Software Validation

CSV and Documentation

CSV and Documentation

Each regulated record (is a GMP record) and should be periodically reviewed Strong SOP and Work instructions repository covering all working areas Templates for all documentation, processes – recommended, mandatory VMP for computer systems – mandatory for all who are regulatory audited and use the same for validation across for computer systems URS – always to be prepared by the user and then can be used to prepare/compare vendor URS, FS OQ – should also include for Data [...]

Controlled Cost effective CSV

Controlled, Cost-effective CSV

CSV is mandatory for implementation of software systems in a GxP regulated environment. And, it would incur huge costs if not handled adequately. With increasing number of software systems implemented in any organization, it becomes utmost important to check the costs at every step, especially of CSV. The CSV tools include the following: Mandate! To protect public health, safety To ensure consumers access to safe, effective, affordable medicines How? Regulations Guidance documents Regular inspections Enforcing actions Today… GMP violations & non-compliance Data integrity issues [...]

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 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, [...]


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…)