Our Services

CAVE Solutions, Inc is a professional consulting firm specializing in the technical and commercial aspects of compliant services. Since its inception, CAVE has provided the industry with reliable databases, guides, and models for cross-functional organization and controls. We maintain a Downstream Lens to protect the patient and product quality.

CAVE’s integrated system to manage compliance data allows seamless transitioning through all stages of the process: Construction, Automation, Validation and Engineering come together to form CAVE Solutions.

Our team members bring deep, industry-tested experience in all aspects of pharmaceutical regulation:

• Business evaluation
• Process modeling
• Technical design
• Construction
• Facility release
• First-in-kind
• Equipment reliability
• Plant optimization.

Get more done with less resources. We’ve identified and onboarded the experts necessary to bring your project to a smooth, predictable finish. Our flexible organization, value-add mindset, analytical strength, and highly skilled consultants allow us to invest upfront, organize upstream activities, and deliver defined, reliable outcomes.

CAVE Solutions is an end-to-end provider of startup and qualification of GMP systems and facilities. No two ecosystems are the same, so we structure and organize the diversity of trades, vendors, and client-side inputs to reduce time to market. Our project methodologies assess business and compliance risk to create the framework for a smooth project transition through the validation hourglass.

Our project execution focuses on fulfilling URS requirements through stewardship of upstream deliverables, and identification and management of stage-gate inputs and timelines.

Our project management methodologies maximize project efficacy and efficiency through a planned timeline. This includes:

• Identifying and assessing business and compliance risks
• Outlining project controls
• System definition
• Collective arrangement of blended disciplines
• Engineering change management
• Managing turnover and detailed validation planning

The Downstream Lens is a unique component of CAVE Solutions’ method. It includes 6 steps, each broken down into smaller substages.

Chartering
Preliminary activities to assess business and compliance risks

• Overall Project Planning
• CX Planning
• Automation Network Design
• Panel Design
• System Assessments
• User Requirement Spec.
• Functional Spec.
• Design Spec.

Basis of Design
Project and Quality Planning provides the framework and tools for smooth project execution

Detailed Design
Develop system-level risk assessment to concentrate Quality’s involvement in areas critical to patients and product quality

Develop platform strategies to align Qualification with Construction prior to QMS implementation

Construction
Outline Commissioning Strategy to arrange trade turnover timing to release systems and “Specifications to System”

Commissioning
Robust engineering change management for enhanced efficiency and full compliance

Qualification

• IQ – Confirmation and verification of proper installation through Quality programs
• OQ – Focused testing on equipment operating parameters and sequential operations
• PQ – Focused testing on CPP and critical manufacturing process aspects

As manufacturers transition from paper to paperless records and computerized systems as a way to better keep track of all the data that can be accumulated during the manufacture, testing and release of a product. If you have any computerized systems or electronic records on site you’ll have to comply with the regulatory requirements for Electronic Records and Electronic Signatures (ERES) as outlined in the US Code of Federal Regulations (CFR) Part 11, or those documented in EU or PIC/S Annex 11.

If you are considering a new computer system and are not sure if it’s suitable or not, we can review it against the current regulatory requirements to ensure it is compliant before you start implementation (or before you commit to purchasing and sign any contracts!).

If you have an existing system and you aren’t sure if it needs to be compliant or if it even can be made to be, we’ll review it and recommend any remediation actions that may be required in order to comply with the 21 CFR Part 11 or PIC/S Annex 11 requirements.

A common mistake is to ignore the predicate rules and incur unnecessary expense doing work that that is not required. It is still common to see over-elaboration on this requirement.

Putting the systems and documentation in place

During our work on Part 11 compliance with our customers, we’ve developed robust procedures and assessment templates for this area. We’ll ensure that you have the correct documentary evidence to ensure compliance with the CFR’s and regulatory requirements – making your next audit a success.

Laboratory Equipment

CAVE Solutions simplifies analytical equipment validation by standardizing your approach for determining data flow outputs. The combination of its GAMP categorization and data process map define the architecture for an efficient validation process.

Assessment Snapshot

GAMP categorization simplified through a series of definitions

Data Integrity profile simplified through a series of questions

Outcomes that were once complex are now linear.

The IT pillar of analytical validation

• Access Levels
• Access Rights
• Backup & Restore
• Audit Trail

Advanced Services

CAVE sees operations as a potential competitive advantage for our clients. To retain that advantage and advance our capabilities, we focus on reliability, efficiency, agility, and differentiation. Our suite of advanced services are designed to simplify your operation.

Custom Solutions Development

Our team collaborates closely with you develop and implement proven solutions that meet your unique challenges and objectives, ensuring that operations are

Quality Assurance and Compliance

We excel at simplifying the complexities of today’s regulatory environment and implementing pragmatic solutions across a wide range of technologies and risk mitigation strategies.

Precision in Practice, Excellence in Execution

In the realm of manufacturing sciences, the efficiency and reliability of technical operations are paramount. At Cave Solutions, we offer an extensive suite of Technical Operations services designed to ensure your manufacturing processes are optimized for both performance and reliability.

Operational Excellence: Our approach to technical operations focuses on continuous improvement and lean manufacturing principles, ensuring your operations are streamlined and cost-effective without compromising on quality.

Equipment and Facility Management: With meticulous attention to detail, we manage and maintain your manufacturing equipment and facilities, ensuring they operate at peak performance and comply with all regulatory standards.

Risk Management: We employ comprehensive risk management strategies to identify, assess, and mitigate potential risks in your operations, safeguarding your assets and ensuring uninterrupted production.

Technological Transfer

Bridging Innovation, Ensuring Success

Technological Transfer is a critical component of manufacturing sciences, ensuring that innovations and improvements are effectively integrated into manufacturing processes. Cave Solutions provides transfer support by providing the following services:

Fit for Use

We provide a fit for use evaluation platform integrated with our Knowledge Transfer process focusing on the four pillars of fit for use:

• Compliance with regulations
• Performance consistency
• Scalability
• Reliability

This includes proven methods of:

• Planning and Documentation
• Testing and Validation
• Training and Knowledge Transfer

This principle in technology transfers underscores the necessity of a holistic approach to ensure technologies and processes not only meet the predefined functional and regulatory requirements but also maintain their integrity and performance across different manufacturing contexts. This principle is integral to the successful commercialization of pharmaceutical products.

Operational Readiness

The comprehensive preparation and validation process that ensures all systems, processes, personnel, and facilities at the receiving site are fully equipped and capable of executing the transferred technology or process efficiently, effectively, and in compliance with all regulatory requirements before the commencement of full-scale production or clinical manufacturing. It is a critical phase in the technology transfer process, aiming to mitigate risks, ensure product quality, and maintain supply chain continuity.

Our Vision for Operational Readiness Includes:

1. Facility and Equipment Preparation:

Ensuring that the physical infrastructure, including manufacturing facilities and equipment, is appropriately designed, installed, qualified, and validated to handle the new process.

2. Process Validation

Conducting a thorough validation of the transferred process to demonstrate that it performs consistently within the defined parameters and produces products that meet all predetermined quality criteria.

3. Quality Systems Integration

Integrating and aligning the quality management systems (QMS) between the transferring and receiving sites, ensuring that all necessary quality controls, documentation practices, and regulatory compliance measures are in place and operational. This includes standard operating procedures (SOPs), change control systems, and deviation management processes.

4. Supply Chain and Materials Readiness

Securing the supply chain for all raw materials, intermediates, and critical components required for the technology or process, ensuring they meet quality specifications and are available in sufficient quantities to support uninterrupted production schedules.

Assessing Operational Readiness

We assess operational readiness through a structured reviews using checklists, audits, and readiness reviews conducted by cross-functional teams, including representatives from manufacturing, quality assurance, engineering, regulatory affairs, and other relevant departments. This assessment ensures that:

• All critical systems and processes have been validated.
• Personnel are adequately trained and competent.
• Quality and compliance systems are fully functional.

The site is ready to commence production or clinical manufacturing without compromising product quality or compliance.

Elevate your manufacturing operations with our comprehensive suite of services, designed to ensure Good Manufacturing Practice (GMP) compliance and adeptly manage unassessed risks.

Tailored solution to safeguard your manufacturing processes.

• Swift closure of existing compliance gaps
• Risk reduction for regulatory issues
• Streamlined and compliant operational processes

Customized Approach for quality management systems, risk management plans, continual improvement programs, and root cause analysis ensure proactive risk mitigation aligned with industry standards.

GMP Compliance and Remediation Services:

• GMP Audits: Conducting comprehensive audits to assess existing compliance gaps, including SOPs, batch records, and validation protocols.
• Documentation Review: Optimization of SOPs, batch records, and protocols for seamless GMP adherence.
• Training Programs: Tailored GMP training programs for staff at various levels to enhance awareness and correct deviations in GMP practices.

Additional Focus on Risk Management:

• Quality Management Systems: Restructuring and improving QMS processes for better compliance.
• Gap Analysis: Conducting thorough assessments to identify areas of non-compliance.
• Corrective and Preventive Action (CAPA) Plans: Developing and implementing CAPA plans to rectify issues and prevent recurrence.
• Regulatory Compliance Assistance: Guidance and support for regulatory requirements and inspections.

Transform your existing GMP facility. Contact us to discuss tailored remediation solutions and elevate your compliance standards.

Data Integrity (DI), whether paper or electronic, is relevant for anyone recording information in controlled GxP systems.

Facilities must be able to collect, analyze, report and retain data that is accurate, truthful and complete. GDPs for computerized systems are incorporated into the validation using ALCOA+ principles. Reconstruction of data process activities must be Complete, Consistent, Enduring and Available.

CAVE Solutions provides a systematic approach that takes a complex combination of outcomes and organizes it through a series of elementary steps.

Assess for GXP impact

• Direct
• Not Direct

Access for GAMP Categorization

• Category 1 – Infrastructure
• Measuring Device
• Category 3 – Non-Configurable
• Category 4 – Configurable Software
• Category 5 – Custom Software

Assess for Data Integrity Profile

• Profile A – Paper Records
• Profile B – System Controls
• Profile C – System of Record
• Profile D – Transitory
• Profile E – Interfacing

Assess for Electronic Record / Electronic Signature

Assess for Audit Trail

Standardize life-cycle documentation for each GAMP Categorization

Standardize Data Integrity requirements for each profile

Standardize testing for each Data Integrity requirement

Welcome to CAVE Solutions, where excellence in quality management services meets a commitment to collaboration and client-centric solutions. With our extensive database of resources and expertise in technical writing, policy development, procedures, Standard Operating Procedures (SOPs), and work instructions, we go beyond traditional approaches to deliver a tailored experience that reflects our unique way of working.

At CAVE Solutions, we understand that effective quality management requires more than just documentation – it demands a holistic approach that brings together diverse perspectives, blended disciplines, and deep engagement with the clients we serve. Our team of experienced technical writers excels not only in crafting clear, concise, and actionable policies but also in fostering an environment of collaboration that ensures your organization's success.

Our way of working goes beyond the ordinary, emphasizing collaboration and a deep understanding of your unique needs. We don't just create policies, procedures, and SOPs; we co-create solutions with you. By leveraging our database of resources, which includes templates, guidelines, and proven methodologies, we facilitate a seamless integration of diverse viewpoints, ensuring that your quality management system reflects the richness of your organization.

From the inception of defining quality objectives to the execution of risk assessments and audits, CAVE Solutions is your partner in driving continuous improvement. Our commitment to deep engagement means that we work closely with your team to not only meet industry standards but to exceed them.

Experience the power of collaboration, where diverse perspectives and blended disciplines converge to shape a quality management system uniquely tailored to your organization. Contact us today to learn more about how CAVE Solutions, can help you optimize your processes, enhance your documentation, and achieve excellence in quality management.

CAVE Solutions inc. - Empowering Excellence, Ensuring Quality, Together.

At CAVE Solutions we bring a unique blend of project management expertise, in-depth industry knowledge, and hands-on experience to the forefront of automation solutions tailored for Good Manufacturing Practice (GMP) facilities. As a dedicated partner, we take pride in seamlessly integrating cutting-edge technology with our robust project management methodologies.

Project Management Excellence
Our seasoned team excels in project management, ensuring that every facet of your automation initiative is meticulously planned, executed, and monitored. We navigate complexities with finesse, adhering to timelines and budgetary considerations to deliver solutions that exceed expectations.

In-Depth Industry Knowledge
Backed by a profound understanding of GMP regulations and industry best practices, we tailor our automation services to align perfectly with your operational and compliance requirements. Our knowledge is not just theoretical; it's a practical application gained through successful implementations in diverse GMP environments.

Hands-On Experience
What sets us apart is our hands-on experience in managing automation projects for GMP facilities. We've been at the forefront of designing and implementing solutions that optimize processes, enhance productivity, and ensure adherence to the highest quality standards.

Explore our services below to discover how we can enhance your operational excellence, ensure data integrity, and navigate the complexities of GMP compliance. At CAVE Solutions, we don't just provide services; we deliver solutions that drive success in your industry.

• • Process Automation:
    Implement automated control systems for precise monitoring and regulation of manufacturing processes.
  • SCADA Systems:
    Real-time monitoring and control with SCADA systems, enabling remote access and data visualization.
  • Batch Control Systems:
    Automated batch processing for consistent and repeatable production, integrated with recipe management.
  • MES Solutions:
    Bridge ERP and shop floor operations with Manufacturing Execution Systems for real-time tracking and optimization.
  • Cleanroom Automation:
    Tailored automation solutions for cleanroom environments, integrating HVAC, environmental monitoring, and access control.
  • Data Integrity and Compliance:
    Implement systems for data integrity and GMP compliance, featuring audit trails, electronic signatures, and validation documentation.
  • Robotics and Automation:
    Integrate robotics to streamline material handling, packaging, and repetitive tasks, reducing manual intervention.
  • Instrumentation and Control Systems:
    Upgrade and maintain instrumentation and control devices, ensuring accurate measurement and control.
  • LIMS Integration:
    Integrate with Laboratory Information Management Systems for streamlined data management in laboratory processes.
  • Cybersecurity Solutions:
    Implement robust cybersecurity measures to protect automation systems from cyber threats.
  • Training and Support:
    Provide training programs for operators, maintenance personnel, and ongoing support services.
  • Remote Monitoring and Diagnostics:
    Enable remote monitoring and diagnostics for proactive issue resolution and predictive maintenance.
  • Continuous Improvement:
    Regular assessments and continuous improvement initiatives based on data-driven insights for optimization.

At CAVE Solutions, we go beyond traditional Chemistry, Manufacturing, and Controls (CMC) services, creating an environment that embraces diverse perspectives, blends disciplines, encourages open exchange, and fosters deep engagement with the clients we serve. Our commitment to excellence extends beyond technical expertise, bringing innovation and collaboration to the forefront of pharmaceutical development and manufacturing.

Our Collaborative CMC Services:

Chemistry (C):

• In-depth characterization of drug substances (APIs).
• Impurity identification and analysis.
• Development and validation of analytical methods.

Manufacturing (M):

• Formulation development and optimization.
• Process scale-up and commercial production support.
• GMP-compliant manufacturing processes.

Controls (C):

• Rigorous quality control testing.
• Stability testing and monitoring.
• Batch testing and validation of analytical methods.

Why Collaborate with CAVE Solutions?

• Diverse Perspectives: Our way of working thrives on diverse perspectives, bringing together experts from various disciplines to approach challenges creatively.
• Discipline Blending: We seamlessly blend different disciplines, fostering innovation and ensuring a holistic approach to pharmaceutical development.
• Open Exchange: An open exchange of ideas is at the heart of our collaborative culture, creating an atmosphere where innovation and efficiency flourish.
• Deep Engagement: We deeply engage with our clients, understanding their unique needs and challenges, to provide tailored solutions that drive success.

Whether you are a startup or an established industry player, CAVE Solutions is more than a service provider – we are your collaborative partner in achieving pharmaceutical excellence. Explore our website to learn more about how our collaborative approach sets us apart in the CMC services landscape.

We’re a Trusted Kneat Services Partner. As a Kneat Services Partner we’re qualified to map and configure your work processes to Kneat Gx, to scale these processes across your various sites and provide ongoing support to your users. Kneat Solutions’ feature rich paperless validation platform, Kneat Gx makes validation easier, faster and smarter. Purpose built for the Life Sciences, Kneat Gx digitizes your entire validation life-cycle, enabling validation teams to author, review, approve, test-execute, manage exceptions and post-approve any business process in a 21 CFR Part 11 compliant web based software that’s securely accessible anywhere with an internet connection.

In the dynamic landscape of Good Manufacturing Practice (GMP), maintaining the highest standards of quality is paramount. Our commitment to excellence extends beyond the production floor – it encompasses a comprehensive set of services designed to uphold GMP compliance, ensuring the safety, efficacy, and reliability of your products.

Discover the key elements that contribute to the success of GMP facilities, from stringent document control to robust training programs, thorough quality control, and continuous improvement initiatives. Explore how these quality services collectively create a foundation for producing pharmaceuticals and regulated products of the highest caliber.

Join us on a journey through the essential components that safeguard the integrity of your processes, foster a culture of excellence, and contribute to the overall success of your GMP facility.

Key Quality Services:

• • Document Control:
    Establish a robust system for managing manufacturing documents with version control.
  • Training Programs:
    Develop comprehensive training programs to ensure employee competence in GMP procedures.
  • QC and QA:
    Monitor and test raw materials and products; conduct regular audits to ensure GMP compliance.
  • Validation and Qualification:
    Validate equipment, processes, and systems to ensure consistency and reliability.
  • Change Control:
    Manage changes in facilities, equipment, and procedures to prevent adverse impacts on quality.
  • Cleaning:
    Implement effective cleaning programs to maintain a hygienic manufacturing environment.
  • Supplier Qualification:
    Assess and qualify suppliers to ensure quality and reliability of materials and services.
  • Complaint Handling and Investigation:
    Develop procedures for handling customer complaints and conduct thorough investigations.
  • Risk Management:
    Identify, assess, and mitigate potential risks to product quality and patient safety.
  • Data Integrity:
    Ensure the integrity and accuracy of data generated during manufacturing and testing.
  • Continuous Improvement:
    Foster a culture of continuous improvement to enhance processes, procedures, and systems.
  • Security and Access Control:
    Implement strict security measures and access controls to safeguard facilities and data.

Welcome to CAVE Solutions, where we specialize in comprehensive airflow visualization studies tailored to meet the unique needs of Good Manufacturing Practice (GMP) facilities. Our commitment to "Project Better, Together" is at the core of our services, combining focus service, strategic business solutions, and extensive life-science experience.

1. Facility Assessment:
Our experts collaborate with your team to conduct a thorough examination of your facility, identifying potential airflow issues, contamination risks, and areas for improvement. Together, we ensure your facility operates at its best.

2. Regulatory Compliance Checks:
Aligning your facility with the highest regulatory standards, such as Good Manufacturing Practices (GMP). Our collaborative approach focuses on maintaining a controlled environment that not only meets but exceeds industry regulations and guidelines.

3. Airflow Pattern Visualization:
Through collaborative smoke studies, we visually demonstrate airflow patterns within your facility. This shared effort identifies areas with poor ventilation, cross-contamination risks, and ensures the protection of critical processes.

4. Cleanroom Validation:
Our joint efforts extend to validating the effectiveness of your cleanrooms. We assess air distribution, filtration efficiency, and pressure differentials, maintaining the required cleanliness levels with a collaborative and focused approach.

5. Troubleshooting and Issue Resolution:
Together, we identify and address specific airflow issues, optimizing the performance of your facility. Our collaborative strategy ensures a consistent, controlled environment that aligns with your business goals.

6. HVAC System Optimization:
Collaboratively evaluating Heating, Ventilation, and Air Conditioning (HVAC) systems, we optimize performance with a focus on efficient air distribution. Our shared commitment maintains desired temperature and humidity levels for optimal operations.

7. Containment Studies:
Our collaborative approach extends to assessing containment systems, especially in facilities handling hazardous substances. We work together to prevent the spread of contaminants, protecting both products and personnel.

8. Emergency Response Planning:
Together, we develop emergency response plans based on airflow patterns, mitigating potential contaminant spread during facility emergencies or containment breaches.

9. Training and Education:
Collaboratively providing training sessions for facility personnel on the importance of airflow management, contamination control, and best practices. Together, we empower your team to maintain a controlled environment.

10. Documentation and Reporting:
Delivering comprehensive reports is a collaborative effort, outlining findings, recommendations, and action plans based on airflow visualization studies. Our shared documentation ensures compliance with industry standards and regulatory requirements.

At CAVE Solutions we believe in "Project Better, Together." Contact us today to discuss how our collaborative services, focus service, business strategy, and life-science experience can optimize your GMP facility's performance, ensuring a safe, controlled, and compliant environment.