21 CFR Part 11 Compliance

Download Leaflet - Solutions for Lifesciences Industry


Our first 21 CFR Part 11 SCADA package was installed way back in 2007 in Serum Institute, Pune. We have over 12 years experience working with 21CFR systems in the industry. We understand and comply all URS’s of 21CFR Part 11, USFDA and Eudralex. Along with automation and SCADA we also understand the challenges of IT infra and configuration requirements of the customer, which enables to comply 100% with the URS.

We help End Users and Original Equipment Manufacturers (OEM) in this industry to comply with the most stringent norms that 21CFRPart11 demands. We have absolute clarity on this subject and with our experience of working in he Life sciences industry for more than 20 years, we can deliver systems with no liability to the end user from auditors.

Pinnacle Custom Reporting Tool

We have in house IT software development team that ensures any custom requirement of the customer to implement and ensure compliance. Our advance Reporting Tool ensures customer gets the correct and customised report with complete signature manifestations.

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

Audit Report

Batch Report

User Management

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