Sound Services
SOUND highly skilled professionals have a wide range of experience in the pharmaceutical, biotechnology, and medical device industries. Let our group's solid and sound technical expertise present you a solution that fits your size and budget. Feel free to contact us, we’d love to help.
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