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RA covering the management, and conduct, of air system test and evaluation activity.
As the world’s leading testing, inspection and certification company, SGS prides itself on establishing the global benchmark for sustainability, quality, and integrity.
Trace-Level Testing, Validation Pressure, and the New Demands on Pharma Labs Labs are under increasing pressure to balance trace-level accuracy, validation requirement...
Changes to EU GMP rules on environmental testing and biopharmaceutical product quality are prompting manufacturers to adopt new verification processes. PIC/S support will see techn...
RA covering the requirement for instrumentation for flight tests of new types of aircraft, major modifications or special installations.
The guidance was developed to help manufacturers and laboratories in the design, conduct, evaluation, and reporting of Protein Efficiency Ratio (PER) studies.
Introduction A smoke test is the fastest, most effective way to catch critical failures before they reach production. In any software system, a smoke test answers one question: Do...
RA covering the requirement to identify the extent to which the design specifications have been achieved.
RA covering the requirement that the MOD CAM devise and execute a corrective action plan on receipt of MAA audit findings.
What ISO/IEC 17025 Asks Before, During, and After Every Test A practical guide to planning a lab that stays audit-ready throughout the whole test life cycle...
Midtier Life Sciences Companies Need to Rethink Their Regulatory Technology Strategy The hidden cost of complexity and customization Qual...
RA covering the approval, classification and application of changes in type design.
RA covering the requirement for an AMO to have a corrective action plan following an audit.
This report is intended to inform discussion and decision making, not to prescribe solutions. Produced in collaboration with GEN, it reflects the collective voice of an industry ad...
Effective July 20, to support risk surveillance, the agency will perform metals analysis on samples that are already collected for allergen verification.
New capability automates test planning, execution, and audit-ready documentation for system updates in regulated laboratories.
Testing gambling products is not standard app testing; it involves more edge cases. Testing for regulated gaming products must demonstrate that critical journeys behave correctly,...
On June 18, 2026, the Food and Drug Administration (“FDA”) announced the submission of a proposed collection of information to the Office of Management and Budget (“OMB”) pertainin...
RA requiring a comprehensive, through-life, integrity management approach to assure air system integrity.
On May 15, 2026, the U.S. Department of Agriculture (USDA) published a Request for Information (RFI) seeking public input on the future regulation of genetically engineered (GE) or...
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