Validation & Verification


Validation & Verification

Compliance and Validation Solutions for Manufacturing and Packaging

Compliance and validation are keys to success in highly regulated and complex industries. As a leader in manufacturing and packaging solutions – particularly within the pharmaceutical and medical device industries — Clarke Solutions specializes in and provides all-inclusive solutions for validation and verification. This includes commissioning and qualification projects for small-scale equipment, large-scale equipment, full-line installations, cleaning systems, facilities, utilities, etc. We streamline validation and verification processes with first-time success and maximum schedule adherence.

Our validation and verification services include:

FDA Change Management: Change management is one of the key elements that make up a pharmaceutical quality system. It is becoming increasingly difficult for companies to manage the peaks of activity that occur with significant changes related to capital projects, facility and equipment maintenance, process improvements, and general regulatory requirements.  Clarke’s highly trained teams enable clients to augment internal teams with engineers who understand what it takes to effectively manage change.

Commissioning and Qualification: Commissioning and qualifying for a major capital project in the pharmaceutical and life science industries is a daunting task. In today’s environment of increased focus on compliance, increased pressure on time to market, and the business benefit of trouble-free operation, this has never been more important.

Computer System Validation (CSV): Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements. Validation of computer systems to ensure accuracy, reliability, consistency of intended performance, and the ability to discern invalid or altered records is a critical requirement of compliance in pharmaceutical manufacturing.

Validation Life Cycle Support: Per FDA requirements and guidance, continued process verification is a requirement of validation. The integration of development work, process conformance, and continuing verification provides assurance that the product or process will consistently remain in control throughout an entire product life cycle. Clarke Solutions can help with this validation process, from the beginning through ongoing changes in a life cycle.

Validation and verification is an integral aspect of manufacturing and packaging in the life sciences industries, and Clarke Solutions can provide you with expert services and solutions needed for success in your field. Contact us online or call 317.849.0330 today for a free, no-obligation assessment.

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