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| Regulation, Specification, or Guidance
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Requirement
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21 CFR Part 211.103
21 CFR Part 226.40 (d)
WHO Technical Report Series, #986, Annex 2, 16.4 and 16.20
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16.1 The system should be able to calculate and record theoretical and actual percentage of yield at various phases of processing, manufacturing, and packaging.
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| 21 CFR Part 211.103
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16.2 The system should provide a means for verification and approval of yield calculations before release for reporting.
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21 CFR Part 820.20
21 CFR Part 820.40
21 CFR Part 820.186
E.U. Commission Directive 2003/94/EC Article 11
WHO Technical Report Series, #986, Annex 2, 1.0
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16.3 The system shall be able to maintain a production facility's quality system in a specific quality system record, in accordance with regulations and guidance such as 21 CFR Part 820.20 and 820.40 (U.S.), E.U. Commission Directive 2003/94/EC Article 11 (E.U.), and WHO Technical Report Series, #986, Annex 2, 1.0 (global).
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21 CFR Part 820.30
21 CFR Part 820.120 (e)
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16.4 The system shall be able to create a design control document capable of recording the details surrounding device development, including control number, physical and performance requirements, final output, review, verification, approval, transfer, changes, and complete design history.
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21 CFR Part 820.181
21 CFR Part 820.184
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16.5 The system shall be able to create a device master and device history record capable of recording all information described in 21 CFR Part 820.181 and 820.184.
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21 CFR Part 211.105 (b)
21 CFR Part 211.130 (e)
21 CFR Part 211.134 (c)
21 CFR Part 211.188
21 CFR Part 211.20 (d)
21 CFR Part 211.50 (c)
21 CFR Part 225.102
21 CFR Part 225.202
21 CFR Part 226.80
21 CFR Part 226.102
21 CFR Part 820.60
21 CFR Part 820.70 (a)
21 CFR Part 820.80 (c)
21 CFR Part 820.120 (d)
E.U. Commission Directive 2003/94/EC Article 9.1
FDA Hazard Analysis Critical Control Point Principle 2 and 4
FDA Hazard Analysis Critical Control Point Principle 7
WHO Technical Report Series, #986, Annex 2, 2.1 (a) and (f–g)
WHO Technical Report Series, #986, Annex 2, 15.25–30
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16.6 The system shall be able to create a batch production record capable of recording complete information regarding batch production and control details such as, but not limited to, a unique batch or production run number, formulation, specific labeling and packaging, production steps, in-process and laboratory control results, the unique identifier of any equipment used, persons performing and/or supervising operational steps, and the results of any pre-process or post-production inspections.
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