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Blue Skies, LLC Life Sciences

Blue Skies, LLC Life Sciences. Contact Email: info@blueskiesllc.com |www.blueskiesllc.com Proprietary & Confidential. Blue Skies Overview. Background Founded in 2002 15 Partner Level Managers focused on: - Building long-term, caring client relationships

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Blue Skies, LLC Life Sciences

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  1. Blue Skies, LLCLife Sciences Contact Email: info@blueskiesllc.com |www.blueskiesllc.com Proprietary & Confidential

  2. Blue Skies Overview Background Founded in 2002 15 Partner Level Managers focused on: - Building long-term, caring client relationships - Being flexible and easy to work with - Possessing strong ethics and integrity - 100% Success Rate Expert Support Staff Our Mission Help Life Sciences customers maximize their business potential by delivering strategic business solutions, focused on process and data integrity, rooted in quality and compliance. Who are we • Blue Skies is a Management Consulting company specializing in IT, Business Operations and Quality. • We are focused on the Life Sciences industry. • We are experts in developing innovative strategic plans and implementing practical solutions

  3. Blue Skies, LLC | Life SciencesStrategic Expertise | Tactical ExecutionPractical Approach | Reliable Results • Why is Blue Skies different? Service Offerings • We are Life Sciences industry experts • We provide services from strategy through execution in Information Technology, Business and Quality disciplines How we can partner in your success. If you answer yes to any of these questions you could benefit from a discussion with one of our consultants: • Need a seasoned project manager to lead a critical project? • Need assistance with preparing for an FDA or ISO audit? • Need to strengthen your Quality Sub-Systems? • Looking for unbiased guidance selecting a new software system? • Challenges in your supply chain? • Need better information and metrics to manage risk for your enterprise? • In a universal market with a broad range of regulations, we help clients integrate quality and compliance into the value chain. • We assist with establishing a vision and strategy on how to sustain a compliant state while maximizing growth and profitability.

  4. Blue Skies, LLC | Quality Systems Management • Do any of the following apply to you? • You could benefit from a conversation with one of • our consultants • Need help establishing a Software Quality Program? • Got issues with your Performance Metrics ? • Have FDA-483 or Warning Letter observations to remediate? • Preparing for an FDA audit? • Need help revising Quality Systems processes and procedures? • Need help establishing a compliant Quality Manual? We are experts in Quality Systems • SDLC and Software Validation • Complaint Management • CAPA Management • Document Control Management • Non-Conforming Materials Management • Audit Management • Quality Record Management

  5. SDLC Methodology Development • Software Validation Program Establishment • Business & IT Compliance Alignment • IT Roadmap Development • Project Management Office (PMO) • IT Organizational Development and Change • Strategic Services • IT Implementation Services Blue Skies, LLC | IT Strategy & Implementation • Blue Skies reduces the complexity in Strategic Planning by working with executives to extract the vision and map out the plans. • Our teams then execute the plans to ensure quality and consistency. • Audit Preparation and Remediation • Project Management & Project Remediation • Software Implementation & Validation • ERP, PLM, WMS, QMS, CRM • Software Selection • Business & IT Process Optimization Blue Skies’ IT Strategy and Implementation services assist Life Sciences organizations in reaching its goals by working directly with executive leadership to maximize compliance, returns on investment and benefit by leveraging existing initiatives and improving future direction. All activities are based on regulatory compliance, leveraging Six Sigma DMAIC methodologies and principles. Blue Skies offers services from strategy through implementation to ensure quality and consistency throughout the engagement.

  6. Regulations for Software Validation • Title 21 Code of Federal Regulations (CFR) Part 820, and 61 Federal Register (FR) 52602, respectively stipulate that software validation is a requirement of the Quality System Regulation (QSR). • Medical products that include software are subject to applicable design control provisions- 21 CFR Part 820.30. • GAMP5 - Good Automated Manufacturing Practicecovers all aspects of production; from the raw materials, facility and equipment to the training and hygiene of staff. Standard operating procedures (SOPs) are essential for processes that can affect the quality of the finished product. We are experts in building compliant and repeatable systems and processes that meet the regulations and satisfy the auditors. Our efficient methods drive value and avoid unnecessary remediation efforts and expense. We use the DMAIC methodology and our extensive knowledge of Medical Device Regulations to drive FDA audit compliance and business success.

  7. Blue Skies, LLCLife Sciences Contact Email: info@blueskiesllc.com |www.blueskiesllc.com Proprietary & Confidential

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