Get answers to the following questions: What do you mean by good documentation? What is the purpose of good documentation? What are the principles of good documentation?
Published 28 Apr 2022
Good documentation practices is a set of best practices for documentation and recordkeeping. It aims to preserve the data integrity of important documents and records and can also serve as guidelines for how to record information and store data appropriately.
Even outside of the pharmaceutical and manufacturing industries, information stored in documents and records is critical to the functioning of your business. Keeping the following information in order will help you manage your business more efficiently:
The purpose of good documentation practices is to ensure that businesses and organizations have good data or data that is Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA).
Data is incredibly powerful and good data allows you to:
But how do you get these benefits? Follow the ALCOA principles that make up data integrity and are the cornerstone of good documentation practices. Each principle is discussed in detail below.
Each letter in the ALCOA acronym corresponds to a characteristic of good data. These characteristics are the principles of good documentation practices.
What is it: Attributable means that you know where the data came from (who recorded it).
How to apply the principle:
What is it: Legible means that data is easily readable and understandable.
What is it: Contemporaneous means that data is current (applicable at the time of its access) and recorded in real-time (no delay between data generation and data recording).
How to apply this principle:
Data within Each Document
Date of creation
Date of recording
Date of revision
Date of correction
Date of review
What is it: Original means that data, once recorded, cannot be edited, altered, or erased.
What is it: Accurate means that data can be relied upon to be true, valid, and correct.
Two types of good documentation practices examples will be discussed. The first set of good documentation practices examples illustrates their importance and why you should follow them. The second set of examples shows what following good documentation practices looks like in action and will help you gain a clearer understanding of ALCOA principles.
Scenario: A regulatory authority has some follow-up questions for a business that recently submitted evidence of its compliance with a regulation.
Type of information: Evidence of compliance
Followed: Since the business immediately knows who recorded the compliance data, they are able to ask that person for more information and even have them answer the follow-up questions of the regulatory authority directly. The regulatory authority is able to confirm that the business is 100% compliant with the regulation.
Not Followed: Since the records submitted as evidence of compliance don’t identify the person responsible for creating them, the business is having difficulty finding more information on their compliance data. They are unable to answer the regulatory authority’s follow-up questions and are in danger of being deemed as non-compliant by the regulatory authority.
An employee is performing a critical task and needs to refer to the SOP for that task.
Type of information: Procedural documents
Followed: The employee is able to follow the SOP step-by-step since it was recorded electronically and even includes pictures and annotations to guide the employee. The employee performs the task correctly and the output of the task meets the client’s specifications.
Not Followed: Since the SOP is handwritten and the author’s handwriting is difficult to read, the employee merely guesses what some steps in the SOP are. As a result, the employee performs the task incorrectly and the output of the task is defective.
Scenario: An employee has to contact a customer to inform them that the specific item they wanted to purchase before is now in stock.
Type of information: Customer information
Followed: The contact number listed in the system is the customer’s actual contact number. As soon as the employee texts that number to inform the customer that their desired item is in stock, the customer immediately replies and places an order.
Not Followed: The contact number available to the employee is not the current contact number used by the customer. The employee doesn’t know this and keeps calling the old contact number. A significant amount of their time is spent on this.
If you’re ready to implement good documentation practices across your business but need extra guidance, refer to the information below.
Before you begin implementing good documentation practices:
If you’ve decided that your existing documents don’t need to follow good documentation practices or if you’ve already done the required steps to apply good documentation practices to existing documents, then you can begin the implementation of the following:
iAuditor by SafetyCulture is a data entry software that’s been included in Capterra’s 2021 Shortlist, GetApp’s 2021 Category Leaders, and Software Advice’s 2021 Frontrunners. iAuditor is free to download as a web-based software and as a mobile app. Here are some of iAuditor’s features for following good documentation practices easily:
Need help creating a digital document? SafetyCulture has a public library of 80,000+ free templates on a variety of use-cases. Customize any template to suit your needs and preferences or start using it immediately after downloading.
Download iAuditor for free.
With this template, you can quickly record data while still following good documentation practices. It allows you to do the following:
Use this signature log template to register the signatures of employees, contractors, and suppliers. You don’t need to get their signatures in-person. Simply give them “Inspection access” to the template and they can digitally sign from wherever they are. For each name and signature added to the template, you also have the option to put in the following details:
Zarina is a content writer and researcher for SafetyCulture. She enjoys discovering new ways for businesses to improve their safety, quality, and operations. She is working towards helping companies become more efficient and better equipped to thrive through change.
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