An audit is a systematic and independent assessment of an organisation processes or conduction of a clinical trial. It is carried out to assess compliance with national and/or international regulatory requirements.
At Insight QA the audit services we provide can range from a one-off individual audit through to a global QA auditing schedule.
Typical audit approach:
Quality management system development / maintenance
A quality management system (QMS) is a set of policies, processes and procedures required for planning and execution (production/development/service) in the core business area of an organisation (i.e., areas that can impact the organisation’s ability to meet customer requirements).
An organisation’s quality management system should be simple, meaningful and consistent with relevant regulatory standards. It should also be able to grow with your organisation and meet any future requirements – regulatory or commercial – without unnecessary re-working.
At Insight QA we can help develop or improve your company systems by analysing the company current business and future scope using the following techniques:
- A Gap Analysis of current system: this is a in depth review of the company services/products, the current regulatory requirements and personnel interviews of current processes. The final report will identify the system gaps and what the company requires in terms of documentation in order to be compliant.
- Process Mapping: a worldwide visual tool used to simplify and easily identify quality system gaps.
- Risk Assessment of known and unknown risks to the business
Inspection Preparation/Support
Preparing for and managing a regulatory or compliance inspection can be very time-consuming. Good, effective preparation will have a significant impact on the outcome of the inspection, so it is important to take the time and help you need to get it right.
The insight QA Team helps clients manage the preparation process for compliance inspections (FDA, MHRA and ISO) across all sectors, including GCP, GMP and GLP.
We can provide support throughout the complete inspection process including preparation, hosting and follow-up, or simply assist with the preparation in any area you feel requires support. This can include conducting mock inspections and interview training.
In-house QA support
Managing an existing Quality System and planning/implementing a Quality Management System (QMS) within an organisation requires a significant investment of time and talent. This often places a strain on a company’s current employees especially in smaller companies with minimal resources.
At Insight QA our experienced professionals will provide QMS Support at your facility by joining and leading your teams when required. Whether your team requires Total Quality Management mentoring / coaching or hands-on support identifying / facilitating improvements, Insight QA can provide the professional support that meets your needs. Long or short-term support is available to help you succeed.
In house support services include:
- Development and implementation of Quality Management Systems (QMS)
- Standard Operating Procedures, Company Policies, Work Instructions, Manuals, Forms/Templates and business continuity plan development and ongoing yearly review.
- Resident and on-site representation for Quality Assurance activities, including:
- Management Review support
- Internal audits/ external audits /supplier audits
- CAPA management (corrective and preventive action)
- Change/Deviations Management
- Risk Assessment/ Risk Management
- Root Cause Analysis (RCA) to identify, understand, correct and prevent the recurrence of nonconformance/deviations
- Supplier Development, Process Improvements, Implementation of Best Practices
- Training Development and delivery of applicableindustry standards.
- Management and Development of training programs, training records and yearly reviews of current company staff