Understanding the needs, requirements, and how to implement a quality system can be a daunting task. Organizations waste a great deal of time and money in trying to understand what they need to do and how to do it. This time and money can be better spent in improving the business and providing products or services in a more efficient way. In order to eliminate the time and expense of trial and error we can help you by providing a comprehensive approach that provides you with the knowledge and skills needed to effectively develop and maintain a robust and compliant Quality System.
Your quality system is not about creating a documentation system to show compliance, but rather it should have a long-term value for your business. The QS must be rational, practical, efficient, and compliant. It also has to define, describe, and control all business processes (including quality, technical, and regulatory processes). Furthermore, Quality Compliance will ensure that your staff have the skills and knowledge needed to take ownership of the process and have the ability to maintain and improve it into the future, by transferring the knowledge and skills necessary to achieve certification and continual improvement philosophy.
We offer uniquely customized consulting solutions that fits and addresses your business needs, not cookie-cutter solutions. Our expertise brings the deep insights and practical experience needed to help you address the most pressing issues. From drug product idea generation to regulatory submission and pre-audit preparation – we help you walk the path from ambition to achievement. You can trust us to eliminate confusion and non-value added activities by helping you focus on only what is required for certification and regulatory compliance. Quality Compliance Services (QCS) has:
- Helped over 27 companies achieve FDA or ISO compliance
- Submitted over 13 ANDA/NDA/BLA applications
- Implemented over 18 complete quality systems
Our methodology is to specifically design the system components in a way that fits your organization’s specific needs, and will include the following:
- Gap Analysis
- Executive Briefing (for your senior staff)
- Development of an Action Plan & Project Schedule
- Registrar Selection & Negotiation for Cost Reduction
- Awareness Training (for the general staff)
- Development of the exclusive QS Map
- Development of Management Policies
- Processes Mapping, which will include Development of Support and Core Processes
- Value Stream Mapping
- Smart Document Numbering System & Document Control
- Internal Auditor Program and Training
- 5S Training and Implementation (if needed)
- QS Implementation Review & Management Review
- Pre-Audit Support
- Registration Audit Support
- Integrating your quality system with the requirements of other ISO Standards or Global regulatory requirements.
