Services
Process, Engineering and Validation Services
CEBIO Solutions provides high quality consulting services to meet your operational, quality and compliance needs. We specialize in Biopharmaceuticals manufacturing. Our experts can work with your team to Design, Contruct, Qualify and Operate new GMP facilities.
Computer Systems Validation
Computer Systems Validation is a formalized, documented process for testing computer software and systems, required by 21 CFR 11.10(a) and Annex 11, Section 4. The Health Canada, FDA and other regulatory bodies require validation to demonstrate that computer systems are in compliance with all regulations for electronic data management systems.
Our experienced validation professionals can validate all of your software, databases, spreadsheets, computer systems, and develop the appropriate documentation for all phases of the System Development Life Cycle. Our computer system validation experts have validated computer programs for all types of FDA-regulated businesses.
Our services:
- cGMP documentation
- Software validation and Testing - Computer systems validation services for ProCal, SAP, LIMS, Salesforce, Change management (Trackwise), and other business and laboratory data management systems
- Data Integrity
- MS Excel Spreadsheets - Spreadsheet security and compliance with 21 CFR 11
- Validation Documentation - Validation plan, BRD, URS, FRS, Traceability Matrix, Test Plans, Validation Reports
- Database validation
- Data modeling
SOPs
FDA regulations and electronic records compliance requires that the organization has formal documentation describing their business, quality and compliance practices. Our consultants can Review existing Policies, and author Standard Operating Procedures and Work Instructions to meet 21 CFR 11 requirements .