GCP Auditing Services

As defined in ICH 5.19.1, the purpose of a clinical audit is to evaluate trial conduct and compliance in line with the protocol, SOPs, GCP and applicable regulatory requirements.

IT'sQA provides experienced and truly independent GCP auditing services of clinical studies in any phase, from I to IV and post marketing. Audits are conducted to standard operating procedures to assure compliance with ICH/GCP internationally.

Working with key personnel in your company, we can assist in the preparation of a complete audit program for a specific clinical trial or clinical development program; or we can execute individual audit tasks:

  • Investigator sites
    • Review of essential study documentation to assure compliance with ICH/GCP, all applicable regulations and SOPs
    • On-site and in-house documentation
    • Review of study conduct at site, storage and accountability of the IP, the data collected and the monitoring activities to assess data integrity, availability of source records and compliance with the protocol and GCP
    • Single or multiple investigator sites/paper or electronic CRFs
  • Trial Master Files
    • Review of essential documents in line with ICH/GCP, all applicable regulation and SOPs
    • Review in accordance with client SOPs
  • Phase I
    • Pre-qualification audits
    • Site/Study Audit
    • Paper andelectronic data capture systems
  • Suppliers
    • CROs, off-site archiving facilities, suppliers of computer systems
    • Independent audits to establish organisational ability of supplier to provide quality service in line with contractual requirements, ICH/GCP , applicable regulation and SOPs
    • Pre-selection, pre-study and live audits
  • Clinical Laboratories
    • Independent audits to establish organisational ability of laboratory to provide quality service in line with contractual requirements, ICH/GCP & cGLP, all applicable regulation and SOPs
    • Pre-selection, pre-study and live audits
    • Local and central laboratories
  • Database/Data Management
    • Review of data handling process/systems
    • Assessment of Data Management System
    • Data verification (can be executed using IT’sQA or client SOPs)
  • Clinical Report
    • Assessment of compliance with ICH E3 and E9
    • Data verification against source data
  • Documentation
    • Protocols
    • CRFs
    • Investigator Brochures
    • Patient Information Leaflets
    • Regulatory submissions
    • Assessment of compliance with GCP as relevant
    • Data verification against source data
    • Internal consistence and meaning
  • Pre-Regulatory Inspection Audits/Gap Analysis
    • Review your processes, quality system, policies, practices and SOPs for compliance with the sponsor's responsibilities for GCP
    • Report with observations and suggested corrective and preventive actions
    • Help with implementation of actions to prepare your company for a regulatory inspection
  • Computer System Audits
    • Review computer systems used in clinical research for compliance with FDA guidance and requirements to ensure they are validated to GCP

GLP Auditing Services

IT’sQA offers a comprehensive range of GLP and GCLP audit services which can be undertaken internationally. These involve the following:

  • Clinical Laboratory Audits
    • Independent audits in line with GLP, all applicable regulation and SOPs
    • Pre-selection, pre-study and live audits
  • Contract/Suppliers Audits
    • Evaluation of organisational ability for providing quality services in compliance with GLP
    • Pre-selection, pre-study and live audits
  • Pre-Regulatory Inspection Audits/Gap Analysis
    • Review of processes, quality system, policies, practices and SOPs for compliance with the sponsor's responsibilities for GLP
    • Report with observations and suggested corrective and preventive actions
    • Help with implementation to prepare your company for a regulatory inspection
  • Computer System Audits
    • Review computer systems used in pre-clinical research for compliance with FDA guidance and GLP requirements
  • GLP Certification
    • Obtaining GLP certification

GMP Auditing Services

European Directive 2001/20/EC has had a significant effect upon companies’ audit and quality obligations, since it requires that GMP requirements be applied to investigational medicines as well as marketed products.

IT’sQA offers a comprehensive range of international cGMP audit services to ensure that your facility, suppliers and products meet all applicable regulatory requirements. These involve the following:

  • Pre-Regulatory Inspection Audits/Gap Analysis
    • Independent audits in line with GMP, all applicable regulations and client SOPs
    • Reporting with observations and suggested corrective and preventive actions
    • Preparing for regulatory inspections
  • cGMP Audit Programs
    • Developing detailed audit programs for a specific product/system
    • Undertaking audit programmes independently or in collaboration
  • Contract Manufacturer Audits
    • Independently evaluating the organisational ability of contract manufacturers
  • Contract Laboratory Audits
    • Reviewing/monitoring cGMP compliance from pre-selection to study execution
    • Covering all testing activities associated with the manufacture of Investigational Products for human use
  • Suppliers/Vendors Audits
    • Undertaking inspection audits with each supplier/vendor of critical raw materials, components and supplies to assure compliance with cGMP
  • Quality/Product Audits
    • Conducting in-depth Quality/Product Audits to assess the completeness of the company’s quality system and audit trails
    • Reviewing IP critical items affecting product quality and product release
  • Computer System Audits
    • reviewing computer systems used in manufacturing for compliance with cGMP and FDA guidance and requirements

Pharmacovigilance Audits

There is now increasingly complex safety legislation and standards designed to monitor risk through the clinical trial and post-marketing phases of the life cycle of new medicinal products. IT’sQA can offer a comprehensive range of audits of pharmacovigilance systems and processes:

  • Pharmacovigilance Audits
    • Independent audits in line with all applicable regulations and SOPs
    • Systems and data audits
  • Contract/Suppliers Audits
    • Evaluation of organisational ability of suppliers for providing quality services in compliance with the regulatory requirements for pharmacovigilance
    • Pre-selection, systems and data audits
  • Pre-Regulatory Inspection Audits/Gap Analysis
    • Reviewing your processes, quality system, policies, practices and SOPs for compliance with the sponsor's responsibilities for pharmacovigilance
    • Report with observations and suggested corrective and preventive actions
    • Help with implementation to prepare your company for a regulatory inspection
  • Computer System Audits
    • Reviewing computer systems for compliance with FDA guidance and requirements to ensure they are validated to Good Pharmacovigilance Practice standards

Inspection Readiness and Support for Regulatory Inspections

We can review your systems and processes to ensure your organisation is inspection ready at all times, help you to set-up these systems, review your files, conduct a ‘mock’ inspection, raise awareness amongst staff, and help you prepare to host inspections by regulatory bodies.

IT’sQA can offer a mock inspection service across the GxP range and in Pharmacovigilance. This may involve:

  • Undertaking a gap analysis
  • Providing a comprehensive report/action plan
  • Assisting with the implementation of the action points
  • Providing targeted training programmes
  • Providing interview practice to staff
  • Organise and host the inspections as QA representatives of your company
  • Extending the service to relevant sites or third party providers

Quality Management Consultancy

An effective Quality Management System (QMS) is fundamental for complying with GCP, GLP and GMP and for validating computer systems during their SDLC.

ISO 9001:2008 is currently the best internationally recognised standard for QMS and we have adopted this for our company.

IT’sQA auditors are experts in the drug development process and with the development of computer systems used in this regulatory environment. They have the necessary skills to ensure your ISO internal audit is as valuable as possible.

Our auditors are on the knowledge forefront of the changes to ISO standards as well as GCP, GLP and cGMP. They can help you both improve processes and meet all regulatory requirements while ensuring compliance with ISO standards.

  • ISO QMS
    • A unique set of documents and templates designed to meet ISO as well as GCP, GLP and cGMP requirements
    • Provided with the necessary support and training for adapting and integrating them into your organisation
  • ISO Internal Audits Plan
    • Working in collaboration with the relevant management in your organisation, our ISO and GxP experts can assist in the preparation of an internal audit plan to monitor compliance with ISO and relevant GxP throughout the year
  • ISO Internal Audits
    • Conducting internal audits for assessing compliance with ISO/relevant GxP
    • Providing reports on necessary actions
    • Implementing these in partnership with the client
  • Suppliers/Vendors Audits
    • Conducting audits of suppliers/vendors to assess compliance to ISO standards
    • Developing a vendor audit program and participating with your personnel on audits
  • Pre-ISO Certification Inspection Audits
    • Working with quality and regulatory specialists in your organisation to analyse your practices, documents and records for compliance with ISO
    • Providing observations and suggestions to better prepare your organisation prior to a certification/registration audit or a surveillance audit by a certification agency
    • Supporting the implementation of these recommendations

Computerised System Validation

When data is handled electronically it is important to ensure that the computer systems used are suitably validated and comply with the requirements of 21 CFR part 11. At the same time, computer systems must be designed and used in such a way that the applicable GxP predicate rules (GCP, GLP or GMP), relevant regulatory requirements and SOPs are met at all times.

IT'sQA provides comprehensive assessment of computer systems used in clinical research. Assessments are often conducted in teams with the lead GXP Auditor accompanied by the specialist CSV auditor/consultant.

In addition to the above, IT'sQA has joined forces with Wanstor Ltd to provide auditing and IT technical skills in order to effectively assess the main areas of the IT environment that are most critical to the delivery of good IT service and business continuity. Our full service range is as follows:

  • Audits of Computer Systems

    Reviewing computer systems used in pre-clinical, clinical and manufacturing research to ensure they are validated to meet the relevant GxP requirements. We have pre-qualified and audited the following systems

    • Data management
    • Pharmacovigilance
    • Quality assurance
    • Remote Data Capture (RDC)
    • E-CRFs
    • Medical imaging systems
    • Study portals
    • Project management systems
    • Interactive Voice Response Service (IVRS)
    • LIMS
    • Chromatography data systems
  • CSV Audits
    • Reviewing processes, quality system, policies, practices and SOPs for compliance with your responsibilities for computer systems used to generate data for marketing authorisation purposes, including 21 CFR 11 compliance
    • Reviewing corporate validation policies
    • Assisting implementation of corrective/preventive actions e.g. process simplification/redesign, laboratory automation strategies, equipment qualification
  • Data Centre/Facility Audits
    • Assessing your data centre and its suitability to host data securely and in compliance with GxP regulations and industry expectations
    • Includes facilities, procedures and practices
  • Supplier Audits
    • Evaluating contract suppliers for their organisational ability to offer you the quality service you expect
  • Documents Audits
    • QA review of validation documents (User Requirements/Functional Specifications - URS and FDS; validation/test plans and reports) against other documents, records and current regulations to ensure validation of the computer system

Training/SOP Development

IT’sQA can offer a full training service in GCP, GLP, GMP, CSV and pharmacovigilance. We can also deliver training packages on US and European clinical trial legislation. These services can be tailored to the specific needs or your organisation and delivered on-site at your premises.

IT’sQA can also develop and provide a comprehensive set of SOPs in relation to GCP, GLP, GMP, CSV and pharmacovigilance. These will be compliant with relevant legislation but can be tailored to ensure integration with any existing client SOPs.

Alternatively, IT’sQA can undertake substantive reviews of existing SOP procedures and assess these for compliance with the relevant standards. Where applicable, we can draw up and implement and action plan for correcting any gaps or weaknesses identified through this process.

IT’sQA can also provide an ongoing SOP support service for clients, ensuring that their systems and procedures keep up to date with any changes in the legislation.

Systems Audits

System audits and assessments are required to examine each and every facet of a quality system and its compliance with regulatory and process requirements. They also provide an opportunity for process improvement.

IT'sQA provides experienced and truly independent auditors and specialists to assess all systems and processes in clinical research. These are examples of system audits that we have worked on:

  • Pharmacovigilance
  • Clinical Monitoring
  • Selection and Management of CROs
  • Data Handling and Statistics
  • Management and distribution of Investigational Medicinal Products
  • Training
  • Records management and archiving
  • Documents management
  • Selection and management of investigational sites
  • Project management

ITsQED

An effective Quality Management System (QMS) is necessary in order to comply with GCP, GLP and GMP and for validating computer systems. An effective quality management system is also essential for your business.

In order to respond to the needs of our customers we have developed a unique service called IT’sQED.

It is more than just hiring a QA contractor, it is your independent QA department perfectly integrated with your company for you, your clients and inspectors. For more information, go to IT’sQED