GxP Compliance Simplified: Focus on Innovation, Not Regulations.
Simplified Compliance with CaDP-IDE for AI: Focus on Innovation, Not Regulations.
Streamline GxP processes, reduce costs, and achieve continuous compliance with HCTI's GxP Ops Service.
At HCTI, we understand the challenges life sciences companies face with GxP compliance. Unforeseen expenses and ongoing audits can strain resources. Our GxP Ops Service offers a comprehensive solution to simplify compliance and empower your team. Compliance with GxP standards is crucial for ensuring patient safety, maintaining product quality, achieving regulatory compliance, and preserving a positive reputation with regulatory bodies, healthcare professionals, and patients. It is important to recognize that GxP compliance is a legal requirement for pharmaceutical companies in many countries. Failure to adhere to these standards can result in regulatory sanctions, fines, or even the suspension of operation
- Maximize Efficiency: Streamlined processes and tailored solutions save you time and money.
- Reduce Costs: Predictable fixed-fee model eliminates budgeting surprises.
- Focus on Innovation: Dedicate your team’s efforts to groundbreaking research and development.
- Continuous Compliance: Maintain compliance with regulatory requirements for electronic records and e-signatures by adhering to US FDA 21 CFR Part 11 and EMA EudraLex Annex 11. Uphold privacy standards as required by HIPAA, GDPR, and local regulations. Additionally, ensure alignment with industry standards such as NIST, HITRUST, and SOC for IT platforms and operating environments. Reduce risks through continuous support and constant monitoring.
- Peace of Mind: Gain confidence knowing your operations meet all regulatory requirements.
Key Offerings
Fixed Fee Model
Transparent pricing for budget certainty.
Customized Solutions
Services tailored to your specific application needs.
Regular and long-term support (LTS) release cycles for the lifecycle of the applications.
Flexible Application Lifecycle Enterprise Governance, Change & Incident Management
Scalable governance to manage users, apps, stations, change and incidents to mirror your frontline operations.
GxP Expertise
Leverage the knowledge and experience of our GxP specialists with compliance certifications and attestations against frameworks such as RAPS, PCI DSS, ISO, CSA STAR CCM, HITRUST CSF, and SOC 1 and 2.
Experienced Compliance Professionals Available:
Our team of experts is ready to ensure your organization meets all regulatory requirements efficiently. Leverage their extensive knowledge to navigate complex compliance situations with confidence.
Ongoing Support
Reduce time to provision, configure, and test a GxP compliance infrastructure, apps to maintain a continuously validated state.
GxP Compliance Management Platform
Partnered with industry leaders, our GxP Compliance Management Platform is a comprehensive digital solution designed to support organizations in regulated sectors such as pharmaceuticals, medical devices, and food production in maintaining compliance with Good Practices (GxP) regulations.
Key features of our GxP Compliance Management Platform include:
- Quality Management Systems (QMS): Manage and maintain quality across various processes, including raw material testing, process documentation, quality checks, and personnel training.
- Documentation and Record-Keeping: Tools for maintaining detailed and accurate records of all activities, changes, and validations, essential for traceability and compliance.
- Training and Personnel Qualifications: Ensure all personnel are adequately trained and qualified for their roles through the development and implementation of comprehensive training programs.
- Risk Management: Identify, assess, and mitigate risks associated with non-compliance using our robust risk management tools.
- Auditing: Conduct and manage internal and external audits for GxP compliance with our integrated auditing tools.
Our solutions offer unmatched reliability and efficiency, enabling you to achieve regulatory compliance seamlessly while focusing on your core business operations. Experience reduced risk, enhanced productivity, and peace of mind with our industry-leading expertise and advanced technology.
- Understanding of GxP Regulations: Our experts are available to support your platforms and systems, ensuring ongoing GxP compliance. We possess a deep knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Distribution Practice (GDP), Good Documentation Practice (GDocP), and other relevant guidelines.
- Experience in the Pharmaceutical Industry: We have a practical understanding of the processes and challenges faced in the pharmaceutical and life sciences industries.
- Quality Management, Documentation, and Record-Keeping: Maintaining detailed and accurate records of all activities, changes, and validations is crucial for traceability and compliance.
- Personnel Qualifications: Ensuring all personnel are adequately trained and qualified for their roles is a key aspect of GxP compliance. We support the development and implementation of comprehensive training programs.
- Risk Management Skills: Our team excels in identifying, assessing, and mitigating risks associated with non-compliance.
- Risk Management Skills: Our team excels in identifying, assessing, and mitigating risks associated with non-compliance.
Get a free consultation to discuss your specific GxP compliance needs.
Streamline GxP processes, reduce costs, and achieve continuous compliance with HCTI's GxP Ops Service.
At HCTI, we understand the challenges life sciences companies face with GxP compliance. Unforeseen expenses and ongoing audits can strain resources. Our GxP Ops Service offers a comprehensive solution to simplify compliance and empower your team. Compliance with GxP standards is crucial for ensuring patient safety, maintaining product quality, achieving regulatory compliance, and preserving a positive reputation with regulatory bodies, healthcare professionals, and patients. It is important to recognize that GxP compliance is a legal requirement for pharmaceutical companies in many countries. Failure to adhere to these standards can result in regulatory sanctions, fines, or even the suspension of operation
- Maximize Efficiency: Streamlined processes and tailored solutions save you time and money.
- Reduce Costs: Predictable fixed-fee model eliminates budgeting surprises.
- Focus on Innovation: Dedicate your team’s efforts to groundbreaking research and development.
- Continuous Compliance: Maintain compliance with regulatory requirements for electronic records and e-signatures by adhering to US FDA 21 CFR Part 11 and EMA EudraLex Annex 11. Uphold privacy standards as required by HIPAA, GDPR, and local regulations. Additionally, ensure alignment with industry standards such as NIST, HITRUST, and SOC for IT platforms and operating environments. Reduce risks through continuous support and constant monitoring.
- Peace of Mind: Gain confidence knowing your operations meet all regulatory requirements.
Key Offerings
Fixed Fee Model
Transparent pricing for budget certainty.
Customized Solutions
Services tailored to your specific application needs.
Regular and long-term support (LTS) release cycles for the lifecycle of the applications.
Flexible Application Lifecycle Enterprise Governance, Change & Incident Management
Scalable governance to manage users, apps, stations, change and incidents to mirror your frontline operations.
GxP Expertise
Leverage the knowledge and experience of our GxP specialists with compliance certifications and attestations against frameworks such as RAPS, PCI DSS, ISO, CSA STAR CCM, HITRUST CSF, and SOC 1 and 2.
Experienced Compliance Professionals Available:
Our team of experts is ready to ensure your organization meets all regulatory requirements efficiently. Leverage their extensive knowledge to navigate complex compliance situations with confidence.
Ongoing Support
Reduce time to provision, configure, and test a GxP compliance infrastructure, apps to maintain a continuously validated state.
GxP Compliance Management Platform
Our team of experts is ready to ensure your organization meets all regulatory requirements efficiently. Leverage their extensive knowledge to navigate complex compliance situations with confidence.
Key features of our GxP Compliance Management Platform include:
- Quality Management Systems (QMS): Manage and maintain quality across various processes, including raw material testing, process documentation, quality checks, and personnel training.
- Documentation and Record-Keeping: Tools for maintaining detailed and accurate records of all activities, changes, and validations, essential for traceability and compliance.
- Training and Personnel Qualifications: Ensure all personnel are adequately trained and qualified for their roles through the development and implementation of comprehensive training programs.
- Risk Management: Identify, assess, and mitigate risks associated with non-compliance using our robust risk management tools.
- Auditing: Conduct and manage internal and external audits for GxP compliance with our integrated auditing tools.
Our solutions offer unmatched reliability and efficiency, enabling you to achieve regulatory compliance seamlessly while focusing on your core business operations. Experience reduced risk, enhanced productivity, and peace of mind with our industry-leading expertise and advanced technology.
- Understanding of GxP Regulations: Our experts are available to support your platforms and systems, ensuring ongoing GxP compliance. We possess a deep knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Distribution Practice (GDP), Good Documentation Practice (GDocP), and other relevant guidelines.
- Experience in the Pharmaceutical Industry: We have a practical understanding of the processes and challenges faced in the pharmaceutical and life sciences industries.
- Quality Management, Documentation, and Record-Keeping: Maintaining detailed and accurate records of all activities, changes, and validations is crucial for traceability and compliance.
- Personnel Qualifications: Ensuring all personnel are adequately trained and qualified for their roles is a key aspect of GxP compliance. We support the development and implementation of comprehensive training programs.
- Risk Management Skills: Our team excels in identifying, assessing, and mitigating risks associated with non-compliance.
- Risk Management Skills: Our team excels in identifying, assessing, and mitigating risks associated with non-compliance.