Our Services
Comprehensive support through all stages of your facility’s life cycle.
Industry Standards & Guidelines
Our years in the field have made us experts on meeting and exceeding industry, national, and global standards of quality.
ICH Standards
International Council for Harmonisation guidelines ensuring global scientific and technical quality.
ASTM Standards
American Society for Testing and Materials technical standards for systems, products, and services.
The U.S. Code of Federal Regulations
Codification of general and permanent rules published by the executive departments and agencies of the federal government.
Quality Standards Development
We’ll work with you to hold your facility’s operations and product to the highest quality standards, consistently.
Revalidation Programs
Scheduled re-evaluation of systems to ensure they remain in a validated state.
Validation Project Plans
Strategic documents outlining the scope, approach, and schedule for validation activities.
IQ/OQ/PQ Protocols
Installation, Operational, and Performance Qualification protocols verifying equipment works as intended.
Risk Management
Systematic application of management policies to analyze, control, and monitor quality risks.
CAPA and Deviations Management Programs
Corrective and Preventive Action systems to investigate and solve quality issues.
Environmental Monitoring Programs
Surveillance of manufacturing environments to control microbial and particulate contamination.
Calibration and Maintenance Programs
Routines ensuring instruments measure accurately and equipment functions reliably.
Quality Control Program
Procedures ensuring manufactured products adhere to defined quality criteria.
Qualification & Validation Services
We’ll be right alongside you on your manufacturing floor, helping to make your processes and equipment run smoothly.
Commissioning/Decommissioning (FEU, QC Lab)
Verification that facilities, equipment, and utilities are installed and functioning correctly or safely retired.
IQ/OQ/PQ Execution and Support
Hands-on execution of qualification protocols to verify equipment performance.
Thermal Temperature Mapping Studies
Analysis of temperature distribution in storage areas to ensure product safety.
Cleaning Validation
Documented evidence that cleaning procedures remove residues to predetermined levels.
QC Lab Validation
Validation of laboratory instruments and methods used for quality control testing.
Relative Cleanability Coupon Validation
Testing surface materials to determine how easily they can be cleaned.
Risk Assessment Facilitation and Execution
Leading workshops to identify and mitigate potential process or quality risks.
Supplier/Vendor Assessments and GMP Compliance Audits
Evaluating external partners to ensure they meet Good Manufacturing Practice standards.
Gap Analysis and Remediation
Identifying discrepancies between current systems and regulatory requirements, and fixing them.
Environmental Monitoring Sampling
Collection and analysis of air and surface samples to monitor cleanliness.
Disinfectant Studies
Testing to verify the efficacy of disinfectants used in the facility.
GMP Training Services
Educational programs to ensure staff are knowledgeable about Good Manufacturing Practices.
Process Validation and Scale-Up
Establishing scientific evidence that a process is capable of consistently delivering quality product.
Deviations, Change Control and CAPA Management
Handling unexpected events, managing changes, and implementing corrective actions.
Analytical Methods Development
Creating and validating techniques for analyzing products and raw materials.
Shipping Validation
Verifying that product integrity is maintained during transport and distribution.
Facilities & Engineering
We’ll provide skilled engineering support and guidance through all stages of your facility’s technical operation.
Requirements Trace Matrix
A document linking requirements to their tests, ensuring all needs are met and verified.
Design Qualification
Verification that the proposed design of facilities and equipment is suitable for the intended purpose.
Reliability Engineering
Engineering focused on the dependability and lifecycle management of systems.
AutoCAD Support (P&ID Drafting and Editing)
Technical drafting services for Piping and Instrumentation Diagrams and facility layouts.
Engineering Design Review
Critical evaluation of engineering designs to identify issues before construction.
Hazard Review
Systematic assessment of potential safety and process hazards.
Generation of User and Functional Requirement Specifications
Documenting exactly what the user needs and how the system should function.
SOP Generation
Writing Standard Operating Procedures to ensure consistent performance of tasks.
System Impact Assessment Generation
Determining which systems have a direct impact on product quality.
Project Management & Documentation
We’re detail oriented, but a big-picture perspective is just as crucial to a smooth operation.
Project Management (Construction, Commissioning, Validation, Engineering)
Overseeing timeline, budget, and resources for complex technical projects.
Document Management Program Development
Creating systems for the creation, approval, and storage of GxP documents.
Document Management Services
Ongoing administration and organization of critical project and quality documentation.
IT Services
We’ll make sure your IT infrastructure and standards are stable, secure, efficient, and up-to-date.
Data Back-Up and Migration
Securely saving data and transferring it between systems without loss.
Hardware and Software Configuration Support
Setting up and optimizing IT assets for compliant operation.
Connectivity Troubleshooting
Diagnosing and fixing network and communication issues between systems.
User Software Account Management
Administering user access and permissions in compliance with data integrity rules.
Schedule a Consultation
Ready to improve your validation process? Get in touch with our experts.