Rescop

Office Address

Roosakkerstraat 13 5111 CL
Baarle-Nassau The Netherlands

Phone Number

+31 (0)85 201 72 77

Email Address

info@rescop.com

complaints@rescop.com

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Data Integrity

In the fast-paced world of life sciences, ensuring data integrity is crucial for compliance, operational efficiency, and the reliability of critical business information. At Rescop, we are dedicated to helping pharmaceutical, biotech, and medical device companies manage their data integrity effectively. Our risk-based approach not only identifies areas of vulnerability but also enables a tailored remediation plan to safeguard your data throughout its lifecycle.

Our Data Integrity Services

  1. Data Integrity Assessment & Gap Analysis
    Our team conducts thorough assessments of your current data processes, identifying gaps and weaknesses in data integrity. We evaluate systems, policies, and practices against industry standards like 21 CFR Part 11, Eudralex Annex 11, and GAMP guidelines to ensure compliance and data security.

  2. Remediation Planning & Risk Management
    After identifying gaps, we prioritize remediation efforts based on potential risks and impact. This allows us to provide strategic, risk-based remediation plans to ensure timely and effective resolutions. Our approach not only strengthens compliance but also promotes operational efficiency.

  3. IT System Qualification & Validation
    We deliver a comprehensive qualification and validation of your computerized systems, ensuring they are secure, reliable, and compliant. Our specialists use a risk-based approach aligned with GAMP 5 standards to validate that your IT systems meet regulatory requirements, securing the integrity of your data.

  4. Data Integrity Toolbox & Solutions
    Rescop's data integrity toolbox provides a suite of solutions designed to secure and maintain data throughout its lifecycle. This toolbox is built upon best practices and industry standards, offering a reliable and efficient approach for ensuring your data integrity is consistently upheld.

  5. Onsite Project Teams & FDA/EU Inspection Readiness
    We provide project teams experienced in data integrity and regulatory inspections, ready to support your organization in ensuring compliance readiness. Whether it’s FDA or EU inspections, our specialists work onsite to implement practices that ensure your data meets the highest quality standards.

Why Choose Rescop's Data Integrity Services?

  • Industry-Compliant Solutions: Our methodologies adhere to leading industry standards like 21 CFR Part 11, Eudralex Annex 11, and GAMP guidelines, ensuring your data integrity meets all regulatory requirements.
  • Risk-Based Remediation & Management: With our risk-based approach, we identify, prioritize, and mitigate risks effectively, securing your data and processes for long-term integrity.
  • Proven Expertise & Practical Experience: Our team is composed of experts with years of hands-on experience in data integrity programs, providing practical, efficient solutions tailored to your needs.
  • Operational Efficiency & Cost-Effective Solutions: By optimizing your data management practices, we help reduce costs associated with compliance issues and enhance overall operational efficiency.
  • Inspection Preparedness: Be ready for any regulatory audit or inspection with our experienced onsite teams and solutions designed for FDA and EU compliance readiness.

 

 

 

Roles of Rescop in Data Integrity Projects

  • Project Management: Managing all aspects of the project lifecycle to ensure timely, effective, and compliant data integrity practices.
  • Data Integrity Assessment: Performing comprehensive evaluations to identify and address gaps in data management and quality.
  • Remediation: Prioritizing and implementing necessary changes to improve data security and compliance, based on risk assessments.
  • Change Control: Managing and documenting changes to systems and processes, ensuring they align with data integrity standards and practices.
  • Qualification & Validation of IT Systems: Ensuring your IT systems are compliant, validated, and qualified to maintain the highest data integrity standards.

With Rescop as your partner, you can confidently navigate the complexities of data integrity, knowing your business information is secure, reliable, and compliant with the latest industry regulations.

 



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