Independent GCP audits provide an insight into the quality of your clinical research at a point in time. They facilitate the monitoring of how well your quality management system is working and whether your SOPs are adequate and meet regulatory authority expectations.
QSI is able to provide a totally independent GCP audit of each of your trial programs. Since we are not a clinical research organization (CRO), QSI is able to evaluate your clinical trials objectively, without any conflicts of interest – an advantage that helps many companies and institutions identify issues early on.
Our GCP auditing services include:
- Project Management
- Clinical Monitoring
- IRB / EC Communication
- TMF Organization & Management
- Site Investigators
- Investigators Selection
- Records Management Archives
- Regulatory Documentation
- Regulatory Submissions
- AE / SAE Reporting
- Disaster Recovery
- IT Infrastructure
- SOPs Management
- Medical Devices Studies
- Data Collection, Source Documentation
- Any other related Service Provider
Good Manufacturing Practice (GMP) is the Quality Assurance that ensures products are consistently produced and controlled to the quality standards appropriate for their intended use, conform to the regulatory requirements stipulated by health authorities and compliant with the FDA’s guidelines under 21 CFR part 11. QSI Team will assist you to make sure all processes are compliant by conducting an independent GMP audit.
Whether your issue is with sanitation, labeling, validation, Standard Operating Procedures (SOPs), training, manufacturing records, aseptic processing, product adulteration, raw materials storage, risk management, or other quality issues, our GMP auditing services will provide the regulatory and manufacturing expertise required to help you prevail.
Our GMP auditing services include:
- Facilities Overview
- Facilities mapping
- Regulatory Submissions,
- SOPs Management
- Equipment Validation & Calibration
- Materials Management
- Environmental Conditions
- Production System
- Any other needed service
Good Laboratory Practices (GLP) is required for programs and studies submitted in support of product approvals, new products as well as pharmaceuticals, animal drugs and medical devices for FDA, the EU and any other applicable regulatory agency.
Based on the needs of the client, QSI will visit the laboratory facility and meet with the technical, management and quality assurance personnel to review existing GLP documentation and the current compliance with the GLP requirements
Our GLP auditing services include:
- Laboratory Overview
- SOPs Management
- Documents Overview
- Equipment Validation & Calibration
- Methods Validation
Pharmacovigilance audit activities should verify, by examination and evaluation of objective evidence, the appropriateness and effectiveness of the implementation and operation of a Pharmacovigilance system, including its quality system for Pharmacovigilance activities.
QSI Team is ready to assist you in any QA Activity related to the Pharmacovigilance as stated below:
- Pharmacovigilance Processes
- Interaction with other units / stakeholders
- IT System / Databases
- Reporting system
- SOPs Management
- Pre and Post Marketing Pharmacovigilance Audits
- Ongoing Risk Management Procedures
- Qualification & Staff Training
- Reference Safety Information
- Periodic Safety Update Reports (PSURs)
- Case Safety Reports (CSRs)
- Master Files
The system of physical devices, software, and IT services you use to conduct your regulated business is complex. That’s why there is an increasing need to ensure that all your systems are secure, recoverable, validated, properly maintained, and that any electronic signatures they produce are genuine.
QSI can conduct audits of the software, infrastructure, and IT services your company relies on, whether on your premises or off-site at a vendor facility. Your audit can be comprehensive, or focus on a particular functional area, business operation, or computer system. We verify compliance with 21 CFR Part 11 and other FDA regulations and guidelines.
Our Computer Systems Audits include the below services:
- 21 CFR Part 11 Compliance
- Validation Master Plan
- SOPs Management
- Spreadsheets and macros
- Design/Configuration
- Test plans, scripts, protocols, and reports
- Traceability and Audit Trials
- Software and documentation change control
- Archiving and data retention
- User documentation and support
- Configuration management
- Installation and maintenance
- Physical and electronic security
- Backup and recovery
- Facilities management
QSI supports customers through in providing a full range of regulatory activities.
Our service begins with the development of the regulatory strategy and concludes with the editing, amendment and submission of the necessary documents of the dossier. Due to the expertise of our consultants, fully electronic submissions for the EU, along with paper submissions are handled in the fastest and most professional manner, while ensuring that dossiers are compliant to the strictest regulations.
