Welcome To The Realtime Group

We offer a practical approach to other medical device and manufacturing companies through our collaborative consulting services to make the transition to process-based QSR compliance less abrupt and more culturally accepted. Companies that purchase a set of templates requiring significant customization are typically not as successful in the long run as Companies that create processes based on their existing knowledge, skills, and abilities. It is the 3D's that are important to create corporate wide compliance:

• Define (the processes to be compliant),
• Do (what you defined),
• Document (what you did).

Let us show you how to achieve the right balance starting with your existing operations. We understand 21 CFR Part 820, (especially cGMP, cGDP, and cGLP ) ISO 13485, and many other regulatory specifications. In fact we already use them in our own operations. We will help you gradually come into compliance with the applicable standards without stifling your ongoing development or production.

Whether product or process, the service begins with a thorough analysis of existing processes, records, and other documentation. From that, any gaps in compliance are identified, and alternative implementation plans are evaluated based on the knowledge, skills, and abilities of the current staff. In many cases, specific targeted Standard Operating Procedures (SOPs) can be created that refine processes already in practice. If installation of an entirely new process is necessary, our quality engineers work with your staff to convey the attributes of the required process, and then co-author the procedures, records & forms, and work instructions necessary to implement a compliant process. The service continues with assistance in organizing any existing documentation to show prior “intent” of conformance. Remember that writing documents for the sake of showing compliance is not sufficient if they can not be backed by a body of evidence supporting the actual practice.

The deliverables include creation or refinement of plans, procedures, forms, and instructions to address, as applicable:

• Overall Quality Plan
• Design Controls
• Corrective and Preventive Actions
• Document Controls and Records Management
• Purchasing Controls
• Identification and Traceability
• Production and Process Controls
• Labeling and Packaging Controls
• Subcontract / Supplier Management
• Post-Delivery Management

If you have received a Form-483 letter or you are preparing for an FDA inspection, let our network of Regulatory specialists assist in preparing your response. We can also arrange to be present during any inspection or audit --- typically more than half of the observations can be resolved before the visit is completed.