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.

pReport

pReport is our in-house flexible reporting tool for customized reports as per 21 CFR Part 11 guidelines. It is perfect complement to our SCADA software and helps cater to demands of customization from the End Users.


pSecure

pSecure is for complete user management as per 21CFR part 11 guidelines. It helps complete the user management functions as per GAMP5.


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

pReport - Audit Report

pReport - Batch Report

pSecure - User Management

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