¹Title 21 CFR 211.68.

²General Principles of Software Validation; Final guidance for Industry and FDA Staff, FDA, Jan. 2002. Guidance for Industry Part 11 Electronic Records; Electronic Signatures – Scope and Application, FDA, Feb. 2003.

³GAMP Guide for Validation of Automated Systems, Ed. 4, ISPE 2001.

⁴GAMP 5 A Risk-Based Approach to Compliant GxP Computerized Systems, ISPE, 2008.

⁵Guidance for Industry: PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance, FDA, Sep. 2004.

⁶Ostrove, S.: Qualification and Change Control. In: Validation of Pharmaceutical Processes, 3rd Ed; Editors: Agalloco, J, Carlton, F. New York: Informa Healthcare USA, Inc., 2008, Chapter 46, pp. 619–628-145.

⁷Data Integrity and Compliance with CGMP, Guidance for Industry, FDA, April, 2016.

⁸Technical Report No. 18; Validation of Computer Related Systems, Parenteral Drug Association, 49(S1); 1995.

⁹NOTE: Ladder logic and source codes need to be reviewed for compliance to good code writing requirements. Two of the items that should be included in this review are a review for dead code (ie, code that has no use but may cause errors in the program when run) and annotation. Ladder logic (the programming code used for PLCs) should be reviewed for functionality as well as annotations. While the source code of higher systems (PCs, etc.) also needs to be reviewed (eg, for dead code but also for annotation of the sections).

¹⁰Title 21 CFR Part 11, 2015.

¹¹Part 11 guidelines.

¹²Title 21 CFR 11.10, 201.

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