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21 CFR Part 11

Posts about 21 CFR Part 11
Home / Blog / 21 CFR Part 11
How Sepha products simplify pharmaceutical regulatory compliance

21 CFR Part 11, Data Integrity, electronic records, electronic signatures

How Sepha Products Simplify Pharmaceutical Regulatory Compliance

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How to navigate 21 CFR Part 11 complians risks - Sepha blog

21 CFR Part 11, Compliance

How to Navigate 21 CFR Part 11 Compliance Risks

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21 CFR Part 11, Data Integrity, Compliance

How Sepha Products Ensure Data Integrity in Pharma

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What is 21 CFR Part 11 and why does it matter

21 CFR Part 11

What is 21 CFR Part 11 and why does it matter?

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Founded in 1980

SEPHA has established a global reputation for innovation and development of specialised, high quality equipment for use in the manufacture of pharmaceutical blister packs, medical device and healthcare products. Our products enable customers to create high quality blister packs, to accurately detect leaks and weak seals in packaging, and to recover high value products from blister packs.

Products

  • Leak Testing
    • MediScan
    • Multi-Q
    • PakScan
    • VisionScan 3D
  • Deblistering
    • PressOut Manual Wide
    • PressOut Semi-Automatic
    • PressOut Universal
    • PressOut Universal Mini
    • Clic-Open Ampoule Opener
  • Packaging
    • EZ Blister
    • EZ Blister+
    • EZ Blister MAP
    • EZ MedPak

Connectivity

  • MESConnect

Container Types

  • Blister Packs
  • Bottles
  • IV Bags
  • Vials
  • Ampoules
  • Pre-filled Syringes
  • Flexible Packaging
  • Medical Device Packaging

Standards & Regulations

  • ASTM F2338-24
  • ASTM F3169-16
  • USP 1207
  • 21 CFR Part 11

Test Methods

  • CCIT
  • Vacuum Decay
  • Pressure Decay
  • Force Decay
  • Vacuum Deflection
  • 3D Volumetric Measurement

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