Frequently asked questions on FDA data integrity

Data integrity and compliance are nowadays the top priorities of all pharmaceutical companies. Data integrity and compliance in the pharma industry assures, quality and reliability of the manufacturing products.

Here, some frequently asked questions on FDA data integrity and compliance are listed below;

Frequently Ask Questions On FDA Data Integrity:

Some important questions on FDA data integrity are;

Question 1: What is “FDA Data Integrity”?

Answer: Data integrity refers to the completeness, consistency and accuracy of data. Complete, consistent and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).

Question 2: What is “Data life cycle”?

Answer: Data life cycle refers to How data is generated, processed, reported, checked, used for decision making, stored, and finally discarded at the end of the retention period.

Question 3: Is data integrity is applicable to contract issuer and contract acceptors?

Answer: The answer is “Yes”, good management program and assuring the data integrity is applicable to contract issuer and contract acceptors. Before accepting or giving an outsourced activity, all measures related to data integrity should be ensured.

Question 4: Why is quality risk management is required to ensure good data management?

Answer: The effort and resource assigned to data and record governance are commensurate with the risk to the product quality. A risk-based approach to record and data management ensures the adequate resources are allocated and control strategies for the assurance of the integrity of GMP data are in place.

Question 5: What is “original record”?

Answer: The first or source capture of data or information eg. an original paper record of a manual observation or an electronic raw data file from a computerized system, and all subsequent data required to fully reconstruct the conduct of the GXP activity. Original record can be static or dynamic.

Question 6: What is “true copy”?

Answer: A copy (irrespective of the type of media used) of the original record that has been verified (i.e. by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content and structure as the original.

Question 7: What is an “Audit Trail”?

Answer: A audit trail is a form of metadata containing information associated with actions that relate to the creation, modification or deletion of GxP records. An audit trail provides for secure recording of lifecycle details such as creations, additions, deletions or alterations of information in a record, either paper or electronic, without obscuring or overwriting the original record. An audit trail facilitates the reconstruction of the history of such events relating to the records regardless of its medium, including the “Who, What, When and Why” of the action.

Question 8: What is “meta data”?

Answer: Meta data is contextual information required to understand data. Meta data is often described as a data about data. Metadata is structured information that describes, explains or make it easier to retrieve, use or manage data.

Also read:

Stability Climatic Zones as per ICH Guidelines

Difference Between 21 CFR part 11 and EU annex 11

Question 9: What is “Static data record”?

Answer: A static term is used to indicate a fixed data document such as paper record or an electronic image.

Question 10: What is “Dynamic data record”?

Answer: Dynamic means that the record format allows interaction between the user and the record content.

Question 11: Can electronic signatures be used instead of handwritten signatures for master production and control records?

Answer: Yes, Electronic signatures with the appropriate control can be used instead of handwritten signatures or initials in any cGMP required record. This imports with 21 CFR part 11, which establishes criteria for when electronic signatures are considered the legally binding equivalent of handwritten signatures.

As per, 21 CFR part 11: Electronic signature and electronic records, permits electronic signatures instead of handwritten signatures and electronic records instead of paper records.

21 CFR part 11 regulations is a FDA’s regulation.

Question 12: When does electronic data becomes a cGMP record?

Answer: When data generated to satisfy a cGMP requirement, all data becomes a cGMP record.

Question 13: What is full form of “EDI services”?

Answer: EDI services full form is Electronic Data Interchange (EDI) services.

Question 14: What is EDI services?

Answer: Electronic Data Interchange (EDI) is the process of sending and receiving electronic business document between companies. This includes documents such as purchase order, invoices, shipment transactions etc.

Question 15: What are “EDI service providers”?

Answer: There are multiple EDI service providers in the market. Here are some example of EDI service providers:

  1. Mulesoftc edi service provider
  2. Dell Boomi edi service provider
  3. SPS Commerce edi service provider
  4. Youredi edi service provider
  5. cleo edi service provider

These are all top edi software provider in the market.

These are the questions on FDA data integrity that can help while interview.

Data integrity

For Interview Preparation: Interview Q&A

YT channel: Pharmabeej

Difference Between assay, potency and purity

ICH 14 guidelines in pharmaceutical

Leave a Comment