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Global Harmonization of Quality Systems after an Acquisition
INDUSTRY
PharmaceuticalsMedical Device
SERVICES
Quality AssuranceGxP Quality & Compliance
SKILLS
ValidationRisk Mitigation
Project Management
Quality Management System
Global harmonization of quality systems completed within 18 months.
The Challenge
A global medical device and pharmaceutical manufacturer had recently acquired another medical device company. As part of the acquisition, the client needed to harmonize all quality systems in order to ensure compliance. However, they had two separate quality systems — one for IT and one for products, while the acquired company only had one. With over a thousand combined applications that needed to be consolidated and simplified, the client was struggling to locate the resources with the IT compliance knowledge required to achieve compliance on a global scale. Due to the complexity of the project, tight timeline, lack of in-house experience, and previous successful partnership with Oxford Global Resources, the client selected us to assist with this multi-faceted initiative.
The Solution
Oxford made the connection to a Project Manager, SQA Lead, Senior SQA Consultant, Quality Assurance Analyst, and Document Change Control Specialist to assist with the consolidation of the GxP applications. With the right resources in place, the number of applications the company used to manage and support their existing quality systems could subsequently be reduced. Primary responsibilities included authoring, reviewing, auditing, and approving project documentation associated with the software development life cycle to support corporate, division, FDA, and other regulatory requirements. Specific tasks included:
- Define validation strategies, plans, and expected deliverables
- Lead Global Computerized System Validation (CSV) projects
- Coordinate implementation of validation activities for global systems, ensuring the requirements are met
- Review and approve validation deliverables
- Approve deviations and exceptions encountered during execution of validation protocols for global projects
- Prepare and provide validation summary reports addressing completed deliverables, and define any further actions when necessary
- Notify management and external counterparts of major findings, issues, and areas of risk, and action plans to manage them
- Implement procedures to ensure that products meet the quality required by customers, regulatory authorities, and EPD standards
- Monitor, approve, and advice (impact analysis) on changes to computerized systems
- Provide operational support to global computerized systems and the managing IT departments
The Result
Due to our expert team’s knowledge and extensive experience in quality assurance, IT supplier quality, training, CAPA, SLC, and document change control, the consolidation initiative was completed within 18 months — six months earlier than the expected 24-month timeline. The Oxford Project Manager was able to lead the project, and with combined efforts, achieve deliverables and milestones leading to the completion of the initiative ahead of schedule, much to the client’s satisfaction.