Quality Assurance Consultancy supports regulated companies in achieving compliance with 21 CFR Part 11 Electronic Records and Electronic Signatures (ERES) requirements. Their specialists assess current compliance levels, perform gap analyses against Part 11 and applicable predicate rules, and evaluate existing systems. They also provide comprehensive computer system validation services, including SOP review, preparation of master and testing validation plans, execution of validation test scripts, auditing of test results, and staff training.

Quality Assurance Consultancy has implemented over 100 GLP programs for research, CROs, sponsor, university, and government laboratories. They support clients through gap analyses, QA unit setup, SOP development and harmonization, GLP training, documentation standardization, implementation support, and assistance during regulatory inspections.

Quality Assurance Consultancy delivers flexible GLP QAU support, serving as either an integrated or independent quality assurance unit. Services include audits, inspections, reporting, SOP and file maintenance, GLP training, and regulatory compliance support. They also offer outsourced QAU solutions for smaller or emerging organizations, with expertise spanning chemistry, toxicology, environmental, field, endocrine, antimicrobial,and entomology studies.

Quality Assurance Consultancy develops and updates GLP/QMS SOP programs for organizations worldwide. They create customized SOPs across all key areas, including administration, QAU, protocols, documentation, IT, laboratory procedures and equipment, test systems, study reports, archives, and validation.

Designing, writing, and evaluating protocolsPreparing study reports Fulfilling study monitor/sponsor responsibilities Conducting technical data and report reviews Identifying and qualifying contractors

Quality Assurance Consultancy provides independent GCP quality assurance for clinical studies, serving as third-party auditors for sponsors and CROs. Services include CRO and site qualification, clinical and data audits, IRB and investigator brochure reviews, trial master file reviews, and clinical report audits.

Quality Assurance Consultancy provides customizable GLP training seminars, offered on-site or remotely, with flexible formats and durations. Training supports FDA and EPA requirements and is tailored for study directors, QA staff, sponsors, and management.