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 Compliance Consulting Services

Online provides technical services and compliance consulting services and solutions. Our mission is to deliver commissioning, qualification, validation, and compliance consulting solutions to ensure the successful delivery of projects critical to your business success.


Commissioning and Qualification Services

Since the release of the Commissioning and Qualification Baseline® Guide in March 2001 by the International Society for Pharmaceutical Engineering (ISPE), the pharmaceutical industry has been embracing the guideline as a standard for pharmaceutical engineers to follow as part of good engineering practices and as a strategy to meet current FDA expectations.

Our validation engineers are experienced in executing commissioning and qualification activities for clients that are starting up new facilities and expansion of existing production capacity as required to bring their products to market.

Regulatory Compliance Consulting Service

The FDA-regulated industry must comply with strict regulations (i.e., GMP’s; Quality System Regulation) to meet current FDA expectations. Failure of pharmaceutical manufacturers to comply with current GMP’s and the FDA’s expectations may result in a variety of negative business-related impacts.

Online’s services eliminates the risk of FDA enforcement in our clients’ operations. The demand for our compliance consulting services to assist our clients mitigate the risk of non-compliance has been increasing due to a growing number of pro-active executives making Online an integral part of their operational plan and journey towards operational excellence.

To help our clients achieve a higher level of compliance, we provide a number of services including:

• FDA / GMP Compliance Reviews
• FDA Inspection Planning
• Quality System Policy and Procedure Development
• Quality System / GMP Audits
• Quality System Policy Assessments
• Quality System Review and Design Services
• GMP Training
• Validation Audits
• Validation Program Assessment
• Validation Master Planning

Equipment Qualification, Facility Qualification, Utility Qualification

Online has experience in the planning, managing, and executing commissioning and qualification projects for clients in the pharmaceutical, biopharmaceutical, and medical device industries. As regulations, standards and guidance have evolved; we keep our teams current and adjust our approach to keep our clients compliant.

Our teams support each client’s engineering and quality organizations by developing validation documents, such as, validation plans, user requirement specifications, functional requirement specifications, design qualification, commissioning test plans, system impact assessments, component impact assessments, factory acceptance tests, installation qualification, operational qualification, performance qualification, process validation, etc., as needed for compliance with today’s engineering best practices.

We have a diverse base of experience in developing facility qualification, equipment qualification, and utility qualification protocols for our client’s projects associated with many different types of products (medical devices, pharmaceutical, and biopharmaceutical) and including all of today’s technologies and process and utility system equipment and controls. The documents prepared include:

 

  • Commissioning Plans
  • Validation Plans
  • HVAC Qualification Protocols
  • Environmental Monitoring Performance Qualification Protocols
  • Facility Qualification Protocols
  • Utility Qualification Protocols
  • Equipment Qualification Protocols

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