Life science companies deal with tons of data; this data could be related to processes (manufacturing, process controls, equipment, administrative, financial, legal, medical), product (physical attributes, study reports, analytical documents, batch records),...
News & Blog
What is an Electronic Quality Management Software (QMS) Solution?
With the advent of global competition, maintaining quality standards has become increasingly important for companies in these industries. As a result, many biotechnology and pharmaceutical companies are turning to electronic quality management software (eQMS)...
Guidance on Common Regulations and Standards
Whether a company is in the life science industry, or providing products in the pharmaceutical, biological, medical devices, cosmetics, veterinary products, there are many regulations and standards developed by regulatory agencies such as US Federal Food and Drug...
Manufacturing Equipment and Laboratory Equipment Validations
With the advent of global competition, maintaining quality standards has become increasingly important for companies in these industries. As a result, many biotechnology and pharmaceutical companies are turning to electronic quality management software (eQMS)...
Outsourcing Supplier Qualification and Auditing
If you work in the life science industry, you know how important it is to maintain the highest standards throughout your product's life cycle - from ideation to the end user. A crucial component of this life cycle is the "supplier." The supplier provides the raw...
Difference Between CTD and eCTD Submission Formats
What is an eCTD submission? The Electronic Common Technical Document (eCTD) allows for the electronic submission of the Common Technical Document (CTD) from applicant to regulator, such as the USFDA or EMA. The Common Technical Document describes the organization of...
Structure of the Common Technical Document (CTD)- M4 Guideline
What is the Common Technical Document (CTD)? The Common Technical Document (CTD) format or dossier was designed by the ICH and was agreed upon as a common format between three major regulatory regions, i.e. European Union (EU), USA, and Japan for submission of...
Top 2 FDA Citations to Avoid
The consequences of FDA citations can be costly. In this blog article, we discuss the top two FDA citations for pharmaceuticals and how to avoid or prevent them. In the United States of America, pharmaceutical drugs and medical devices are controlled according to The...
Quality Risk Management for Commissioning and Qualification
Engineering is the backbone of successful design, installation, and maintenance of manufacturing. Commissioning, Qualification, and Validation (CQV) in pharmaceutical and medical device industries define a detailed and science-based process for the specification,...
Inspections and Audits: What You Need to Know
Are you worried about an inspection from the FDA, MHRA, or another global regulatory agency? Use the anxiety and learn about inspection and audit best practices in our series of blogs on inspection management. The Importance of First Impressions on Inspection Day Did...