Shilpa Desai

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…

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…

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…

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…

Very “synonymous words”, DS and DQ, and can many a time be misleading, We might want to say one but speak the other and then would need clarifying. One of the set of such words include – Design Specification (DS) and Design Qualification (DQ).

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.

A query… It is a common belief across that the softwares developed by known and established software vendors (with a brand value) are more accepted, preferred by the companies. And, also they face less queries and questions; are more accepted from the regulatory agency auditors than the other establishing software…

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 24×7, convenient, on-demand network access to a shared pool of configurable computing…