systems The GMP guidelines are mandatory in most countries for pharmaceuticals, medical devices, and food industries. Companies that fail to comply with these guidelines can face severe regulato...

In GxP-regulated sectors like pharma, biotech, and medtech, computerized systems play a key role in ensuring patient safety, data traceability, regulatory compliance, and integrity. Many regulations and guidelines have been developed to validate such...

What Are ATMPs? ATMPs is an acronym for Advanced Therapy Medicinal Products. These medicinal products are based on genes, tissues, or cells. Research shows that ATMPs provide promising therapeutic applications for Alzheimer's disease, cancer, muscula...

As the life sciences are digitalizing at an unprecedented scale and rate, data lifecycle management is becoming more important than ever.

Internal audits can strengthen the quality management system (QMS) of your organization by improving sub-processes by identifying open issues and opportunities. In addition, internal audits can be more informal than external audits, so that your orga...

Staying ahead of industry shifts has never been more critical for anyone working in biotech, pharma, or MedTech. The pace of innovation is accelerating, regulatory expectations are tightening, and AI is reshaping everything from discovery to commerci...

We all know at least one John, who was a great fit for the job posting published by the organization last week, but the talent manager never knew about John. The talent manager failed to recognize the talent within the organization and hired a new em...