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[…]
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[…]
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[…]
“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 is OOS ? An explicit set of requirements is called specification and typically it needs to be satisfied by a material, product, or service. So when a material, product or service fail to meet one or more of the applicable specifications, it is referred to as being out of specification, abbreviated as OOS. FDA Read more about Out-of-specification(OOS) , FDA Guidance – Lab Investigation Steps[…]
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 ?[…]
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 ?[…]
There are many meetings which a sponser can have with FDA related to the product being developed and to be approved by FDA. But it can be categorized in to 3 base categories. Type A: Critical Path (Urgent) meetings – Clinical hold, Safety Issues, Site disqualification, etc (within 30 days) Type B: Procedural meetings – Read more about Sponser Meeting with FDA some facts[…]
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[…]
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