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SSW770-FDA  | | S.E.A.M.scan Module - FDA Edition enhances our industry-leading S.E.A.M.scan Inspection Software, helping companies needing to meet FDA criteria for their digitally stored can and double seam measurement data.
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21 CFR Part 11, first issued by the Food and Drug Administration on August 20, 1997, states the FDA’s requirements for Electronic Records and Electronic Signatures. The S.E.A.M.scan Module - FDA Edition enhances our industry-leading S.E.A.M.scan Inspection Software, helping companies needing to meet FDA criteria for their digitally stored can and double seam measurement data. ( see www.fda.gov/ora/compliance_ref/part11 …Pages 36-38)
An Electronic Record is any combination of text, data and graphics presented in digital form that is created and archived by a computer system. 21 CFR Part 11 requires controls be in place to ensure the authenticity and integrity of these records. The S.E.A.M.scan Module - FDA Edition enhances data security by:
- Providing an electronic signature that is linked to every inspection, containing user name, password, date, time, signer’s legal name and signature meaning;
- Sealing an inspection that has been digitally signed so it cannot be altered;
- Encrypting each digitally signed inspection and appending it to a redundant tamper-proof database;
- Auditing by comparing the original inspection to its encrypted version. Any discrepancies are noted in a message warning that data integrity may be compromised; and by
- Ensuring that Double Seam and Line Specifications are permanent once an inspection has been signed.
An Electronic Signature is a series of characters (i.e. – username and password) that are adopted by an individual as a legally binding equivalent to their handwritten signature S.E.A.M.scan Module - FDA Edition improves digital information security by allowing an individual to authenticate their measurement data, and then “seal” the inspection record with their digital signature.
The S.E.A.M.scan Module - FDA Edition seamlessly integrates with the S.E.A.M.scan Inspection Software, S.E.A.M.scan Module - Image Maintenance and S.E.A.M.scan Module - SPC Analysis software components.
Minimum Requirement: S.E.A.M.scan Inspection Software
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