The FDA released a Guidance for Industry: 21 CFR Part 11, Electronic Records; Electronic Signatures, Scope and Application. “When persons choose to use electronic records in place of paper format, Part 11 would apply”. The importance of Part 11 is directly tied to compliance with predicate rules such as the Current Good Manufacturing Practice (CGMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP) regulations.
21 CFR Part 11 SCADA package, We have experience on working with Environment Monitoring systems (EMS) in the industry with automation and SCADA system. we provide solution with SCADA package as per customer requirement, which enables to comply 100% of FDA guidance.
Environment Monitoring System with SCADA
Our SCADA package & Environment Monitoring System (EMS) ensure the customer requirement and also implement & compliance.
21 CFR Part 11 SCADA Features
- Security & E-Signature Features
- Audit & Alarm Reports
- Electronic Batch Reports
- Auto Data Backup
- RAID Hardware with IPC (Industrial PC)
- Validation Documents
- IT System / OS Security
- Complete GAMP5 Implementation
- Signature Manifestation
Documentation
- Compliance of URS
- Functional Design Specification (FDS)
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Opearational Qualification (OQ)
- Valve Matrix
- FAT Procedure
- Risk Assessment
- Disaster Recovery
- Electrical Panel Drawing
- User Manuals