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 Life Science Quality is a business unit of PQE that offers the necessary support and assistance during all phases of the medical device life cycle, from R&D to production and distribution processes.
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QUALITY MANAGEMENT SYSTEM
- Quality policy definition
- Quality manual
- Quality plans
- Quality objectives and KPIs
- Process mapping and SOPs
- Documentation management process
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INTERNAL QUALITY AUDITS
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TRAINING
- Training plans
- In house courses
- E-learning
- Effectiveness check questionnaires
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RISK MANAGEMENT
- Risk assessment
- Risk analysis
- Risk monitoring programs
- Risk management SOP
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SUPPLIER QUALIFICATION
- GxP audit (third parties manufactures, OEM, distributors, investigational sites, CRO) - audit to IT suppliers (qualified auditors tick-it & PDA) - audit to raw materials, process equipment laboratory instrumets and utilities suppliers
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CAPA SYSTEM IMPLEMENTATION
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CUSTOMER SATISFACTION SURVEY
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PREPARATION OF INSPECTIONS (FDA/EU/Notified Body)
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COMPLIANCE PROGRAMS AND READINESS PROJECTS - Front office & back office shadow room organization - mock audits - respond post inspection - Remediation plans
- CE MARKING
- US 510(K)S
- US PMAs
- OTHER REGULATORY REQUIREMENTS : (Subscription in italian repertory)
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| collected over the years in dealing with international regulatory agencies, notified bodies and related inspections, PQE can provide added value for the implementation of integrated quality management system in the most cost-efficient and time-saving manner. |
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requires multidisciplinary expertise and process regulations; this complex know-how can be provided by our experts having a unique integrated know-how in engineering, information technology and quality into regulated environment.
Life science quality is recognized as market leader for regulatory bodies inspection support. |
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