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GxP Systems Implementation

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Lean and Accelerated GxP Systems Implementation Service  for Faster Go-Live with Regulatory Compliance

Pharma companies and Contract Research Organizations (CROs) have a major responsibility to ensure that all business process systems used within the enterprise are implemented, validated and used in a regulatory compliant manner.

Today, as organizations transition to cloud-based technology options, key stakeholders encounter challenges related to compliance, completing multi-regional / multi-site rollouts, defining controls for information security and planning for long-term scalability.

How Have We Helped Our Clients for over 10 Years

BUSINESS AND SYSTEM REQUIREMENTS ELICITATION

Our Pharma domain experts have worked extensively on a wide-range of enterprise applications used for managing GxP business processes and associated data. This includes software systems used for collecting and managing clinical trial data from pre-clinical to post-marketing of medicinal products.

One of the critical success factors for any successful software system implementation is business scope definition, requirements management and traceability.

Our Approach

Provide Requirements Elicitation Questionnaires and Documentation Templates
Complete Stakeholder Interviews, Use Case Modelling, Prototyping
Group and Prioritize Requirements (URS, FRS, Design, Regulatory, Data Privacy)
Evaluate Requirement Relationships and Functional Impact with 100% Traceability

STRATEGIC TECHNOLOGY ROADMAP DEFINITION

With advances in technology, Pharma and Life Science Organizations find it extremely difficult to evaluate, implement and realize the value of their IT investments with changing priorities and budget constraints.

Our Capability

  • Expert Knowledge on Pharma Industry Value Chain
  • 10+ Years of Practical Technology Consulting Expertise
  • Highly experienced SMEs and Domain Consultants
  • Personalized Solutions that are Quality and Value-oriented

How We Help Clients to Make the Right Choice

Offer Advisory Services for Technology Selection and Business Fit-Gap Analysis
Layout the Path for Long-term Scalability and Benefits Realization
Execute IT Risk Management and Provide a Compliance Governance Framework
Identify Opportunities for Value Generation and Knowledge Management

Learn More About our Accelerated Cloud Solutions

As a trusted cloud technology partner, we have enabled several small and mid-size organizations to leverage our fully-managed Drug Safety, Pharmacovogilance and Medical Affairs Cloud Solutions for their business processes.

GLOBAL SYSTEMS IMPLEMENTATION AND VALIDATION

The successful implementation of a GxP system requires a comprehensive understanding of the system requirements, global regulations, validation knowledge and the expertise to facilitate stakeholder collaboration in alignment to the organization’s business goals.

Our Capability

  • Delivered over 100+ GxP systems implementation projects
  • Hands-on Experience in Risk-based Systems Validation
  • Highly experienced validation subject matter experts
  • Proficiency in Compliance and Data Privacy Regulations
  • Project delivery within the allocated timeline and budget

How We Add Value to Clients

Provide Inputs to Cross-Functional Teams for Business Process Design
Offer Ready-to-Use Validation Kits prepared using GAMP-5 Principles
Provide Accountability for 21 CFR Part 11, EU Annex 11, GDPR, HIPAA compliance
Deliver audit-ready validation deliverables for the target GxP system
Provide hands-on application training to End-users and System Administrators
Orchestrate phased Global Solution Rollout with a centralized Deployment Plan

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