Our Services

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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Advance your compliance with our Six-Point Offering, monitored through a huddle, community of practice (COP) or DI Governance Board:

1. Customizable Template Suite:
Swiftly establish PQS Data Integrity procedures, including policy, SOPs, risk assessment, DI protocol, and defense strategy.

2. Audit & Inspection Reports:
Comprehensive assessment and remediation plans, change record strategy, execution schedule, metrics, and management reporting.

3. Data Integrity Solutions for Maual Processes:
Assess, enhance, and implement data integrity in paper-based processes, ensuring robust compliance.

4. System Integration & Compliance:
Integrate regulatory requirements into PQS and system lifecycle management, aligning qualification and validation with the CSA approach.

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5. Vendor Data Integrity: 

Utilize our questionnaire for thorough vendor DI assessments.

6. Taining & Maturity Assessments:
Regular updates on evolving regulations, optimization of your data integrity framework for sustained success, and development of training content.

Culture of Continuous Improvement: We believe in
fostering a culture of continuous improvement by embedding best practices within your organization, ensuring ongoing data integrity maturiy, learning and compliance.

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WHY? This end-to-end approach ensures efficient and effective compliance without over- or under-investing in solutions. Remember, Data Integrity is a continuous journey, not a one-time project.

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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.