Compli’s experts are experienced in all facets of equipment qualification. We utilize a cross-functional team to develop documents that meet your unique requirements.

Our experience includes:

We have experience with the qualification of a wide range of process equipment.

Compli has the technical expertise in performing facility qualifications including:

• Cleanroom Classification (FDA, EU, ISO)
  • Environmental Monitoring (Non-viable and Viable)
  • Recovery testing
  • Air Flow Velocities and Visualization
  • Room Finishes
  • TAB Review
  • Differential Pressure/Temperature/Relative Humidity
• Pass-throughs
• Interlocks
• Security Systems

Compli supports every stage of the Process Validation process. Our team of Process Validation experts are well-versed in the FDA Process Validation Guidance Document and relevant EU guidelines, enabling them to assist in the implementation of Stages 1, 2, and 3.

Compli has the capacity to provide comprehensive support in the development and qualification of your Clean-In-Place (CIP) or Sterilization-In-Place (SIP) processes, ensuring they meet the necessary standards and requirements. 

Our experts perform the following services:

• CIP cycle development and execution
• SIP cycle development and execution
• Cleaning Validation Master Plan
• Cleaning Validation protocol development and execution
• Clean, Dirty and Sterile Hold Time Validation

Our Computer System Validation Specialists have in-depth knowledge of regulatory requirements and best practices, ensuring that your systems are not only compliant, but also operate effectively and reliably.

Compliance with 21 CFR Part 11 is vital for ensuring the integrity and reliability of electronic records and signatures. This regulation mandates system validation, secure audit trails, access controls, data integrity safeguards, and identity verification procedures. It is essential for industries under FDA regulation to maintain electronic record integrity. Our team of proficient experts specializes in Computer System Validation (CSV) according to 21 CFR Part 11 and data integrity principles.

We provide comprehensive assistance in creating and implementing Computerized System Validation protocols for various systems including:

• ERP Systems (SAP, CMMS)
• BMS/BAS (Building Management Systems/Building Automation Systems
• PCS/DCS/SCADA (Process Control Systems/Distributed Control Systems/Supervisory Control and Data Acquisition)
• MES (Manufacturing Execution Systems)
• QAS (Quality Assurance Systems)
• LIMS (Laboratory Information Management Systems)
• PLCs (Programmable Logic Controllers)

Computer systems used to create, modify, and maintain electronic records and manage electronic signatures are subject to validation requirements to ensure accuracy, reliability and intended performance. The ability to discern invalid or altered records is the fundamental challenge facing life science companies.

Data Integrity reviews are necessary to ensure that record integrity exists throughout the entire life cycle of a given system. Risks should be properly identified and remediated to reduce the potential to affect product quality and patient safety.

We will work with you to review your existing validation procedures, system specifications, and documentation to identify any gaps. Working together we’ll define remediation activities and develop a training approach to ensure maintenance of compliance for the future.

Our experts perform the following services:

•  21 CFR Part 11 Review
• Data processing and record retention requirements
• Existing Validation Process Review
• System Backup and Recovery Process
• IT Risk Assessment
• Information Security Assessment
• Technical User Requirements
• GAP remediation
• Training

Compli offers a comprehensive suite of analytical method validation services, ensuring that clients in regulated industries achieve the highest standards of accuracy, reliability, and compliance in their analytical processes. Our services align with regulatory requirements such as the U.S. Food and Drug Administration (FDA) and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Here’s an overview of the analytical method validation requirements that Compli addresses:

• Accuracy and Precision: Compli’s validation process meticulously evaluates and establishes the accuracy and precision of analytical methods, providing clients with assurance in the reliability of their measurement results.
• Specificity and Selectivity: Our validation protocols rigorously assess the specificity and selectivity of analytical methods, ensuring accurate identification and quantification of target analytes in the presence of potential interfering substances.
• Linearity and Range: Compli’s approach includes a thorough examination of the linearity of analytical methods, ensuring a robust relationship between measured responses and analyte concentrations over a specified range.
• Limit of Detection (LOD) and Limit of Quantification (LOQ): We determine and validate the LOD and LOQ, establishing the sensitivity of the method to reliably detect and quantify low concentrations of analytes.
• Robustness: Compli places emphasis on the robustness of analytical methods, evaluating and addressing variations in method parameters to ensure consistent performance across diverse conditions.
• System Suitability: Our validation criteria encompass system suitability assessments, ensuring that the analytical system meets predefined performance criteria related to resolution, peak symmetry, and retention time.
• Accuracy in Sample Preparation: Compli’s validation process accounts for factors related to sample preparation, ensuring the accuracy of analyte recovery from complex sample matrices.
• Documentation and SOPs: Clients benefit from comprehensive documentation, including validation protocols and reports, as well as clear Standard Operating Procedures (SOPs) developed by Compli to ensure the reproducibility and traceability of analytical methods.
• Validation Parameters: Compli tailors its validation approach to cover various parameters, including precision, accuracy, linearity, robustness, and system suitability, in accordance with the unique requirements of each analytical method and relevant regulatory guidelines.
• Lifecycle Management: Compli emphasizes the importance of ongoing monitoring and verification throughout the lifecycle of analytical methods, providing clients with a dynamic approach to maintaining the suitability and reliability of their methods.

With Compli’s analytical method validation services, clients can confidently navigate regulatory landscapes, ensuring the integrity of their analytical processes and the production of high-quality, compliant products.

Compli boasts an in-depth understanding of the validation lifecycle, continuously enhancing our proficiency by staying up-to-date with the latest regulations, guidance, and best practices. Establishing, executing, and sustaining a robust validation quality system is imperative for ensuring compliance and streamlining validation initiatives across an organization. The adoption of a risk-based qualification program can result in increased efficiency while upholding stringent compliance standards.

Compli can support in developing or modifying:

• Validation Master Plans
• Validation Project Plans
• Corporate Guidance Documents
• Validation SOPs
• Validation Best Practices
• Risk Assessments and System Classification

Compli also has in-house Project Managers who can assist with project scheduling and budgeting. Our Project Managers are skilled in several project planning resources including Microsoft Project and SmartSheet. We accurately plan, budget, and forecast projects.

Compli can support electronically-based documentation systems and has experience with:

• MasterControl
• TrackWise
• Veeva Systems
• ValGenesis
• Kneat

Compli has a wide offering of Validation support services to ensure the smooth and compliant operation of your processes and systems.

These services include:

• SOP Development
• Training
• Deviation Management
• Change Control
• Documentation Management
• Batch Record Review
• Vendor Audits
• Facility System and Design Review