In today’s intense and increasingly competitive market, companies in every industry are constantly challenged. They need to deal with global suppliers, short operating margins, and strict regulations, in addition to managing both risks and the increasing pressure to accelerate time to market. Quality Management Systems (QMS) are critical to show compliance with the regulations and GxP requirements and show compliance during inspections. QMS is now an integrated part of activities for all Marketing Authorizations and not just limited to manufacturing activities. Many manufacturing facilities are struggling to gain regulatory approvals/certifications as well as achieving and sustaining market leadership.
At Apple Vision, we have an extensive team of quality experts to support your organization in setting up a quality management system (QMS) and providing you with ongoing support as a virtual quality team. Our Quality Management System (QMS) compliance consulting provides regulatory consulting services, in addition to implementation of Quality Management Systems for your organization. Our group ensures the appropriate licensing, labeling and legal compliance for your manufacturing organization. Our compliance consulting services group monitors the ever changing landscape of legislations issued to ensure legal compliance with regulatory agencies. We advise on and coordinate the approval and registration/certification of your manufacturing facility.
Apple Vision can assist your manufacturing organization in: –
- Planning, developing and implementing a quality management system compliant with various applicable standards and GxP requirements.
- Gap analysis reports highlighting the areas of improvement in existing quality systems against the current site activities and regulations.
- Updating of an existing quality management system based on gap analysis
- Providing guidance on all aspects of a quality management system including training, documentation and documentation control, change control, vigilance, GxP, among others.
- Creation/updating of specific processes to meet regulatory and quality system requirements
- Pre-inspection audits of regulatory and quality management systems to assist in preparation for an inspection and to assess readiness for certification/approval or accreditation.
- Pre-inspection training that include mock interviews to prepare staff for an audit environment and best conduct for inspections, and how to respond to inspection reports
- Pre- and post-inspection liaison with regulatory authority inspectors on behalf of client.
- Performing supplier audits on behalf of client companies
- Conducting due diligence technical reviews and consulting on a product file/dossier.