We supply full documentation to meet strict IT standards and regulations. Our experienced team will write clear, concise documents and implement testing plans for your organization as well as specialized equipment qualifications to ensure compliance requirements. Planesia's resources have had experience in the Pharmaceutical and medical devise industries and have worked with packaging, manufacturing, laboratory, and utilities projects.
Our IT Compliance practice includes:
- Computer System Testing for regulated applications
- Development and execution of testing documentation (Test Plans, Protocols, Standard Operating Procedures)
- Testing Project Management
- Gap analysis
- Quality Assurance policies and procedures
- Technical and business documentation such as Job Aids
- Data Flow Diagrams
- Workflow Diagrams
- Disaster Recovery Plans
- Business Continuity Plans
- User Manuals
- Business Analysis
- IT Policies and Procedures
- Third party and supplier Audits
- Evaluation of the effectiveness of your quality system
- Evaluation of the effectiveness of your supplier quality system