TISPL provides PLC/CS Validations in accordance of GAMP-5 guidelines. validations on PLC, SCADA, DCS,labs. Excel sheet & so on.
Computer System Validation / PLC Validation is becoming Very Essential / Mandatory for the Life Science Companies as Current GAMP 5 Regulation are becoming very Stringent.
Here we can support you with our Vast Experience in this field. We validate your Systems in Cost Effective Manner to ensure all Predicate Rules are satisfied withProper Documentation of Complete Activity.
Our Protocols are based on GAMP 5Guidelines. We are providing following Documentation.
• Computer System Master Validation Plan
• Gap Analysis & Risk Assessments
• Installation & Operational Qualification.
• Traceability Matrix.
• Related SOP’s.
We have performed Computer System Validation of following System in Leading Pharmaceuticals Companies all over India. Most of these Companies are cleared there Local & International Audits like USFDA, MHRA,TGA etc.
• Programmable Logic Control (PLC )
• Supervisory Control & Data Acquisition (SCADA) Systems
• Distributed Control Systems ( DCS )
• BMS Automation System Validation
• Computer Based Systems in Laboratory like – HPLC, GC, Stability Chambers etc.
• Data Acquisition Software for different Process / Equipments.
• Excel Sheet Validation
• Laboratory, Clinical or Manufacturing Database Systems