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Validation Engineering & Compliance Services

 
 
Validation and Compliance Services

Today’s increasingly difficult regulatory environment mandates that managers be proactive in order to avoid compliance issues that could seriously impact the bottom line. It is essential to have the appropriate systems and documentation in place to prevent unexpected regulatory compliance problems from draining valuable resources and capital from your core operation. Designing and implementing lean and scalable, cost-effective solutions is our specialty.
 
Arc Engineering professionals have a broad and deep understanding of compliance and quality systems. We have extensive experience both in auditing and improving existing programs and designing and implementing new ones. We believe that an effective system need not be overly complex. Inefficient use of resources is not tolerated in your manufacturing processes and it should not be tolerated in your compliance/quality systems.
 
At the same time, we realize that the integrity of these systems is of paramount importance. We insist on absolute integrity, while striving to minimize demand on resources. We design your program and resulting documentation to stand up to the most vigorous FDA scrutiny.

  
  
Equipment and Process Validation
If you already have a mature compliance/quality program in place, we can assist with your validation needs. In addition to developing validation protocols, we can execute installation qualification, operational qualification and performance qualification testing (IQ/OQ/PQ).
 
Unlike many non-engineer “validation contractors”, Arc Engineering professionals are able to provide engineering support during the validation process. We don’t simply inform you that your equipment or process failed and walk away. We work with you to identify and rectify the source of the problem.
 
Validation and Compliance Services Include
  • FDA Submissions and Responses
  • cGMP Criticality Review/Audit
  • cGMP and Regulatory Compliance Documentation
  • Quality Auditing/Assurance
  • Validation Program Design & Implementation
  • Validation Master Plan
  • Equipment Validation
  • Process Validation
  • Commissioning and Qualification
  • Protocol Development
  • SOP Development
  • Change Control
  • Corrective Action/Preventative Action (CAPA)
  • System and Component Risk/Impact Assessments
  • Temperature Mapping
  • Maintenance/Calibration Program Development

© 2011 Arc Engineering, LLC 229 E Michigan Ave 
Suite 245 
Kalamazoo, MI 49007-6402 
info@arcengineering.com 
(269) 207-2080