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Food, Healthcare, Pharmaceutical and Cosmetics industries are under strict supervision of FDA, which was solely formed to ensure the quality of the products of Food, Drug and Cosmetics industries. FDA has strict validation rules, quite a few of which apply to electronic systems that maintain the manufacturing or handle any FDA regulated products. Some of the imposed regulations are 21 CFR Part 11 which emphasize on electronic signatures. Apart from this, the requirements are to maintain documentation and keep the IT system validated.
In addition businesses need to keep their eyes and ears open for any new regulatory procedures introduced by the government. More like a full time job, adding to the costs. To state the obvious, regulations like FDA Validations, SOX Compliance make sure organizations understand the need for responsible IT systems and infrastructure.

In order to maintain validated systems, NGTech offers the following solutions:

  • Change control Management
  • Change control Training
  • Documentation Support
  • Validation Training and Support
  • Auditing Services
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