Supplier Management Key elements & Guidance

Posted on December 20, 2020December 20, 2020 by admin

A Supplier Management Program should have below elements : Definition of the product’s quality requirements Evaluation of alternative suppliers Selection of the most appropriate suppliers Conduct joint quality planning Co-operation during relationship period Validation of conformance to requirements Certification of qualified suppliers Conduct quality improvement plans Creation and use of supplier rating Guidance for Supplier Read more about Supplier Management Key elements & Guidance[…]

V & V Documentation Model – 11 Documents

Posted on December 19, 2020December 19, 2020 by admin

There are 11 document types in the basic V&V Documentation model as per “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”, Table 3, May 11, 2005: LOC (Level of Concern: Min, Mod, Maj) SW Description Hazard / Risk Analysis (ISO 14971 / ICH Q9 = recommended model; ultimately Read more about V & V Documentation Model – 11 Documents[…]

Common issues related to data integrity

Posted on November 30, 2020January 31, 2021 by admin

Data integrity is “The maintenance of, and the assurance of the accuracy and consistency of, data over its entire life cycle, and is a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves data. Data integrity is the opposite of data corruption, which is a form of data Read more about Common issues related to data integrity[…]

FDA’s Dec 2018 Guidance on Data Integrity

Posted on November 30, 2020January 31, 2021 by admin

What is Data Integrity ? The definition of Data integrity is that a data need to be complete, consistent, and accurate . The concept applies to CGMP and Good Clinical Practice (ICH E6). Data should be “ALCOA” ( Attributable, Legible , Contemporaneous, Original or true copy, Accurate ) Key Concepts of Data Integrity: Metadata : Read more about FDA’s Dec 2018 Guidance on Data Integrity[…]

What is GxP Systems ?

Posted on November 30, 2020November 30, 2020 by admin

“GxP” is defined as “Good-X-Practice,” based on FDA “Predicate Rules”. The X can be filled by “M” to make GMP = Good Manufacturing Practice, by “L” to make GLP = Good Laboratory Practice, by “C” to make GCP = Good Clinical Practice. GMP: The systems used in quality control laboratories supporting manufacturing operations GLP: The Read more about What is GxP Systems ?[…]

What are Layered Process Audits ?

Posted on November 18, 2020November 18, 2020 by admin

Layered Process Audits (LPAs) are merely: DAILY CHECKS OF HIGH-RISK PROCESSES and documented with reference to FDA Internal Audit. This is where you actually have various people come and do mini-inspections, mini-audit periodically or may be daily and document that. Here are few of the principles listed out which will help you. Implementation: Consists of Read more about What are Layered Process Audits ?[…]

What is Pregnant pause in FDA Inspection ?

Posted on November 18, 2020November 18, 2020 by admin

Pregnant pause is a technique used during FDA inspection so that the answering staff do not answer questions more that required and get in to trouble. Inspectors are very good at asking questions to know details and catch if something is not right during the conversation. It is said that when you are lying you Read more about What is Pregnant pause in FDA Inspection ?[…]

New & changed Elements in ISO 14971:2019 Release – 3rd edition

Posted on August 16, 2020August 16, 2020 by admin

ISO 14971 third edition is released in December 2019 which cancels and replaces ISO 14971 second edition. Overall, there is not much change has occurred as the risk management process itself remains largely unchanged. However , there are important clarifications and updates in ISO 14971:2019 which are as below. Similarly ISO TR 24971 second edition Read more about New & changed Elements in ISO 14971:2019 Release – 3rd edition[…]

IEC 62304 Placement in Medical Device Regulations & Standards Chart

Posted on August 16, 2020August 16, 2020 by admin

Prerequisites: ISO 62304:Quality Management System (QMS) – ISO 13485 Risk management – ISO 14971 IEC 62304: Software safety classification Software development process Software management process Software configuration management process. Software problem resolution process Medical Device Standards in One Frame

Medical Device Supply Chain – Managing the long chain as per FDA regulations

Posted on August 6, 2020August 15, 2020 by admin

It is a common strategy for Medical device Manufacturers to outsource the manufacturing and services function to low cost destinations. But with the benefit of low cost also comes lots of problems related to regulations and management. As the supply chain becomes longer and more diverse and now with COVID-19 situation many disruptions getting surfaced, Read more about Medical Device Supply Chain – Managing the long chain as per FDA regulations[…]