Regulatory Compliance
San Diego County has earned the moniker “Biotech Beach” for its profusion of biotech, pharmaceutical and medical device manufacturers. In these industries, IT operations are held to a higher standard of control by regulations and industry standards.
At sdBOStechs we understand that for these industries, development and testing requirements are more rigorous and the additional documentation required can be voluminous. That’s why we offer specialized Regulatory Compliance services to clients who want to stop worrying about the compliance of their IT and focus on their business.
sdBOStechs provides the following Regulatory Compliance services:
- Validation Planning & Management
- Augmentation of your Existing Validation Project Team
- Policies and Procedures for IT Compliance
- Validation/Verification of Regulated Systems
- Electronic Record/Electronic Signature Validation
- Compliance Assessment and Remediation Plans
- Quality System Audits for Vendors and Service Providers
- Risk Assessment & Management for Computerized Systems
Industry Experience and Expertise
Our support staff includes an ASQ-certified Software Quality Engineer with over 10-years of experience in the interpretation and application of regulations that apply to software and computerized systems in both pharmaceutical and medical device manufacturing.
