COMPLIANCES OF USFDA 21 CFR PART 11

We have a collective experience of around 20 years of working on 21 CFR systems in industry. Due to the increasingly frequent use of automatic systems in managing production processes in systems that operate under FDA approval, automation and control systems are realised in conformance with the CFR21 Part 11 regulations. We at Invensys Pharma Technologies understand the need of customer and provide the customer centric solution to comply with their URS.

Our clarity and experience on the subject enables us to provide the correct solution and achieve the critical requirements of the guidelines. From designing, developing, deploying, commissioning and validating we provide the complete solution package to customer end.

KEY FEATURES PROVIDED BY INVENSYS

• E- signature
• Audit and Alarm records
• Security and Password complexity as per 21 CFR part 11
• E – records
• Data backup and Restoration
• Scalability for IT system (LDAP integration)
• Centralized Networking solutions
• Customized reporting solution for Date/Batch/Shift wise report.
• Documentions for system validations
  
  • FAT/SAT
  • FDS, DQ
  • IQ, OQ, PQ
  • Risk Assessment
  • Electrical and Hardware drawings
  • Operating & User Manuals.
• Strong, efficient and quick after sales services.