Quality Assurance

Pre-Audit Inspections/Mock Audit Inspections

The QA personnel at ClinTec are skilled and highly experienced at performing pre-audit inspections for clients involved in R&D, Clinical Trials, and Drug Manufacture. Our QA team understand the principles of working within a GCP, GMP and GLP environment and can provide expert guidance to clients who need to prepare for regulatory, client and ISO9000, ISO13485 inspections.

The audit service can be provided to:

• Clinical Sites – clinical studies (all phases)
• Pharmaceutical companies (all stages of life-cycle)
• Biotechnology companies (all stages of life-cycle)
• Medical Device companies (all stages of life-cycle)
• CRO’s and CMO’s
• Data Management houses
• Archiving facilities
• Cell banking facilities
• Testing laboratories

The QA Department can also perform vendor audits for clients who do not have the QA expertise in house and can provide coaching for junior members of staff who need to take on an audit responsibility within their company.

Deliverables include the execution of a full inspection and the compilation of a full report outlining findings and observations and areas that need to be actioned to ensure effective compliance.

Gap Analysis / FMEA Review

The QA Department is experienced in performing a “gap analysis” of all operational functions. The gap analysis is designed to identify areas where critical procedures may be “missing” or where areas could become non-compliant due to insufficient control. The QA team can also provide a full Failure, Mode, Effect and Analysis (FMEA) review of any manufacturing related process in order to determine areas of “risk” which can then be classified as critical, major or minor.

Deliverables include execution of a “gap analysis” or FMEA review and the compilation of a full report, classifying and ranking all components of the selected process.

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Corrective Action Plans (CAPA's)

The QA Department can provide a full follow up service to any pre-inspection/mock audit inspection. This includes the implementation and management of a CAPA plan that has been formulated from the audit observations. The QA specialists will guide the clients through the required action plan and provide expert advice on how to implement procedures to ensure effective closure to ensure compliance. This service can also be utilised by clients who have been cited with a number of major or critical observations from a regulatory authority inspection.

Deliverables include a formulated corrective and preventative action plan with details of how to address and close-out observations. The QA team will also be able to provide effective “hands-on” execution of any CAPA related tasks.

QA Manual, QA Document, SOP Writing

The QA Department has a wealth of experience in compiling complete quality systems, which include quality manuals, tailor made SOP’s and specific Working Instructions. The QA team can also provide a comprehensive review service of existing quality documentation systems and provide advice on how to set up a quality system that matches the individual business requirements. The QA team can also provide training and coaching to individuals who need to learn the skills of QA document writing.

Deliverables include the provision of a robust, traceable, controlled documentation system with final versions of the appropriate documents in a format that has been agreed with the client. The system will also include a comprehensive process flow chart that will detail the relationships between specific documents. Whether a single document or a whole system is required the quality of work delivered.

General QA Consultancy

Following on from audit findings, CAPA plans, and gap analysis reviews the QA team are able to provide general QA consultancy in a number of areas to support the remedial processes.
These include, but are not restricted to:

• Validation Consultancy
• Process Efficiency
• Process Optimisation
• Preparing for Regulatory Audits

Deliverables include a full assessment of the selected area and compilation of a full report, protocols, manuals and guidance documents where applicable.