|
Synertec assists clients in Validation activities ranging from simple ‘as built’ documentation to complete process qualification for complex manufacturing environments.
Synertec can develop your high level Validation Master Plan and follow through to execution of the validation protocols.
Our extensive manufacturing experience and our thorough knowledge and understanding of regulatory requirements has assisted many clients to achieve and maintain compliance. Our projects are regularly audited against the requirements of the regulators.
We are committed to providing the latest thinking in a cost effective and practical manner. The right approach can reduce validation costs.
Our areas of expertise include:
- Computer System Validation
- Equipment Validation
- Analytical Method Validation
- Raw Materials Specifications
- GMP Principles
- Cleaning Validation
- Final Product Testing
- Risk Assessment
- Design Qualification
- Installation Qualification
- Operational Qualification
- Performance Qualification
- Validation Master Plans
- Process Qualification
|
