5 Top Data Integrity Risks & 6 ALCOA Mitigation Actions.

In this article, you will learn the most common data integrity risks and ALCOA mitigation activities associated with Document Management and the GDP FDA requirements.  Moreover, you can discover how to get a Document Management Procedure Template and Document Management Software Application to handle your GMP records activities fast and easily.

Top 5 Data Integrity Risks

There is an assortment of factors that can affect the integrity of the data stored in a file, database, spreadsheet, or application.

The most common data integrity risks are related to:

1. Human error: When individuals enter information incorrectly, duplicate or delete data, don’t follow the appropriate protocol, or make mistakes during the implementation of procedures meant to safeguard information, data integrity is put in jeopardy.
2. Transfer errors: When data can’t successfully transfer from one location in a database to another, a transfer error has occurred. Transfer errors happen when a piece of data is present in the destination table, but not in the source table in a relational database.
3. Bugs and viruses: Spyware, malware, and viruses are pieces of software that can invade a computer and alter, delete, or steal data.
4. Compromised hardware: Sudden computer or server crashes, and problems with how a computer or other device functions, are examples of significant failures and may be indications that your hardware is compromised. Compromised hardware may render data incorrectly or incompletely, limit or eliminate access to data, or make information hard to use.
5. Physical compromise to devices – Many malware are been affecting the intended use and operation of the electronic device firmware(s) to alter or affect the information.

Risks can easily be minimized or eliminated by doing the following 6 mitigation actions:

1. Limiting access to data and changing permissions to restrict changes to information by unauthorized parties.
2. Validating data to make sure it’s correct both when it’s gathered and used.
3. Backing up data.
4. Using logs to keep track of when data is added, modified, or deleted.
5. Conducting regular internal audits.
6. Using error detection software.

At CIQA, we can help you in technological aspects of achieving Data Integrity as well as the regulations (FDA, PDA, etc) for achieving data integrity compliance and ALCOA.

ALCOA is used by regulated industries to evaluate its compliance with data integrity and is essential to ensuring Document Control Management (DCM) and Good Documentation Practices (GDPs).

ALCOA applies to paper and electronic data.  For more information about ALCOA for electronic records, press here.

For more information questions and answers about Data Integrity Risks 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 ramon.cayuela@ciqa.net.

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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 FDA ALCOA Guidance for Data Integrity.

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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REFERENCES:

For more information about Data Integrity Risks, refer to:

httpss://www.fda.gov/files/drugs/published/Data-Integrity-and-Compliance-With-Current-Good-Manufacturing-Practice-Guidance-for-Industry.pdf

TITLE 21–FOOD AND DRUGS

SUBCHAPTER A–GENERAL

PART 11  ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

httpss://clarkstonconsulting.com/insights/guidance-data-integrity/

https://www.climet.com/data-integrity/

https://www.biopharminternational.com/data-integrity-electronic-records-according-21-cfr-part-11

httpss://www.pda.org/docs/default-source/website-document-library/chapters/presentations/missouri-valley/data-integrity-issues-concernse703e9d7a8c4657391feff0000cd242a.pdf?sfvrsn=4

httpss://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

httpss://www.fda.gov/media/118202/download

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.40

QS Regulation and Guidance • Quality System Regulation and Preamble

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/ucm230127.htm

Inspection Guide – Pages 8, 15, 21, 22 and 23

httpss://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074899.htm

Guide to Inspections of Quality Systems [Quality System Inspection Technique (QSIT)]

www.fda.gov/iceci/inspections/inspectionguides/ucm074883.htm