Services 2020-01-09T03:56:46+00:00

OUR SERVICES

WE CARE BECAUSE YOU CARE

With more than 13 years of biotechnical and pharmaceutical experience under our belt, and comprehensive knowledge of industry standards and regulations, CERTUS is equipped with the expertise to provide support through all stages of your facility’s life cycle. No matter your operation scale, CERTUS will work with you to carefully and thoroughly assess your manufacturing facilities and processes, develop a perfectly tailored validation program for your unique FEU needs, and provide responsive support to ensure that the highest qualification standards are sustained from start to finish.

Industry Standards

& Guidelines

Our years in the field have made us experts on meeting and exceeding industry, national, and global standards of quality, including:

  • ICH Standards

  • ASTM Standards

  • The U.S. Code of Federal Regulations

Quality Standards

Development

We’ll work with you to hold your facility’s operations and product to the highest quality standards, consistently. Our internal guideline, protocol, and program-generation support includes:

  • Revalidation Programs

  • Validation Project Plans

  • IQ/OQ/PQ Protocols

  • Risk Management

  • CAPA and Deviations Management Programs

  • Environmental Monitoring Programs

  • Change Control Programs

  • Calibration and Maintenance Programs

  • Quality Control Program

Qualification & Validation Services

We’ll be right alongside you on your manufacturing floor, helping to make your processes and equipment run smoothly. The services we provide include:

  • Commissioning/Decommissioning

    • FEU
    • Quality Control Lab

  • IQ/OQ/PQ Execution and Support

    • Thermal Temperature Mapping Studies

  • Cleaning Validation

  • QC Lab Validation

  • Relative Cleanability Coupon Validation

  • Risk Assessment Facilitation and Execution

  • Supplier/Vendor Assessments and GMP Compliance Audits

  • Gap Analysis and Remediation

  • Environmental Monitoring Sampling

  • Disinfectant Studies

  • GMP Training Services

  • Process Validation and Scale-Up

  • Deviations, Change Control and CAPA Management

  • Analytical Methods Development

  • Shipping Validation

Facilities & Engineering

We’ll provide skilled engineering support and guidance through all stages of your facility’s technical operation, from planning to maintenance, including:

  • Requirements Trace Matrix

  • Design Qualification

  • Reliability Engineering

  • AutoCAD Support (P&ID Drafting and Editing)

  • Engineering Design Review

  • Hazard Review

  • Generation of User and Functional Requirement Specifications (Systems and Equipment)

  • SOP Generation

  • System Impact Assessment Generation

Project Management & Documentation

We’re detail oriented, but a big-picture perspective is just as crucial to a smooth operation. We’ll take your projects through start-up, validation, and commissioning with these services, and more:

  • Project Management

    • Construction
    • Commissioning
    • Validation
    • Engineering

  • Document Management Program Development

  • Document Management Services

IT Services

Your facility’s digital network is its nervous system, and it needs care, too. We’ll make sure your IT infrastructure and standards are stable, secure, efficient, and up-to-date with these areas of support:

  • Data Back-Up and Migration

  • Hardware and Software Configuration Support

  • Connectivity Troubleshooting

  • User Software Account Management

Schedule a Consultation