Quality & Compliance Services
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Quality and compliance serve as the foundation of the pharmaceutical industry, where precision and dependability are of paramount importance. Within this highly regulated sector, strict adherence to quality standards and compliance with regulatory mandates are not only obligatory but intrinsic to ensuring the safety and effectiveness of pharmaceutical products. Across the entire spectrum, from research and development to manufacturing and distribution, each phase necessitates meticulous attention to quality assurance practices.
For the past 25 years, Integrity has been at the forefront of this commitment, consistently focusing on delivering excellence in quality and compliance within the pharmaceutical industry.
Our life science experience coupled with an active participation in industry forums such as ISPE GAMP® and RQA provides a unique insight into regulatory expectations and industry practices.
Our patient centric approach ensures that we apply intelligent risk-based thinking to everything we do, focussing our efforts on those areas that have the greatest impact on patient safety, product quality and data integrity. Encouraging the adoption of automated processes to establish continuous control and oversight is fundamental to robust and effective quality and compliance.
Our Computerised System Validation consultants ensure that the validation effort is scaled based on process risk and solution complexity. Our hands-on approach means that we are actively engaged at each stage of the validation lifecycle in terms of planning, execution and review.
Our consultants ensure the validation approach is fully integrated with the project delivery approach, and will establish a clear and common understanding of expectations across all disciplines of the project team.
Applying the right approach is key to successful implementation, whether that is an agile, interactive, or sequential approach, we will ensure that the most appropriate deliverables are planned based on the project and solution characteristics.
Data integrity is the foundation of the Quality Management System, supported by risk-based technical controls that reduce the opportunity for data integrity incidents.
A data integrity culture must be established from the very top of the organisation, with open reporting of data integrity risks and incidents.
A multi-disciplined approach to data governance must be established, considering different perspectives of data, e.g. GxP, Data Privacy, Information Security and protection of intellectual property.
A flexible approach to evaluation of data integrity risk assessment, including maturity assessment of organisational, procedural, and technical controls, evaluation of historical data integrity incidents and GEMBA walks should be considered.
Improvement plans focussing on raising the maturity of data integrity controls will enable your organisation to improve overtime and in accordance with risk.
Let us manage your internal and external audit and assessment program by supporting the planning, execution, reporting and CAPA planning. Our audit team have extensive experience of internal process, project, system and vendor audits. Integrity’s global footprint means we can supply auditors from various locations to minimise the cost of travel. Applying a risk-based approach ensures an appropriate approach to assessment, whether that be remote assessment or on-site audits.
Expand your internal capability through Integrity’s Education & Training programs. We can deliver a range of business-to-business programs for those that require an introduction to the principles of quality and compliance to experienced practitioners. We can customise our programs to focus them on your operations and maturity to maximise the benefit.
SAP RISE platform migration
SAP upgrade and cloud migration
Risk-based validation
Managed Test Services
Service Transition
Data Integrity
ALM Operationalisation
MTS Implementation