Our services are the principal part of our business. They comprise Thermal Validation, Commissioning, Qualification and Validation, Clean Room Validation, Computer System Validation and Data Integrity, and Bio-Decontamination.
Together, they address the validation, qualification, engineering and regulatory compliance requirements that arise across the lifecycle of manufacturing facilities, utilities, equipment and computerised systems, including their establishment, commissioning, qualification, operation, maintenance, modification and periodic requalification.
Thermal Validation
Wired and wireless thermal validation, temperature mapping and steam quality testing for critical equipment, storage areas and processes.
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Commissioning, Qualification & Validation
Science- and risk-based CQV of facilities, utilities, equipment and systems, from design qualification to performance qualification.
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Clean Room Validation
Cleanroom validation as per ISO 14644-1, 360 degree smoke studies, and compressed air and nitrogen gas testing.
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Computer System Validation & Data Integrity
GAMP 5 computer system validation, compliance assessment and regulatory support, audit support and remediation.
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Bio-Decontamination
Hydrogen peroxide fogging to destroy pathogenic and other microorganisms across cleanrooms and aseptic enclosures.
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Compliance and validation is a specialised discipline that supports manufacturers of pharmaceuticals, biotech products, medical devices and food, and increasingly semiconductors, defence equipment, electric vehicles and renewable energy components, as they design, build, qualify, validate and operate their manufacturing facilities and computerised systems.
Our services and products help these manufacturers demonstrate to regulators that their facilities, equipment, utilities and computerised systems consistently perform as intended and comply with applicable Good Manufacturing Practice, Good Automated Manufacturing Practice and related quality frameworks.
Requirements vary with the regulatory and quality framework, the stage of the facility, equipment or system lifecycle, and the customer's operational and compliance needs. They can arise at the time of:
Depending on the engagement, customers may need compliance and validation services, specialised instrumentation for testing, monitoring, qualification and verification, data logging solutions, or a combination of these.
Instruments from global OEMs
Specialised instrumentation we supply as an authorised channel partner, and use in our own validation and qualification engagements where required.
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Data loggers made by GAMP
Data loggers for temperature, humidity and other environmental parameters, with the FacilityOne monitoring platform.
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Reviewed by Quality Assurance
All validation activities are reviewed by our Quality Assurance team, under standard operating procedures that keep our work consistent with applicable quality standards.
Trained validation engineers
Our validation engineers are trained before they undertake any validation activity, and follow structured planning, quality protocols and GxP/ISO-aligned practices.
Calibrated instruments
All validation and monitoring instruments we use are calibrated in accordance with applicable national and international standards.
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