Regulatory bodies such as theU.S. Food and Drug Administration (FDA), European Commission, andInternational Organization for Standardization (ISO)set forth specific requirements for a quality management system to ensure companies are complying with standards such asTitle 21 CFR 820,Title 21 CFR Part...
They’re both requirements of ISO quality standards and regulations like the FDA’s 21 CFR PART 820. But how do you make your response to these demands as Lean and efficient as possible? What is Quality Control (QC)? Quality Control (QC) are the tests carried out to ensure products work...
Modern quality management is a complex discipline, covering a range of activities. And in regulated sectors like life science, processes like quality assurance (QA) and quality control (QC) arebothrequired by standards likeFDA 21 CFR 820orISO 9001. What is quality assurance? How does it differ...
a critical element of this statement is a manufacturer’s ability to prove that you follow documented processes consistently. These requirements align with the FDA regulations set forth in 21 CFR part 820, but still
Titanium Tubing ASTM B338 Grade 2 Product Introduction NAME Titanium Tubing ASTM B338 Grade 2 GRADE GR1, GR2 STANDARD ASTM B337, ASTM B338, ASTM B861, ASTM B862 DIMENSION (MM) OD10-168*WT0.5~10.0×L2000-15000mm (Cold Roll &Seamless tube) OD10-820*0.5-25*1000-30...
The main goal of an MES is to ensure effective execution of the manufacturing operations and improve production output.
Titanium Tubing ASTM B338 Grade 2 Product Introduction NAME Titanium Tubing ASTM B338 Grade 2 GRADE GR1, GR2 STANDARD ASTM B337, ASTM B338, ASTM B861, ASTM B862 DIMENSION (MM) OD10-168*WT0.5~10.0×L2000-15000mm (Cold Roll &Seamless tube) OD10-820*0.5-25*1000-3...
Of course, there are other regulations that require life science companies to have a QMS in place including FDA 21 CFR Part 820 for medical devices and21 CFR Part 211for drug products. Note that21 CFR Part 820 is currently in revision to more closely align with ISO 13485. ...
The list of applications for vertical focus probing is quite long and covers all areas of manufacturing and production, from the tool industry and precision manufacturing to the automotive and aerospace industries. Now even holes, bores, reference surfaces, contours or lengths can be measured opticall...
In thedocument, it mentions that Subpart G – Production and Process Controls (P&PC) in 21 CFR Part 820regulation is with the number one ranking in FDA 483 Observations in year 2014, and Section 820.75(a)(the most representative clause of process validation) is cited with the top…Yeong-...