Due to the strict regulatory oversight faced by pharmaceutical and medical device manufacturers, thorough, accurate documentation has long been one of the biggest priorities for businesses operating within these industries.
For these types of manufacturers, good documentation practices (GDocP) are ingrained in all work processes and operations, ranging from research and development to the actual production and final testing. During this time, manufacturers systematically prepare, review, approve, issue, record, and store documents detailing every activity undertaken to produce pharmaceutical products.
In more traditional pharma manufacturing businesses, documentation practices lean towards a more manual, paper-based approach. However, modern pharmaceutical manufacturers have digitized their documentation practices, making for a more robust document management system.
Regulatory bodies like the FDA also have input into the documentation process across the entire industry, ensuring that the public – the final product end consumer – receives high-quality products safe for use.
This guide shines a light on good documentation practices, providing pharmaceutical manufacturers with the basics for managing data from the various facets of the manufacturing operation.
What are good documentation practices?
Good documentation practices (GdocP) are a specific subset of GxP principles focused on the consistent, accurate record keeping involved in the production of various types of products.
GdocP is particularly important for manufacturers of life science products due to the sensitive nature of the items produced and the potential impact on consumers’ health.
As a result, such manufacturers are required to show how their products are manufactured from the materials and ingredients used to the date the product was created, the batch it was part of, and the personnel who were involved. Pharmaceutical manufacturers undertake recordkeeping practices detailing the activities implemented when producing medications, medical devices, and other related products.
Good documentation practices can involve various approaches medical manufacturers use to assert and improve data veracity and integrity. These practices ensure that manufacturers collect and record data comprehensively and appropriately, keeping the business on the right side of regulatory bodies.
Additionally, the data collected by manufacturers can come in many different forms, including but not limited to documents like bills of materials, logsheets, certificates of compliance, laboratory notebooks, checklists, standard operation procedures, and validation documents.
Requirements for good documentation practices
For pharmaceutical manufacturers to achieve GDocP, there are a few basic requirements they need to keep in mind. These include:
Responsible personnel should record entries at the time the activity takes place.
All entries should be accurately dated and timestamped.
The person entering data into documents should sign against their entries. In other words, an individual who isn’t directly responsible for the work shouldn’t sign for another.
Records shouldn’t be destroyed; they’re necessary for future compliance audits.
Original or raw data should always be retained.
These requirements boil down to the ALCOA principles, enabling pharmaceutical manufacturers to implement good documentation practices required by regulators and standards bodies.
How ALCOA principles apply to good documentation practices
The goal of ALCOA is to ensure improved data integrity, placing pharmaceutical manufacturing businesses on the path to achieving good documentation practices as required by regulatory bodies. ALCOA is an acronym that is broken down as follows:
Attributable: All document entries should be attributed to someone in the organization. Therefore, documents must have signatures unique to the individual, with details showing the person’s responsibility.
Legible: Documents must be able to be read by compliance auditors and other authorized individuals. In the case of handwritten documents, visible ink should be used. Additionally, the person should have competent penmanship, ensuring that the entries can be easily read and understood.
Contemporaneous: Dates, initials, signatures and other seemingly perfunctory data shouldn’t be added to documents before the core activity takes place.
In other words, documents should be filled at the same time as the activity being recorded, ensuring that the document refers to the most current data.
Original: The master document requires direct data from the activity. In addition, mistakes during data recording shouldn’t be erased or covered. Instead, the direct person recording should be the only one to correct it.
Also, the mistake should still be legible, ensuring that the record shows the mistake’s existence in the first place.
Accurate: Data should be recorded strictly as observed. This means that documents shouldn’t have extrapolations or expectations not observed during the activity. In addition, any calculations applied to the data must also be recorded.
In some instances, it’s prudent to add some context to the data collected, presenting more valuable information to those reading the document.
Streamlining GDocP efforts with software
Given the complexity of pharmaceutical and medical device production processes, utilizing manual, paper-based record-keeping techniques can present several problems to good documentation efforts.
Most businesses opt for digitizing their documentation processes, utilizing software for their various recordkeeping endeavors. Digital documentation solutions provide multiple benefits that make the process more manageable.
For instance, digital tools act as central repositories for critical documents, making storage and accessibility more manageable. Additionally, this feature enables collaboration amongst authorized individuals in various departments. This is particularly possible due to cloud storage, providing remote access to documents.
Digital tools also streamline good documentation by reinforcing the ‘Attributable’ part of the ALCOA principles. The software logs all document changes, ensuring each edit is attributable to a unique user. This also grants more enforceable user access to sensitive documents.
And because software covers all GDocP requirements, it makes the compliance audit less challenging, providing detailed document history for regulators to peruse.
How Tulip can help improve your documentation
Tulip is used by a number of Fortune 500 life sciences manufacturers to track and manage their operations.
Using our platform businesses are able to automate data collection at every stage of production, ensuring that all of the pertinent details are accounted for and documented resulting in more streamlined compliance procedures. Some of our platform features include:
Electronic records and signatures - Tulip is compliant with both FDA CFR 21 Part 11 and EMA EudraLex Annex 11.
Digital audit trail - Quickly access and view data for every action captured for a batch, product, or piece of equipment.
Contextual, immutable data - Once captured, your data is never lost. Using Tulip, you can collect data from multiple sources to gain full visibility of your operations.
Approval Workflows - Enable efficient review and approval of only required aspects as defined by your business.
Automatic Attributability - Automatically capture data for all your regulated use cases including batch records, device records, equipment logs, and more.
If you’re interested in learning how Tulip can help streamline compliance procedures and improve your documentation efforts, reach out to a member of our team today!
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