Skip to content
PharmExpert Consultant LLP
Validated systems, trustworthy data, smarter digital operations.

Computer Systems Validation & Digitalization

As pharmaceutical operations digitize, the systems that run them must be validated, the data they hold must be trustworthy, and the digital tools you adopt must deliver value without creating compliance debt. PharmExpert delivers risk-based CSV/CSA, Part 11 / Annex 11 compliance, data-integrity solutions, and a full suite of digitalization services built on GAMP 5 principles.

From workflow automation, eDMS and digital quality platforms to eCTD software, cloud-compliance assessment and vendor qualification, we help you validate efficiently, govern data to ALCOA+, and build a pragmatic digital-transformation roadmap.

01

Computer System Validation (CSV) / Computer Software Assurance (CSA)

Risk-based CSV and modern CSA across the system lifecycle using GAMP 5, scaled to system risk and complexity.

Explore
02

21 CFR Part 11 / Annex 11 Compliance

Assessment and remediation for 21 CFR Part 11 and EU GMP Annex 11 — electronic records and signatures done right.

Explore
03

Data Integrity Solutions

Technical and procedural data-integrity solutions — governance, audit-trail review, access control and ALCOA+ controls.

Explore
04

Workflow Automation Solutions

Design and validation of automated GxP workflows that cut manual effort while preserving compliance and data integrity.

Explore
05

Electronic Document Management Systems

eDMS selection, implementation and validation for controlled documents, with compliant version control and audit trails.

Explore
06

Digital Quality Management Platforms

eQMS selection, implementation and validation that digitize deviation, CAPA, change control, audits and training.

Explore
07

Regulatory Software (eCTD)

Selection, implementation and validation of eCTD publishing and regulatory information management software.

Explore
08

Digital Transformation Roadmaps

Digital-maturity assessment and a phased, compliance-first roadmap to modernize quality and operations.

Explore
09

Cloud Compliance Assessments

Assessment of cloud and SaaS solutions for GxP compliance, data integrity, security and supplier assurance.

Explore
10

Vendor System Qualification

Supplier assessment and qualification of system vendors to support risk-based, leveraged CSV.

Explore
Standards & Frameworks
  • GAMP 5 (2nd ed.)
  • FDA Computer Software Assurance (CSA)
  • EU GMP Annex 11
  • 21 CFR Part 11
  • GAMP 5
  • MHRA/FDA data-integrity guidance
  • ALCOA+
  • MHRA / FDA / WHO data-integrity guidance
  • PIC/S PI 041
  • ICH Q10
  • EU GMP Chapter 4
  • ICH M8 (eCTD)

Talk to a computer systems validation & digitalization specialist

Tell us about your challenge and we'll propose a scoped, independent engagement — with a transparent quote.

Request an Audit +91 70468 82130