VaLogic Bio News and Updates
Contact Us The Regulatory Roadmap: FDA, EMA, and MHRA Alignment Strategies Your site just received notice of an upcoming FDA inspection. Great—you’ve been preparing for months. But you also supply to EU and UK markets. Your EMA inspection is next quarter, and MHRA might show up anytime after that. Now you’re managing three inspection preparation … Read more
Contact Us The Anatomy of an Effective Validation Protocol: 8 Essential Elements Validation protocols are the backbone of pharmaceutical compliance. They define what you will test, how you will test it, and what a passing result looks like. But many protocols fall short not because the science is wrong, but because the document itself is … Read more
Contact Us Mapping Your QMS: Where Does Your Documentation Actually Live? If I asked you right now, “Where is your validation master plan?” could you answer in under 10 seconds? What about your critical process SOPs? Your completed batch records from two years ago? If you hesitated, you’re not alone. One of the most common … Read more
Contact Us Key Tests in the Cleanroom Certification Process Cleanroom certification is a critical foundation for ensuring safe, consistent, and compliant operations across life sciences, pharmaceuticals, and advanced manufacturing. Whether you’re managing sterile drug production, assembling sensitive microelectronics, or manufacturing cell and gene therapies, cleanroom testing provides objective verification that your environment supports rigorous quality … Read more
Contact Us The Scope of Environmental Monitoring for Cleanroom Compliance Environmental monitoring (EM) systems are a critical tool for maintaining control over cleanroom compliance, allowing you to catch potential issues before they affect your bottom line. This article explores the full scope of cleanroom environmental monitoring services—from airborne particles and viable surface swabs to compressed … Read more
Contact Us The ISO 14644 Series Explained ISO Cleanroom Certification at a Glance ISO cleanroom certification is the benchmark that proves your environment is built and controlled to global expectations. For biotech, pharma, device, and aerospace teams, the standard framework is the ISO 14644 series. At its core: ISO 14644-1 defines air cleanliness classes. ISO … Read more
Contact Us Cleanroom Certification Explained: Standards, Testing, and Compliance If you run a regulated lab, pharmacy, or production suite, cleanroom certification proves your controlled spaces actually perform to spec. This guide breaks down what certification covers, which standards apply, how testing works, and how to keep performance steady between certifications, so your team can focus … Read more
Contact Us VaLogic Achieves ISO 17025:2017 Certification from the American Association for Laboratory Accreditation (A2LA) Frederick, MD – August 14, 2025 – VaLogic, a regional leader in laboratory calibration and biological testing services, proudly announces that it has achieved ISO 17025:2017 certification through the American Association for Laboratory Accreditation (A2LA) in both calibration and biological fields. … Read more
Contact Us VaLogic Bio Enhances Client Support with Acquisition of Air Systems Technologies Frederick, Maryland – July 30, 2025 – VaLogic Bio has acquired Air Systems Technologies (AST), expanding the services available to life sciences organizations across the Mid-Atlantic and New England regions. AST brings more than 40 years of experience supporting over 1,100 biotech, … Read more
Contact Us VaLogic Bio Achieves ISO 9001:2015 Certification, Demonstrating Commitment to Excellence in Biotech and Life Sciences Service Frederick, MD – January 7, 2025 – VaLogic Bio LLC, a trusted partner in providing Calibration, Certification, Validation, Testing Equipment, Laboratory Services, Software Development, and Consultancy for the biotechnology and life sciences industry, is proud to announce … Read more