In this article, you will learn the main characteristics of the objective evidence required by GDP Good Documentation Practices as per FDA requirements. Moreover, you can discover how to get a Document Management Procedure Template and Document Management Software Application to handle your training activities fast and easily.
The Top 10 Attributes of Objective Evidence Required by GDP are:
- Presentable record for human interpretation.
- Equivalently Reproducible and Repeatable.
- Tangible proof.
- Interpretation can be agreed to by most people. Documentation can be easily read and understood independently of other documentation.
- Allows for subsequent reaffirmation (independence of verification).
- Sufficient to reach a pass/fail conclusion.
In Addition, Exist 9 Types of Objective Evidence Required by GDP:
At a minimum, any one or a combination of the following types of objective evidence is acceptable.
- Handwritten statement. The author provides a handwritten statement that describes the actual results of the execution. Care should be taken to write legibly.
- Recommendation: The handwritten statement should clearly identify any differences between the expected results and the actual results.
- A filled-in blank. The author provides a specific area and instructions to record the specified data or result. Typically, the data or result is compared to an expected result provided by the author.
- Recommendation: When there is a clear mismatch between expected and actual results, no further explanation is required; however, the association shall provide any additional comments that are helpful to the interpretation or analysis of the actual result, if available.
- A pre-populated field. The author incorporates a pre-populated value that is pre-approved for correctness prior to execution and provides a means of enabling the associate to indicate whether that value matches the actual results.
- Recommendation: The associate shall document where any differences exist between the pre-populated value and the actual result. This can be done by identifying differences directly in the step or by providing a screenshot of the actual result and indicating the differences, or any other method that clearly documents the difference(s).
- Screen Print Shot. The author provides instructions for the associate to capture a static image display or screen, which is attached to the documentation.
- Recommendation: The associate shall document where any differences are between the expected results and the actual image directly on the screenshot.
- Screen Video Recording. The author provides instructions for the associate to capture a video image or dynamic display, which is attached to the documentation.
- Recommendation: The associate shall document where any differences are between the expected results and the video display screen recording.
- Witnessed observation. The actions of the associate are observed during execution and the witness additionally verifies actual results against expected results. This can be done in real-time with a witness present to observe the execution, or it can be provided by video image capture and later replay. The witness must also sign and date the executed step or provide some other means of authorization of their activities.
- Recommendation: The associate and/or witness shall clearly identify any differences between the expected results and the actual results by hand-writing on the evidence, by providing a screenshot and indicating the differences, or any other method that clearly documents the difference(s).
- Data file. The author provides instructions for the associate to capture a data file, which is attached to the documentation package, either as an electronic file or as a hardcopy printout of the data. The data must be captured in a human-readable format, or a method must be provided for an independent review of the data within the intended context of the data capture.
- Recommendation: The associate should document where any differences are between the expected results and the data on the printout of the data file or use any other method that clearly documents the difference(s) objective evidence required by GDP.
- Printout. The author provides instructions for the associate to generate a printout, which is attached to the documentation package.
- Recommendation: The associate should identify where any differences are between the expected results and the printout or use any other method that clearly documents the difference(s).
- Other. While the above list is broad, it likely does not cover all record needs. If another method is devised for providing objective evidence required by GDP that meets the attributes specified above, then it may be used with prior approval of a management quality representative.
For more information, questions, and answers about objective evidence required by GDP and Compliance With Drug CGMP Guidance for Industry press here.
CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. His experience includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, and quality assurance. Specific questions about Document Control Management DCM or quality system training can be directed to CIQA at firstname.lastname@example.org.
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Three (3) Options to Create Document Control Management DCM Procedures:
Bronze Option. You Can Create Your Own Quality Procedures, using a Template.
You can download samples of the Document Control Management DCM procedure templates in .pdf format.
To see the complete list of the most popular quality procedures templates, click here.
In addition, you can request a quotation to buy online a full SOP template document in MS Word format that is completely editable, ready to fill and adapt to your specific needs.
Silver Option. We Can Bring You a Formal Training on Objective Evidence Required by GDP Good Documentation Practices.
This option is recommended if you want to learn more about how to build robust quality system procedures. One of our expert(s) can provide online step-by-step training to your team (unlimited assistance) on how to build reliable SOPs using our template(s). Also, you can improve your corporate quality procedures and policies by incorporating our template(s) and tools. It includes a fully editable template from the Bronze option, plus training, exams, and a training certificate for each assistant. Request a quote now.
Gold Option. We Can Create Customized Quality Procedures.
One of our expert(s) will create and prepare your customized SOPs with the inputs and specific information of your company. It includes a fully editable template from the Bronze option, plus online support in document creation, implementation, and training. Request a quote online.
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For more information about Objective Evidence Required by GDP Good Documentation Practices, refer to:
TITLE 21–FOOD AND DRUGS
PART 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
QS Regulation and Guidance • Quality System Regulation and Preamble – Objective Evidence Required by GDP Good Documentation Practices.
Inspection Guide – Pages 8, 15, 21, 22 and 23
Guide to Inspections of Quality Systems [Quality System Inspection Technique (QSIT)]