ScinoRx provides professional services that have the depth of experience in commissioning and qualification to ensure compliance with the applicable regulations and client requirements. We will integrate the ISPE Baseline Guide approach into the project development, complete validation life cycle, commissioning and qualification phases to stream line the qualification process. We provide consultants and services in following areas:
Validation
Validation is our niche. ScinoRx offers GxP quality and compliance services to resolve FDA enforcement actions. Our quality and compliance services help the biotech, pharmaceutical and medical device industries with their Quality Management Systems to ensure that their products consistently meet applicable regulatory requirements. We are extensively sophisticated in helping top organizations implement a broad range of software validation and verification based on 21 CFR Part 11.
- Computer System Validation
- Equipment Validation
- Cleaning Validation
- Process Validation
- Packaging Validation
- Thermal validation
- Sterilization Validation
- Aseptic area and clean room Qualification
- Analytical Equipment Validation
- Test method Validation
- Equipment Qualifications
- Facilities Commissioning and Qualification
- Equipment Commissioning and Qualification
- IT Infrastructure Qualification
- Design Validation & Verification
- Medical and technical writing
