Validation Studies

Validation Studies

When it comes to validation, it is always true that the whole is greater than the sum of the parts. When the proper relationships between validation and the other firm’s activities are established, there is a synergic effect of greater compliance and some tangible operating benefits. In other words, validation is not a standalone activity; it is one that relies on many of the pre-existing activities within a firm.

There are basic validation requirements expected by the FDA as well as foreign regulatory agencies:

Policies: policies should be written in a way that facilitates meeting global objectives, allows flexibility in implementation, and is useful over an extended period of time.

Protocols: these are the foundation for nearly all efforts.

Planning documents: these are project-oriented to help organize the validation tasks.

Summary documents: a concise and summarized validation study will be audit-friendly and provide regulators with what they are looking for during an audit.

Regulatory agencies such as the US FDA have long established validation as a core requirement of quality assurance for medical device manufacturers. Still, many companies fail to develop an adequate validation program, which can prove costly if discovered by an inspector. Over the last several years, inadequate validation has been one of the most common sources of US FDA 483 findings, so it is critical to address this requirement early. Responding to a Form 483 from the US FDA is disruptive and expensive, but can be much more so if major changes are required to retroactively validate a process, system, piece of equipment or working environment.

Synergy Bioscience is experienced in the validation of many types of equipment, processes and systems used in a wide variety of medical device applications.

Validation is broadly applied across the organization to ensure that products, equipment, processes, software and systems operate as designed and intended. Successful validation practices bring together engineering, manufacturing, regulatory compliance, and quality assurance to develop test solutions that are unique to each application. Developers of medical devices must validate the product design to ensure that it meets the user’s requirements. Manufacturers of medical devices must validate any process, including any associated equipment and software, whose entire output is not or cannot be fully verified by inspection. Critical processes that must be validated include material handling, assembly, chemical or biological processing, purification, testing, cleaning, packaging, labeling, storage and distribution.

Synergy Bioscience is experienced in the validation of many types of equipment, processes and systems used in a wide variety of medical device applications. We use a risk-based approach to validation that analyzes each risk for potential harm and likelihood of occurrence in order to focus testing around the most critical functions. To properly evaluate these risks, our staff includes engineers and scientists who understand the technical functionality of the process. We work closely with each client to tailor validation projects to their exact needs.

Synergy Bioscience can provide validation consulting for:

  • Pharmaceutical/Medical device design validation and transfer for manufacturing.
  • Equipment commissioning and qualification.
  • Facility and utility qualification.
  • Computer systems and medical device software validation.
  • Automation / control system validation.
  • Cleaning validation.
  • Validation of chemical processing and purification processes.
  • Medical device manufacturing validation.
  • Validation training for employees.
  • Laboratory equipment qualification.
  • Part 11 gap assessments.

To discuss how Synergy Bioscience can help you, please contact us.

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