Our Services

We cater to your company’s needs, applying ICH guidelines to ensure risk-based, science-driven approaches throughout the validation lifecycle, aligning with global regulatory expectations for pharmaceutical and biotechnology manufacturing. This enables efficient, compliant commissioning and qualification while focusing resources on what truly impacts product quality, safety, and efficacy.

Our Team has authored risk-based Validation Master Plans, conducted multiple PHAs and QRAs for equipment such as bioreactors, fill lines, and clean utilities, and ensured URS for process gases (CO₂, N₂, O₂, CDA), clean steam, WFI, and HVAC systems meet ICH thresholds. This has supported successful commissioning and qualification of GMP facilities and laboratories with zero critical deviations.

CERTUS LLC leverages ASTM E2500 to streamline commissioning and qualification, shifting from traditional rigid IQ/OQ/PQ to a more flexible, risk-based verification approach that focuses on critical aspects of your process and equipment, thus accelerating project timelines while maintaining full regulatory compliance.

We have applied ASTM E2500 principles to commission and qualify multiple GMP facilities, including fill-finish suites, QC laboratories, and upstream/downstream process areas. This included leveraging commissioning data for HVAC, BMS, process gases, autoclaves, and bioreactors, resulting in reduced testing effort (often 30-35% savings) while delivering projects on aggressive timelines with full defensibility.

CERTUS LLC ensures all validation, commissioning, and qualification activities fully comply with 21 CFR requirements, incorporating good documentation practices (GDP), data integrity (ALCOA+), and robust quality systems to support successful FDA inspections and regulatory filings.

We have provided 21 CFR-compliant validation services for numerous GMP facilities and utilities, including authoring protocols for autoclaves, clean steam generators, WFI systems, HVAC/BMS, and bioreactors. This has included change control management, deviation resolutions, and summary report packages that supported successful commissioning and qualification with no critical or major regulatory findings.

We have successfully commissioned GMP facilities, utilities, and QC labs for numerous clients, including projects for fill-finish suites, warehouses, and cell banking areas, delivering on aggressive timelines. Decommissioning efforts have included safe shutdown of legacy systems during upgrades.

We offer comprehensive commissioning and decommissioning services for Facilities, Equipment, Utilities (FEU), and QC Laboratories, ensuring seamless startup, operational readiness, and safe shutdown while minimizing downtime and compliance risks. Services we provide include:

• Development and execution of commissioning plans, including Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and enhanced commissioning for utilities like HVAC, clean steam, WFI, process gases (CO₂, O₂, CDA), and equipment such as bioreactors, autoclaves, and stability chambers.
• Decommissioning support with impact assessments, risk evaluations, data archiving, and final reports to ensure regulatory compliance during facility closures or upgrades.
• Integration of risk-based approaches to leverage commissioning data into qualification, reducing redundant testing.

CERTUS provides end-to-end support for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, verifying that systems are installed correctly, operate as designed, and perform consistently under load. Services we provide include:

• Authoring, reviewing, and executing IQ/OQ/PQ protocols with clear test scripts, acceptance criteria, and traceability matrices. We have authored and executed IQ/OQ/PQ for a range of equipment and utilities, such as autoclaves, freezers, bioreactors, analytical instruments (e.g., Cedex Bio Analyzers, NovaFlex), and clean utilities (e.g., Purified Water (PW), Water for Injection (WFI), Clean Steam, and process gases (e.g., Nitrogen, Compressed Air, Carbon Dioxide, and Oxygen)) supporting successful qualifications at multiple GMP sites with efficient package turnover.
• On-site or remote execution support, including data collection, deviation investigations, and summary reporting.
• Risk-based optimization to integrate commissioning data, minimizing testing scope while ensuring GMP compliance.

Our expertise include conducting thermal temperature mapping studies to verify uniform temperature distribution in controlled environments like freezers (e.g., -80, Liquid Nitrogen, and controlled rated freezers), autoclaves, incubators, stability chambers, storage rooms and warehouses, identifying hotspots and ensuring compliance with GMP requirements. Included in our services are the following:

• Protocol development, sensor calibration, execution of mapping studies (loaded/unloaded, door-open scenarios), and data analysis with statistical reporting.
• Risk-based assessments to define acceptance criteria and worst-case scenarios.
• Integration with requalification programs for ongoing monitoring.

Interested in renting high-precision Kaye Validator or Ellab monitoring devices?

Contact us for details on equipment availability, short- or long-term rental options, and how we can support your next validation project.

We deliver cleaning validation services to confirm your cleaning processes effectively remove residues from all your process contacting equipment, preventing cross-contamination in GMP environments. Services we provide include:

• Authoring cleaning validation protocols, including cycle development, worst-case testing, development of swab/rinse sampling plans and acceptance limits, and analytical method selection.
• Execution support for CIP/SIP cycles, visual inspection and residue analysis, and validation report generation.
• Risk-based grouping of products/equipment to optimize validation efforts.

CERTUS specializes in QC laboratory commissioning and validation, ensuring labs are commissioned for accurate testing and compliant operations, this includes equipment qualification and establishing proper environmental controls. Services we provide include:

• Developed conceptual design layouts for GxP-compliant Quality Control laboratories, including Analytical, Microbiology, Environmental Monitoring, and Stability suites. Services encompassed optimized lab and equipment layouts, as well as the creation of comprehensive equipment lists tailored to each QC functional area.
• Commissioning/Qualification of QC lab equipment (e.g., analyzers, plate readers, osmometers) and utilities, with IQ/OQ/PQ protocols.
• Environmental monitoring setup, cleanroom classification, and integration with overall GMP programs.
• Gap assessments and remediation for startup labs.

We have extensive experience conducting relative cleanability coupon studies to evaluate material cleanability and support the selection of optimal surfaces for GMP processes and equipment. Studies have involved the evaluation of multiple surfaces – including stainless steel, EPDM, LLDPE, and PTFE – using representative process soils to determine cleaning efficacy. Services we provide include:

• Protocol development and report generation for coupon studies, including soil application, cleaning cycles, and residue analysis (visual, swab, rinse).
• Comparative assessments of materials like stainless steel, polymers, and coatings.
• Integration with cleaning validation for facility design.

Our team is well versed in facilitating risk assessments to identify, prioritize, and mitigate quality risks per ICH Q9. We rely on practical tools such as FMEAs and PHAs, ensuring they feed straight into your validation strategy. In practice, we have generated assessments for material disinfections, equipment assessments with system impact and/or criticality impact, using these insights to rationalize controls and streamline processes for GMP efficiency. Services we provide include:

• Leading team discussions for FMEA, PHA, and quantitative risk assessments
• Authoring risk management documents and traceability matrices.
• Ongoing reviews tied to changes and requalification.

We have conducted supplier assessments and GMP compliance audits to verify that vendors meet quality standards. Our experience include overseeing vendor qualification for key categories such as process gases (CO2, N2, O2, CDA), autoclaves and various analytical systems to ensure robust supply chains for our client facilities and manufacturing operations. Services we provide include:

• Vendor qualification audits (e.g., on-site audits as required), including documentation reviews and risk-based scoring.
• GMP compliance assessments for suppliers of equipment, utilities, and services.
• Remediation plans and follow-up audits.

Our team excels at conducting gap analyses to identify compliance deficiencies and providing remediation strategies involving regulatory alignment, risk-based corrective actions and detailed implementation plans. Services we provide include:

• Comprehensive gap assessments against GMP, ICH, and ASTM standards.
• Development of remediation roadmaps, including protocol revisions and training.
• Execution support for closing gaps (e.g., updates to requirement specifications and standardized procedures to achieve compliance).

We have extensive experience supporting environmental monitoring for cleanrooms and QC Labs during new facility commissioning and startup phases. This includes the development and execution of structured sample plans to track viable/non-viable particulates and microbes in controlled areas. Services we provide include:

• Development of monitoring programs with sampling protocols, limits, and data analysis.
• Execution of viable/non-viable sampling and recovery testing.
• Integration with cleanroom qualification.

Our team has authored disinfectant efficacy protocols to support validation of material disinfection and transfer processes across various GMP environments. This includes both full-scale facility applications and smaller-scale studies designed to quantify log reduction of diverse microbial populations on test surfaces following controlled exposure to disinfectants over specified contact times. Services we provide include:

• Protocol authoring for disinfectant qualification, including risk-based selection through the assessment of worst-case surfaces and contact times.
• Execution of in-vitro/in-situ studies with microbial challenge testing.

We recognize the critical importance of maintaining GMP integrity throughout all operations. Our team has experience initiating, managing, and closing deviations, change control records and CAPAs, ensure thorough investigations, effective implementation of corrective and preventive actions, and timely resolution in full compliance with regulatory expectations. Services we provide include:

• Facilitating investigations for deviations/CAPAs
• Authoring and revising SOPs for any necessary remediations as a result of deviations/change control records and CAPAs.
• Change control impact assessments and implementation.
• Tracking and closure with regulatory reporting.

Our team has experience developing and validating analytical methods to support Quality Control testing in GMP environments. We tailor these methods specifically for QC release testing, in-process controls and stability studies, ensuring full compliance with applicable regulations and guidelines. Services we provide include:

• Method development for assays like bioburden, endotoxin, and potency.
• Method Validation protocols per GMP, including specificity, accuracy, and robustness.
• Integration of methods with lab qualification.