Computer System Validation (CSV)

Significance of CSV in Life Science Industries & How is CSV approach related to SDLC?

Computer System Validation (CSV) is the practice of ensuring that any software or hardware which meets its purpose with regulatory guidelines. The pharmaceutical business model is emerging, and CSV is becoming even more crucial because of the increasing scope of information systems, more integrated functionality, consolidation, and archiving requirements. It helps companies to maintain its quality standards. US FDA defines CSV as establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting [...]

Data-integrity-and-software-validation

Data integrity and Computer Software Validation (CSV)

For any software implemented, regulatories in their audit look for adherence to regulatory and quality standards. These standards would include the following: GxP US FDA’s 21 CFR Part 11/EU Annex 11 (Electronic records and signatures) US FDA GMP (211.68) Automatic, mechanical, or electronic equipment or other types of equipment, including computers, or related systems that will perform a function satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product If such equipment is so used, [...]

definitions

Some QA definitions

Qualification – applies to hardware, devices; not the process in which the hardware is used. Thus, verifies the hardware is suitable to do a task. Verification - applies to the evaluation at intermediate steps when the software is developed to check for the correct approach to the final product. (more…)

Cloud hosting and validation

Cloud hosting and validation

In the last few years, cloud hosting has emerged as a preferred choice which has enabled companies to get out of maintaining their own servers to host various software applications where cloud computing is a model for enabling 24x7, convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, servers, storage, applications and services). (more…)

latest-trends in software validation

Latest trends in software validation

There is a need to follow strict documentation with Document Control, SOPs, etc. with their audit histories for them to comply with GxP. As it is a regulatory requirement, we, as software vendor, we have tried to incorporate SOPs and have reviewed and modified them as time has gone by to comply with them. (more…)