BioTechData
Our Services
Unlock the secrets to Data Governance and Data Integrity success with our complimentary guide, "Data Governance in Pharma: A Pragmatic Approach to Data Integrity" Gain valuable insights, best practices, and strategies to achieve and maintain compliance.
Data Integrity Kickstart
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Accelerate your journey towards compliance with our Three-Point Offering:​
1. Digital Landscape Assessment: Quickly assess your current systems using our comprehensive questionnaire.
Benefits: Understand key objectives, systems landscape, known gaps, and digital maturity.
2. Gap & Strength Analysis: Develop a tailored plan to address these areas, ensuring a robust Data Integrity framework.
Benefits: Identify strengths and gaps in your systems and processes.
3. Execution & Simplification:
Apply first principal thinking to develop solutions that precisely align with your business needs, enhancing both efficiency and compliance.
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Benefits: Align with the stage of your business (clinical vs commercial), ensuring no overdoing or underdoing.
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WHY? This service allows us to gain a thorough understanding of your key objectives, systems landscape, known gaps, and the maturity of your digital systems. With these detailed insights, we will develop a tailored plan to establish a robust Data Integrity framework. This ensures that your organization meets regulatory requirements while enhancing operational efficiency. Our pragmatic approach creates specific solutions that align with your business needs.
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End-to-End Compliance Solutions
Advance your compliance with our Five-Point Offering, monitored through a Data Governance Board:
1. Data Goverance Framework & Strategy:
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Enterprise framework development
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Policy and SOP suite establishment
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Maturity assessment and roadmap development
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Industry benchmarking against leading practices
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Digital maturity evaluation and gap analysis
2. QMS Integration:
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Comprehensive PQS assessment
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Data lifecycle management
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System integration strategy
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CSV/CSA approach implementation
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Audit and inspection readiness
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Risk-based compliance monitoring
3. QMS Audit & Inspection Reports:
Comprehensive assessment and remediation plans, change record strategy, execution schedule, metrics, and management reporting.
3. Process Excellence & DI:
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Paper and electronic process assessment
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Risk-based controls implementation
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Data integrity by design
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Process optimization
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Performance metrics establishment
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Manual process enhancement
4. System Integration & Compliance:
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Integrate regulatory requirements into PQS, data life-cycle management, and system lifecycle management aligning qualification and validation with the CSV/CSQA approaches. ​​
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Utilize our questionnaire for thorough vendor DI assessments.
5. Sustainability:
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Multi-tier training program
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Change management strategy
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Continuous improvement framework
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Performance monitoring
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Regular maturity reassessment
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Best practice sharing through CoP
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WHY?
This integrated solution ensures efficient compliance while driving business value through:
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Benchmarked performance against industry leaders
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Risk-based investment prioritization
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Data culture and ownership
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Sustainable compliance framework
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Measurable business outcomes
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Digital Accelerator Services
Partner with us to craft a tailored digital strategy that aligns with your core business objectives. By prioritizing Digitalization, Data Connectivity, and Data Integrity, we create a comprehensive roadmap for seamless digital system integration, ensuring efficiency and value without unnecessary costs.
We also provide ad-hoc management by sitting in for a leader on leave.
Key Focus Areas:
1. Support Systems, Upgrades, Replacements, and Maintenance:
Manage DCS, MES, QMS, DMS, and LMS systems in collaboration with SMEs.
2. Process Mapping:
Utilize Lean principles to simplify complex processes and to reduce cycle time.
3. Process Automation Robotics:
Identify RPA candidates to enhance speed and reduce waste.
4. IT Solutions:
Translate pain points into practical approaches for quickly selecting new or adopting existing IT tools.
5. AI Adoption:
Identify opportunities for AI implementation to optimize processes.
6. Digital Quality:
Provide Quality, risk management, system integration, and compliance support to ensure all digital systems and processes comply with relevant regulations and industry standards.
7. Training Content Development:
Develop training content to ensure smooth adoption and implementation of new digital systems and processes.
8. Project and Process Management:
Oversee project and process management to drive efficiency and success.
Get a Quote
Contact us today to get a customized quote tailored to your unique needs.