Software
Software Validation Services
PharmOut IT can offer validation support to ensure that your computerised systems and software meet the rigorous requirements of the regulators.
PharmOut Information Technology does not consult to the industry. However, should you need practical advice on validation documentation for compliance to FDA 21 CFR parts 11, 210-211, 820, 606, ISO 9001; ISO 13485, contact our sister company PharmOut and farm it out.
Services
We can provide
- Validation Master Plans
- Corporate policies and procedures for 21 CFR Part 11 validation compliance
- User Requirements Specifications (URS), Functional Requirement Specifications (FRS), Design Specifications (DS), Configuration Specifications (CS)
- Traceability between specifications and testing protocols
- Objective methodologies for selecting Suppliers
- Assessment tools and audit checklist readiness
- Ongoing quality and Project Management
- SOP development and implementation
- IQ/OQ/PQ
E-mail:- info@pharmoutit.com