In depth assessment of the current state of compliance with respect to the systems, policies, SOP’s, procedures, it’s rectifications, remediation measures followed by coaching and training.

We work with our partners to develop systems and procedures, which are user friendly and at the same time in accordance with the current regulatory requirements of various global agencies. This activity is done together with the members on the shop floor to have a better understanding and thereafter an easier implementation and usage.

We can carry out the gap analysis and identify the areas that need improvement and accordingly its remedial action with respect to compliance to 21CFR Part 11, which is mandatory if any business wants to maintain records on an electronic platform and use electronic signatures.

The following areas shall be considered for the above:

Manufacturing
Engineering
Warehousing
Quality
R&D
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