The foundation of any successful organization is a system that ensures consistency, quality and repeatability. Reglera understands that all businesses are unique. Whether you are a newly emerging company or an existing multinational corporation, Reglera can help you ensure your quality system fits your organizational structure.
We have systems and services to cover all elements of QS Regulation contained in the Code of Federal Regulations and to enable you to get your ISO certification. These regulations cover elements of quality system regulation from initial product design to product distribution including management and organization, design, equipment, purchase and handling of supplies, production and process controls, packaging and labeling control, distribution, installation, complaint handling, servicing, and records.
Some of the quality system support services we provide include:
Manufacturing Quality Assurance
Reglera’s team of professionals brings many years of successful strategy development to the table. We work with each client individually to understand their products, markets and regulatory risk tolerance. From there, we develop an overall quality system strategy to expedite product approval while putting in place the necessary systems to meet the regulatory requirements and improve overall operational efficiency.
Our approaches and systems are based on best practices and have been implemented in many different types of organizations with great success. Our clients are able to focus on their business activities while knowing they are taking the most efficient approach to regulatory and quality assurance.
Market Surveillance
Cellular Tissue Organizations and Device companies must set up a system that appropriately monitors product activity in the field that could lead to findings of poor product quality.
These types of communication could include:
The requirements of handling these types of communications are often misunderstood and frequently cause difficulty with those companies trying to comply. Each of these instances need to be handled efficiently, without any inconvenience to your end user and appropriate action should be taken up to and including a product recall.
Reglera can help set up a system to comply with the applicable regulations for market surveillance or manage it through our outsourced complaint handling service. This system will ensure that a procedure is set up to ensure the appropriate regulatory filings (such as HCTP Deviations, MDR Filings and Adverse Reaction Reports) take place in the proper time frames and that appropriate action is taken based on the complaint up to and including a product recall. We also can perform audits of this system, feed the results to CAPA or provide trending and reporting to management.
Basic Quality System Elements
There are certain aspects of any quality system that simply cannot be outsourced or assigned to another party but must be managed internally. Examples of these systems include Corrective and Preventive Action (CAPA), Management Review and maintenance of a Quality Manual.
Reglera works with each client to ensure these systems are set up properly. Our experience in implementing these systems ensures they are appropriate in scope to the size of the organization and the product(s) being manufactured. We provide comprehensive training and audit the systems to maintain consistency and assurance that our clients have a solid quality system foundation for which they are ultimately responsible.
Design Control – (For Medical Device Manufacturers)
Almost without exception, Medical Device companies struggle to successfully implement design control systems that are compliant and efficient. Reglera has extensive experience developing, right-sizing, implementing design control programs that not only meet regulatory requirements, but are simple to understand and execute. Whether you need a turn key solution or simply want to improve the efficiency of your design control program without compromising your level of compliance, Reglera has a solution to fit your needs. Find out why companies of all sizes have turned to Reglera to implement or improve their design control programs.
Reglera's Design control program covers all required aspects of 21 CFR 820 and ISO 13485:2003 including:
Validation
If your organization needs any type of validation or verification, rely on our expert staff that performs these types of activities on a daily basis. When you need objective evidence that your processes, equipment, software or product designs produce consistent results, our team can help you design the appropriate validation protocol and execute the validation according to those protocol. If a particular validation fails, we can help you analyze the risk and re-execute according to newly approved protocol.
Some of the validations we provide to clients include: