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Tag: 21 cfr part 11 compliance
Electronic Batch Records for Digital Pharmaceutical Compliance
Batch Manufacturing Records (commonly known as EBR’s) have been the backbone of lot and batch traceability for pharmaceutical companies for decades and have been a vital part of the manufacturing due diligence process to meet strict regulatory standards.
North America
SG Systems LLC
4101 McEwen #240, Dallas TX 75244
Phone: +1 214 819 9570
Contact us here
United Kingdom
SG Systems Europe Ltd
Suite 3 Walton Summit Centre, Green Place, Four Oaks Rd, Preston, PR5 8AY
Phone: +44 (0) 114 349 1480
Contact us here
Australia
Wedderburn
101 Williamson Road, Ingleburn NSW 2565
Phone: +61 2 9426 1800
Contact us here
Europe
SG Traceability Systems Ltd
31-32 Greenmount Office Park, Harolds Cross, Dublin D6, Ireland
Phone: +44 (0) 114 349 1480
Contact us here
Registered in USA - 800749944 | Registered in UK - 09208889 | Registered in Ireland - 732738
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The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network.
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The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user.
Statistics
The technical storage or access that is used exclusively for statistical purposes.
The technical storage or access that is used exclusively for anonymous statistical purposes. Without a subpoena, voluntary compliance on the part of your Internet Service Provider, or additional records from a third party, information stored or retrieved for this purpose alone cannot usually be used to identify you.
Marketing
The technical storage or access is required to create user profiles to send advertising, or to track the user on a website or across several websites for similar marketing purposes.
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Functional Always active
The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network.
Preferences
The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user.
Statistics
The technical storage or access that is used exclusively for statistical purposes.
The technical storage or access that is used exclusively for anonymous statistical purposes. Without a subpoena, voluntary compliance on the part of your Internet Service Provider, or additional records from a third party, information stored or retrieved for this purpose alone cannot usually be used to identify you.
Marketing
The technical storage or access is required to create user profiles to send advertising, or to track the user on a website or across several websites for similar marketing purposes.