compliance auditing
ARD Scientific LLC offers GLP/GCP/cGMP/21 CFR Part 11 Compliance Auditing and Gap Analysis services to the clients who need to evaluate internal, supplier or service provider facilities, processes, quality systems and procedures for regulatory compliance or project/contract requirements.
We also have expertise in auditing of GLP/GCP/cGMP required protocols, documents, records, data, and reports, as well as, auditing and assessment of computer systems and validation documentation for 21 CFR Part 11 compliance.
Ordinarily, ARD Scientific LLC consultants utilize proprietary Compliance Auditing and Reporting SOP and a set of standard audit tools and templates. At the client's request, however, our consultants will be trained and will use the client's internal procedures and templates.
Facilities, Processes, and Procedures
- Manufacturing & QC: Rx, OTC, Nutritional Supplements and Personal Care, including man-in-plant
- Nonclinical: Animal research, sample preparation & testing (including in-life inspections), archives
- Clinical: CROs and SMO, investigator sites (including Phase 1 and Phase 1 first-in-man), bioanalytical sample testing, and IRB
- Computer systems: Quality, document, project, drug, safety, and data management (including electronic and/or remote data acquisition) software developers and service providers
- Off-site
records & data storage
- On-site and Off-site data centers
Protocols, Records, Data, and Reports
Good Manufacturing Practices (cGMP)
- Clinical and quality agreements
- Controlled documents (policies, SOPs, tools and templates)
- Paper
and electronic master and
productions batch records, testing
specification and laboratory records - QA release records
- OOS investigations and CAPA
FDA Good Laboratory Practices (GLPs)
- Technical and quality agreements
- Controlled documents (policies, SOPs, tools and templates)
- Study protocols
- Paper and electronic study data
- Paper and electronic laboratory records
- Listings and tables
- Study and contributor reports
DA/ICH Good Clinical Practices (GCPs)
-
Transfer of Obligations, technical and
quality agreements
-
Controlled documents (policies, SOPs, tools and templates)
- Study
protocol
-
Informed consent
- Paper
and electronic study data
-
Safety and monitoring records
- Paper
and electronic laboratory records
-
Listings and tables
- Clinical study report
21 CFR Part 11 & Computer System Validation
- Configuration records
- Validation records (Validation/IQ/OQ/PQ)
- Change Control records