IT REGULATORY COMPLIANCE SERVICES

2030 Consulting provides regulatory compliance and validation services for the Life Science industry (Pharmaceutical, Biotechnology, Medical Device and Clinical Trial). Our specialists possess the experience, knowledgebase, and tools required to help ensure our clients compliance, improve relationships with regulatory agencies, and reduce potential liabilities.

2030 offers expertise in the areas of Computer and Software Systems, Laboratory Systems, Infrastructure, and more. We provide Vendor/Partner Audits, Validation and Compliance support for some of the most notable companies in the business.

In the ever-changing regulated industries, you can count on 2030 Consulting as your partner to ensure that all necessary validation and compliance records are comprehensive, defendable, and controlled.

2030’s Value Proposition

• Systems Validation is a 2030 core practice
• We keep our team updated with changing standards and regulations
• Risk-based customized services
• Dedicated Life Sciences focus

The 2030 Advantage

We help our clients achieve and maintain compliance and validation by:

• Conducting deep analysis of our client’s current validation practices, policies, and procedures.
• Focusing on gap eliminations required to achieve compliance.
• Decreasing risk and cost of quality by providing guidance and training to create a holistic culture of compliance.
• Total Validation Packages, including: Requirements, Risk and Compliance Assessments, Validation Master Plan, IQ/OQ/PQ, Test Plans and Test Deliverables, Traceability Matrix, Standard Operating Procedures (SOP’s) and Summary Reports.
• Validation Policy, Change Control Policy, Document Deliverable Templates.

MANAGED SERVICES MODELS—Systems Validation

Extended Team Model (Ideal for POC model and clients with large FTE teams)

• 2030 Team functions as an extension to the client FTE Team
• Client holds the accountability of delivery and quality
• 100% of 2030’s deliverables are reviewed/approved by the client

Joint Accountability Model (Ideal for POC model and clients with limited FTE teams)

• 2030 Team functions as a semi-independent team
• Client and 2030 team are jointly accountable for delivery and quality
• Agreed 2030 deliverable assignments are reviewed and approved by the client

Matured Managed Services Model (Ideal for clients focused on core strengths)

• 2030 Team functions as an independent team
• 2030 is fully accountable for delivery and quality
• Good for clients that focus on core strengths