Approach

At Aarya Consultants, our compliance strategy is built on the latest regulatory guidelines and industry best practices. Our integrated approach to  Commissioning & Qualification (C&Q) and Computer System Validation (CSV) enhances project quality, timeline, efficiency, and cost-effectiveness. We align with key standards, including:

• ISPE GAMP 5 – For Computer System Validation (CSV)

• USFDA 21 CFR Part 11 – For electronic records and signatures

• ISPE Baseline Guidelines – For Commissioning & Qualification (C&Q)

• EudraLex Volume 4 – For sterile manufacturing compliance

• EU GMP Annexure 11 – For Computer System Validation (CSV)

• General Data Protection Regulation(GDPR): For Patient Data

• Health Insurance Portability and Accountability Act(HIPPA): For Patient Data