Commissioning, Qualification and Validation

We can set your validation program (strategy and approach), build upon your existing program or if needed provide staff augmentation due to aggressive deadlines.

We tailor your  solution based on your compliance needs and the complexity of your project. 

Our commissioning, qualification and validation services include  the following:

• Validation Master Plan/Risk-based strategies

• Construction Qualification

• FAT/SAT planning and support

• Cleanroom Qualification

• Manufacturing Equipment Qualification (IQ/OQ/PQ)

• Testing Equipment Qualification (IQ/OQ/PQ)

• Process Validation (PV)

• Cleaning Validation

• Temperature Mapping

• Sterilization Validation

• Shipping Validation

• Risk Assessment and Impact Analysis

Quality Assurance and Quality Systems

Whether your QMS requires agility, flexibility or standardization throughout different sites we can help you prepare the balance needed for your business to succeed.

Our quality assurance and quality system services include  the following:

• Develop QMS strategy

• Vendor Qualification

• Supplier Management

• Procedures Development

• Internal and External Audits

• Develop remediation plans

Project Management

We partner with our clients to fully understand the project’s goals, objectives, deliverables, resources, constraints. Then we develop plans that integrate project business drivers, scope of work, budgets, cash flow curves, resource loading and timelines that meet project goals and objectives.

Our project management services include  the following:

• Constructability and enhanced design reviews

• Project Execution Plans

• Scheduling

• Project Document/Control

• Commissioning Startup and Management