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Documentation

Tapasya assures quality product with good documentation practices. In a cGMP environment documentation needs to meet certain requirements to ensure product quality and product safety. The cGMP regulations from FDA, PIC/S and EU all include mandatory sections on documentation.

Documentation provides both:

  • Information on when, where, who, why, and how to complete tasks, and
  • Evidence proving that the tasks have been completed as they should be documents provide the information or evidence or may serve as an official record.

Tapasya's Documents Includes:

Drawings
  • Assembly and Erection Drawings
  • Equipment Support Drawings
  • Drawing of schematic and piping arrangements
  • Drawings for Air Handling Unit Instrument
  • Data sheets loop diagrams
  • General Assembly drawings
  • Electrical and Pneumatic drawings
  • Process & Instrumentation diagrams & necessary layouts
  • Final As-built Drawing
  • Contact surface area drawing
Certificates
  • Material of construction reports
  • Certificates for all direct / indirect product contact surfaces
  • Instrument calibration reports or certificates
  • Integrity test certificate
  • Guarantee / warranty certificates for the equipment and bought-out items
Operation manuals
  • Operation and maintenance manuals for the main equipment as well as all the bought out items
  • Operation and maintenance manuals for the major components Software ladder logic / operation and controls
  • Software manual
  • Instrument manual
  • Equipment manual and trouble shoot guide manuals
  • Interlock description flow charts for operation and maintenance
Protocols and qualification documents
  • Factory Acceptance Test protocols
  • Design Qualification
  • Installation Qualification
  • Operation Qualification
  • Installation instructions/ guidelines
  • Recommended SOP's for operation, cleaning and maintenance
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Global Operations
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