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Pharmaceutical Process Assessments
Development & Training
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1. |
Review existing process (s). |
2. |
Determine scope of the process. |
3. |
Develop a Process Map or Maps. |
4. |
Develop necessary process tools (Matrix, etc.) |
5. |
Develop form/forms as required. |
6. |
Provide site-training packages. |
7. |
Provide complete on site training or Train The Trainer. |
8. |
Provide on going site support as needed. |
9. |
Audit processes to ensure on-going compliance. |
10. |
Provide complete validation support for both process as well as software. |
11. |
Facilitate the selection process for Software and the Software Supplier. |
Packaging & Labeling Process Improvements
Assist in the development of the following:
| 1. |
Review of existing packaging and labeling processes. |
2. |
Conduct a gap analysis as per FDA Guidance Documents. |
3. |
Develop process controls to ensure security and quality. |
4. |
Review all component specifications and make revisions as necessary. |
5. |
Establish component supplier quality selection criteria and certification process. |
6. |
Assist with selection of Pack Management and Supplier software. Writing FRS/SDS/Contract Documents. |
7. |
Provide supplier audit support. |
8. |
Develop Training programs and support training activities. |
9. |
Assist in the development of associated SOPs. |
10. |
Provide full process validation services. |
Manufacturing & Packaging Equipment
Assistance with the following:
| 1. |
Total Project Management. |
2. |
Design and Selection of equipment. (FRS/DS/Contracts) |
3. |
Systems Integration. |
4. |
SOP and Operations Manuals Development. |
5. |
Complete Validation Support |
6. |
Installation. |
7. |
Commissioning and Start up. |
8. |
Training. |
PROCESS CONSULTING
Process Management Is The Key To Regulatory Compliance.
Consistency is the key to quality control. Forward-thinking organizations are adapting their approach to regulatory compliance by adopting a holistic, top-down strategy that Process management and control is the key to compliance. Given the current pace of regulatory change, you need expert guidance to navigate and assess the impact of current regulations on your organization. RMV is your compliance partner. We offer a comprehensive range of services to assist you in establishing programs for sustained compliance. Our risk-based philosophy and expert methodologies in process analysis, development, and process improvement can assist you in meeting your compliance objectives in the most cost effective manner. RMV offers expert
services to help develop, improve or optimize regulated processes such as CAPA, change control, and others in a cost-effective manner. Our service includes comprehensive review of existing processes, thorough gap analysis, and practical recommendations and options for improved efficiency. Process automation is critical to helping your organization achieve sustained compliance. EnterPAS™ is the fastest growing software application designed exclusively for compliance process management in life partnership with EnterPAS, RMV offers an unparalleled combination of services and software products to help you design and automate your quality processes to ensure that your organization achieves and maintains compliance.
Contact: JIngram@esdrmv.com
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