Good documentation practices are essential to your company’s pharmaceutical quality system and quality risk management strategies. These practices are helpful during a regulatory inspection, deviation investigation, or product recall. Good documentation practices are essential for receiving ISO 13485 certification or other ISO certifications.[1] These practices are not only important in pharmaceuticals but any type of business.

The acronym ALCOA+ is utilized to define what is required in good documentation practices. ALCOA+ stands for attributable, legible, contemporaneous, original, and accurate. In addition, it is recommended that data is also complete, consistent, enduring, and available. These assist with maintaining data integrity and quality.

Good documentation practices apply to all regions, products, and even digital systems. Digital recordkeeping systems are becoming more common. The computerized system and data collection process must be validated according to GMP guidelines and regulatory expectations. ALCOA+ requirements cover paper, electronic, and hybrid records as well.

It is required to perform an annual self-inspection of documentation, however, it is recommended to perform these self-inspections more frequently. Management must provide training and monitoring of documentation practices. More frequent internal audits can improve compliance and reduce the risk of findings.

During any FDA audit, you can nearly guarantee that the documentation procedures, recordkeeping systems, and data integrity compliances will be targeted. If your company needs assistance with its documentation training, EMMA International can assist. Contact us by phone at 248-987-4497 or by email at info@emmainternational.com.


[1] ISO, Guidance on the Requirements for Documented Information of ISO 9001:2015 Retrieved on Feb 27, 2022 from https://www.iso.org/files/live/sites/isoorg/files/archive/pdf/en/documented_information.pdf 

Bano Ahmed

Bano Ahmed

Bano is a Quality Engineer at EMMA International. She has experience in quality control, pharmaceutical and medical device manufacturing, and implementing corrective and preventative actions within the pharmaceutical and medical device industries. Bano has earned a Bachelor of Science in Biology from Pennsylvania State University and a MPH in Population Health Sciences from the University of Michigan.

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