Computer System Validation (CSV) Expert (Pharma Domain)

By Rcsolutions I.

Computer System Validation (CSV) Expert (Pharma Domain)
India

About This Service

Are you a pharmaceutical company seeking to streamline your quality management system (QMS) and ensure compliance with US FDA guidelines? Look no further! With over 15 years of experience in the pharmaceutical industry, I am a seasoned consultant in Regulatory Compliance and Computer System Validation (CSV) . My expertise lies in the realm of technical documentation and compliance validation, encompassing various regulatory authority guidelines.

I am committed to providing comprehensive assistance to companies navigating the complexities of compliance with 21 CFR Part 11 Electronic Records and Electronic Signatures, as well as Annex 11, Computerized Systems. My focus extends to offering holistic solutions for quality management systems, encompassing various investigative processes within the pharmaceutical domain. I am also dedicated to crafting comprehensive and compliant QMS documentation that meets the highest standards of data integrity and regulatory adherence.

I deliver academic excellence, hands-on experience, and unwavering data integrity to every project. My expertise seamlessly integrates Data Analysis and Change Management (Lean Six Sigma, DMAIC) to tackle Investigations, CAPA, Qualifications, Calibrations, and Chromatography (HPLC, GC-MS). Proficient in MS Office and Google Workspace.

Contact me today to discuss your Regulatory Compliance, Computer System Validation (CSV) and QMS document development requirements and embark on a journey towards pharmaceutical excellence.

What seller need from the Buyer to get started?

We can discuss as per the requirement.

Phase 1: Gather Information and Requirements:

Review existing documentation, procedures, and records.
Identify gaps and areas for improvement in the organization's .

Esitmated cost is $995.23 & delivery in 7 days

About The Seller

Rcsolutions I. - Computer System Validation (CSV) Expert (Pharma Domain), from India

I am a seasoned consultant in Regulatory Compliance and Computer System Validation (CSV) holding an MSc degree. My expertise lies in the realm of technical documentation and compliance validation, encompassing various regulatory authority guidelines. I am committed to providing comprehensive assistance to companies navigating the complexities of compliance with 21 CFR Part 11 Electronic Records an...

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