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Empowering Women in IT through Computer Systems Quality Education

Shweta Nigam recently devoted some of her time speaking at "Women in IT, Oxforshire Branch". Shweta is a Senior Quality Assurance Manager here at Zigzag Associates, and expert member of our top-tier Computer Systems Quality (CSQ) Team.


Organized by BCS IT, a global network for promoting competency and ethics in Tech, "Women in IT" is an event encouraging women to knowledge share in Information Technology (IT) industry. Shweta educated attendees about CSQ Auditing and IT Auditing as a dynamic and evolving, mission critical component of the Clinical Trials lifecycle.


Shweta talked about the evolution of CSQ to her attendees, some facts which bring a level of understanding to how dynamic CSQ is, and the pace at which we need to evolve to ensure compliance and validation.


"IT Auditing, which has grown into CSQ Auditing (Which covers both Computer Systems Compliance and Computer Systems Validation), was conceptualized relatively recently. It was first developed 1960's as Electronic Data Process Auditing. This discipline was initially described by the FDA in "General Principles of Software Validation, version 1.1, dated June 9, 1997."


"Emerging IT Audits include Technological Innovation Process Auditing, Innovative Comparison Audit, and Technological Position Audit, CSQ of Decentralized Clinical Trials"


Shweta brings our clients 16 Years Quality Assurance experience with and 10+ years of direct auditing experience. She is a vastly experienced CSV Auditor with extensive computer system validation (CSV) and data integrity auditing experience. Her depth of knowledge in adherence to applicable regulations (such as: Code of Federal Regulations 21 CFR part 11, Eudralex Regulations Annex 11, ISO 17025, UKAS FSR Codes of Practice and Conduct) and GAMP5 brings our clients complete assurance. She has experience in conducting audits (Due-diligence/ Qualification, Follow-up, internal audit) of CSV systems, (Remote, Desktop and On-site), IT Supplier/ Service Providers and any computer systems sitting within a GxP space.















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