Audit and Assessment Scope
Our combined audit and assessment experience spans:
- Clinical research
- Laboratories
- Pharmacovigilance
- Computerized systems
- Vendors
- Quality management systems
Let's Talk about your quality needs
- bd@aderuspartners.com
- ADERUS Partners
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Our Expertise
GxP Knowledge and Technical Expertise
Our Expertise
GxP Knowledge and Technical Expertise
ADERUS brings together experience across GxP disciplines, regulated systems, and specialist quality domains. Our experienced team brings the relevant knowledge and technical background to each engagement.
Advancing GxP.Beyond Compliance.
Areas of Expertise
GxP Disciplines, Systems and Specialist Domains
GxP DisciplineGCP
GCP — Good Clinical Practice
Clinical quality expertise spanning Phase I–IV trials and patient PK/PD studies, alongside BA/BE research, with an understanding of investigator, sponsor, and CRO responsibilities.
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GxP DisciplineGLP
GLP — Good Laboratory Practice
Quality expertise in nonclinical research, including preclinical and in-vitro study environments, study records, laboratory systems, and the evidence supporting reported results.
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GxP DisciplineGCLP
GCLP — Good Clinical Laboratory Practice
Clinical and bioanalytical laboratory quality, including method-validation documentation, sample traceability, raw data, and reliable reporting of results supporting clinical research.
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GxP DisciplineGVP
GVP — Good Pharmacovigilance Practices
Pharmacovigilance quality systems, safety-data controls, service-provider oversight, and the quality responsibilities associated with outsourced safety activities.
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GxP DisciplineGMP
GMP — Good Manufacturing Practice
Manufacturing quality systems, documentation, and compliance requirements across relevant production and supporting activities.
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GxP DisciplineGDP
GDP — Good Distribution Practice
Quality requirements for storage, distribution, and clinical trial supply depot activities, including product traceability and supply-chain oversight.
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Laboratory FrameworksNABL · CAP
NABL and CAP Laboratory Quality Frameworks
Laboratory quality and competence in the context of ISO/IEC 17025, ISO 15189, and relevant NABL and CAP accreditation requirements, according to the laboratory's activities.
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Computerized SystemsCSV · GAMP 5
CSV and GAMP 5
Computerized system validation and lifecycle quality, including intended use, validation evidence, and the application of risk-based GAMP 5 principles.
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Electronic RecordsPart 11
21 CFR Part 11
Electronic records and electronic signatures in regulated activities, including the quality controls and supporting evidence relevant to applicable Part 11 requirements.
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Computerized SystemsAnnex 11
EU GMP Annex 11
Computerized systems used in GMP activities, with attention to lifecycle governance, validation, data controls, and responsibilities under applicable Annex 11 requirements.
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Medical DevicesSaMD
Medical Devices and SaMD
Specifically scoped quality and compliance expertise for medical devices and Software as a Medical Device, matched to the product's intended use and relevant technical requirements.
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TechnologyHealth Tech
IT and Health Tech
Quality expertise at the interface between technology development and regulated use, including user requirements, development quality, and validation strategy for GxP solutions.
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GDPR · HIPAA · CCPA/CPRAPrivacy
Data Privacy and Protection
Personal and health-data protection considerations under the EU General Data Protection Regulation (GDPR), US HIPAA Privacy and Security Rules, and the California Consumer Privacy Act (CCPA), as amended by the California Privacy Rights Act (CPRA). Expertise includes data-handling responsibilities, confidentiality, access, and information-sharing controls where applicable to the organization and its activities.
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Data GovernanceData Integrity
Data Integrity and Data Governance
Data reliability and traceability across collection, processing, transfer, reporting, and archiving, supported by clear ownership and appropriate electronic-record controls.
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CDASH · SDTM · ADaMCDISC
Clinical Data and CDISC Standards
Quality understanding across clinical data management and biostatistics, including study-data traceability and CDISC-aligned workflows involving CDASH, SDTM, and ADaM.
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DocumentationGDocP · TMF
Good Documentation Practice and TMF Frameworks
Documentation quality and consistency across study and quality records, including paper TMFs, eTMFs, Veeva Vault eTMF, and the DIA TMF Reference Model.
Discuss Your RequirementsRelevant Systems Experience
- EDC/eCRF
- CTMS
- IRT/RTSM
- ePRO/eCOA
- CDMS
- eQMS
- DMS
- LIMS
- LMS
- Safety databases
- Electronic archives
Each framework is considered within its applicable scope; the requirements depend on the activity, system, intended use, and jurisdiction.
International Experience
Inspection Experience and Global Audit Exposure
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Research Experience
Research experience spans:
- Phase I–IV trials
- BA/BE
- PK/PD studies
Therapeutic Exposure
Therapeutic exposure includes:
- Oncology
- Cardiovascular conditions
- Psychiatry
- Respiratory and infectious diseases
- Endocrinology
- Dermatology
- Ophthalmology
- Gastroenterology
- Orthopaedics
- NSAID studies
