Business and GxP compliant solutions, services by SarjenBusiness and GxP compliant solutions, services by SarjenBusiness and GxP compliant solutions, services by Sarjen

Shilpa Desai

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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…
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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…
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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…
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What is SSIS? Its advantages and disadvantages

SSIS stands for “SQL Server Integration Services”, Microsoft have their many products to compete different segment. To compete in segment of data migration, ETL and transformation, Microsoft had introduced their tool with SQL 2005. Microsoft empowers it with all the ammunition to help data migration, transformation, ETL and other function.…
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QA and client handling

Client calls are integral part of software development and deployment. It directs and coordinates the flow of the directions for development and deployment; keeping the channels of communication open throughout various teams within the company. For a QA, client call can spell disaster many a time; especially when those calls…
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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.
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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 24×7, convenient, on-demand network access to a shared pool of configurable computing…
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