Quality & Compliance
- IT Management
- Quality & Compliance
- MS SQL Server/BI
- Oracle Business Suite
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Quality & Compliance Services
Baanyan can work with your senior staff to develop a Compliance Program that includes high level policies for Quality Management and System Development Life Cycle as well as involving Sarbanes-Oxley Act (SOX) compliance. We can design a custom program specific for you or work within any of the industry standards such as GAMP 5, QSR 820.
Baanyan can also audit existing programs and develop a gap analysis and remediation report outlining any deficiencies and/or risks within those programs and recommend remediation activities to eliminate those risks. Baanyan can also provide validation of GxP application hosted in cloud, as IaaS, PaaS or SaaS solutions which will provide compliant hosting.
Baanyan can provide Computer Systems Validation Services for GxP applications for pharma Industry. We have highly trained employees providing an alternative solution to clients who are looking to outsource the validation/ testing portion of their System development Life Cycle.
- Equipment qualification
- Technical writing - plans, protocols and reports
- SOP - preparation and modification
- Documentation auditing
- Equipment (IQ, OQ, PQ)
- Facility / Utility
- Computer System and Software
- Commissioning, start-up and qualification for production facilities, including utilities, equipment and control systems.
- Protocol Development / Execution
- 21 CFR Part 11, electronic records/electronic signature
Baanyan understands FDA regulations and how to successfully manage and deliver appropriate remediation activities. Our team has the expertise in compliance remediation solutions and has the resources to assist you in achieving positive outcomes with the FDA