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

GxP Laboratories

We understand the importance of navigating GxP regulations to ensure compliance and reliable results in your laboratory operations. As a trusted partner, we specialize in enhancing compliance and ensuring the integrity of your GxP processes.GxP regulations encompass Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Manufacturing Practices (GMP). Rescop has the expertise to guide you through these intricate regulations, ensuring that your laboratory operations align with the highest industry standards.

Compliance is at the core of our services. We work closely with your team to develop customized strategies that address the specific requirements of your laboratory and streamline your compliance efforts. With Rescop as your partner, you can confidently navigate the complexities of GxP regulations.

 

Why choose Rescop?

Regulatory Expertise

Rescop possesses in-depth knowledge and expertise in GxP regulations governing laboratory operations. We stay updated with the latest regulatory requirements to ensure your laboratory remains compliant and aligned with industry standards.

Tailored Validation Solutions

We understand that each GxP laboratory has unique requirements. Rescop offers customized validation solutions designed to address your specific needs, ensuring a comprehensive and efficient validation process.

Compliance Excellence

Rescop is committed to helping you achieve and maintain compliance excellence. Our validation services and expertise enable you to navigate complex regulations, implement best practices, and mitigate compliance risks effectively.

Comprehensive Validation Services

Rescop offers a wide range of validation services, including equipment and instrument validation, process validation, software validation, data integrity assessment, and more. Our comprehensive approach ensures all critical aspects of your laboratory operations are thoroughly validated.

 

Quality-Focused Approach

Quality is paramount in GxP laboratories. Rescop's validation services emphasize the establishment and maintenance of robust quality management systems, ensuring accurate and reliable results while adhering to GxP regulations.

By choosing Rescop as your GxP laboratory validation partner, you gain access to a dedicated team of experts committed to your success. We work closely with you to understand your specific needs and objectives, providing customized validation plans and executing validation activities with precision and rigor.

 

Here are some of the activities Rescop can support clients with Medical devices:

  • Equipment and Instrument Validation: Validating laboratory equipment and instruments to ensure accuracy, precision, and compliance with regulatory requirements.
  • Process Validation: Assessing and validating critical laboratory processes to ensure reproducibility, reliability, and compliance with GxP regulations.
  • Software Validation: Validating laboratory software systems to ensure functionality, security, and compliance with regulatory standards.
  • Data Integrity Assessment: Conducting assessments to ensure the integrity, reliability, and security of laboratory data throughout its lifecycle.
  • Test Script Development and Execution: Developing and executing test scripts and protocols to verify the performance and compliance of laboratory processes and systems.
  • Change Control Management: Assisting in managing change control processes to ensure controlled and compliant changes within the laboratory environment.
  • Supplier Validation: Validating suppliers and their processes to ensure the quality and compliance of materials and components used in the laboratory.
  • Training and Education: Providing training programs and workshops to enhance the knowledge and skills of laboratory personnel in GxP regulations, validation processes, and quality management.
  • Validation Reporting: Preparing comprehensive validation reports summarizing the validation activities, results, and conclusions to demonstrate compliance and regulatory adherence.
  • Compliance Audits: Conducting audits to assess laboratory compliance with GxP regulations and identifying areas for improvement.