Industrial Automation Software Development

Part 21 CFR Highlights

21 CFR is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Compulsorily used in Pharma Industry, DreamSoft has achieved full compliance in Industrial Software Application with 21 CFR.

Alpha Numeric Password with min 8 char.
Password ageing.
User Name and Password Encryption.
Wrong Password attempt account locking.
User login with same user name from different location will not be allowed
Auto Log out of no activity done.
User Access level.
Audit trail at each event with comments from user.
Digitally acknowledgement of Alarms with audit trails.
Digital Approval of Data with 2 level facilities along with Batch Approval facility.
a) Review Data Log.
b) Approved Data Log.
Electronic Signature : Printing of User Name at the bottom of Report with date and time of User who is generating the report, user who is authorizing data
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DreamSoft IT Solutions Pvt. Ltd.

105/106, Hinal,
Datta Mandir Road,
Dahanukarwadi Junction,
Kandivali (West),
Mumbai-400067.
India

Nirav Buch : +91 9870310606
Hiren Thakkar : +91 9821174015

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