International Organization for Standardization (ISO) 17025 accreditation is the gold standard for testing and calibration laboratories worldwide. It signifies adherence to rigorous quality management practices and demonstrates competence in generating accurate and...
News & Blog
How Can Outsourcing Professional Services Boost Your Company?
In the dynamic landscape of modern business, companies constantly seek innovative strategies to streamline operations, enhance productivity, and drive growth. One such strategy that has gained significant traction in recent years is outsourcing professional services....
CQV: Where to Start? A Comprehensive Guide to Commissioning, Qualification, and Validation
As the life science industries continue to evolve, the emphasis on regulation, safety, and efficiency is more pronounced than ever. Verifying a company has and follows standard operational procedures (SOPs) addressing each category using the tried-and-true methods of...
PSC Biotech CSV Services
This interactive carousel offers a concise and engaging exploration of PSC Biotech's CSV (Computer System Validation) services. CSV is a critical component mandated by the FDA to ensure the accuracy, reliability, and consistency of computer systems used in the life...
21 CFR Part 11
The timeline of the 21 CFR Part 11 (Code of Federal Regulations) marks a significant evolution in regulatory standards within the United States. The Significance Today The 21 CFR reflects an ongoing commitment to ensuring the safety, quality, and efficacy of products...
Embracing the Era of Digital Transformation
In today's rapidly evolving technological landscape, digital transformation has become imperative for businesses across industries. It's a fundamental shift in how organizations operate, engage with customers, and deliver value in the digital age. Embracing digital...
ICH Q8 – Quality by Design
The ICH Q8 guideline focuses on pharmaceutical development. It aims to establish a systematic approach to designing, developing, and manufacturing pharmaceutical products. This guideline is intended to provide guidance on the contents of Section 3.2.P.2...
From Simple to Spectacular: A Beginner’s Guide to Technical Drawings
Drawings are a graphical way of representing an idea, a concept, or an entity in a two-dimensional plane. It is one of the oldest forms of communication, dating further back than verbal communication. It communicates all necessary information about an abstract graphic...
The Complete CQV: Where to Start
Commissioning, Qualification, and Validation (CQV) in the life science pharmaceutical and medical device industries define a detailed and science-based process for the specification, design, and verification of new equipment or systems into a production pipeline. In...
As-Built Data: A Vital Component of Construction Project Handover
Maintaining as-built information is critical throughout the lifecycle of a facility project. As-built information contains pertinent data to support maintaining operations and project decision-making. Since it provides a method of comparing the intended and actual,...