In the life sciences industry, document control denotes the processes and strategies used for managing the many different documents that move within the organization, amongst investors and sponsors, and regulatory agencies throughout the lifecycle of the product.
Documentation is crucial to prove the safety and effectiveness of your organization’s products such as medical devices and pharmaceuticals. Documentation will prove the dependability, reproducibility, and repeatability of the processes. With documentation, you are efficiently communicating what has to be done, when it has to be done, and how it has to be done.
These are the topics we will cover:
- Document Control Definition
- Document Control Requirements
- Document Control Procedures
- Importance of Document Control
- How to Achieve Effective Document Control
- What Is a Document Control Software
- Document Control Automation
- Frequently Asked Questions on Document Control
Document Control Definition
Document control can be defined as a series of practices that ensure that documents are created, reviewed, distributed, and disposed of in an organized and verifiable manner.
You might also use the term “document management”. While these terms are closely related, they are not interchangeable.
Document management indicates the systems and processes your organization has put in place for maintaining and managing documentation. It is the storage, location, tracking, updating, and sharing of documents.
Let us look at some examples from the life sciences industry to get a better understanding of document control.
A memo is displayed in the production line of your pharmaceutical company detailing modifications to be made to an existing production process. The memo is a duplicate of information that is kept under controlled specifications elsewhere. Now consider that further changes are made to the controlled document. But, the memo continues to carry obsolete information because it is not controlled. You either start controlling the memo or destroy it immediately!
In another example, the training department of your medical devices company has prepared a revised and updated training module for incoming new employees. Considering the importance attached to such a module, it must be controlled, and every change documented.
Document Control Requirements
Since effective document control is the mainstay of the life sciences industry, several international guidelines and standards govern it.
They include FDA 21 CFR Part 820.40, ISO 13485:2016, the European Union’s medical device regulation (EU MDR), FDA 21 CFR Part 11, and GxP.
FDA 21 CFR Part 820.40: This standard from the US Food and Drugs Administration refers to document control for medical devices companies that are manufacturing or selling products in the US market. Such companies must institute and maintain procedures for the control of all relevant and related documents that are emphasized in the FDA’s Quality System Regulations (QSR).
ISO 13485:2016 Section 4.2.4 (Control of Documentation): This International Organization for Standardization’s guideline provides the standards for medical devices quality management systems (QMS). The particular section highlights the importance of document control throughout the lifecycle of a medical device.
Furthermore, ISO13485:2016 also contains the requirement for Computer System Validation, (Section 4.1.6, General requirements) which is relevant for organizations that use computer software, such as an eQMS or Document Management System to manage their documents.
You should keep in mind that both the above-mentioned standards have substantial commonalities. So, as your organization starts complying with one standard, you will also be preparing for the other standard.
Recommended Reading: Quality Management System Documentation
Key Features for Control of Documents as per ISO 13485:2016 and FDA 21 CFR Part 820
- The organization must identify the most suitable person(s) for evaluation of all procedures concerning relevant documents
- All document control approvals must include signatures of approvers and the date
- All applicable points of use must have the up-to-date version of the document
- Changes, if required, must be reviewed and approved by the same person(s) who were involved in the original review and approval
- Approved changes in documents must be communicated to all relevant users
EU MDR: The latest medical device regulation applicable to the European Union has many points concerning document control. There is an emphasis on the lifecycle of the product in totality. This includes post-market surveillance, which is the set of activities that your organization will do to collect and evaluate the capabilities gained from your medical device that is already in the market and to identify if any further action needs to be taken.
FDA 21 CFR Part 11: Electronic record systems and signatures are probably part and parcel of your organization, and you will have to comply with this FDA standard.
Even if you are wholly paper-based, but still send documents via email, you will have to comply with the US FDA Code of Federal Regulations (CFR) Part 11, Title 21, which states that organizations that use one or other form of electronic record must:
“secure computer-generated, time-stamped audit trails to independently record the date and time of operator entries, and actions that create, modify, or delete electronic records.”
Furthermore, FDA 21 CFR Part 11 also has specific requirements for areas such as Validation, Record Generation, Audit Trails, Operational Controls, and Security Controls.
GxP: This is a collection of quality regulations and guidelines to ensure that products manufactured by the life sciences industry are safe, appropriate for their envisioned use, and abide by all quality practices during their manufacture, control, storage, and supply.
GxP is an acronym for Good (x-variable depending on application- for example, C: Clinical; L: Laboratory; M: Manufacturing; S: Storage; R: Review….) Practice.
The US FDA established GxP for ensuring that pharmaceutical, biotechnology, and medical devices companies conform to the following:
- Accountability – ability to pinpoint the person(s) responsible for the processes and procedures
- Traceability – ability to trace all processes from procurement of raw materials through their development history as a medical device/drug
- Data integrity – ability to rely on the data that is generated
Document Control Procedures
With document control, your organization will manage all documents throughout their lifecycle. It means that it is a dependable, standardized, and organized way of organizing documents, data, and information.
So, you will have a set of procedures for document control and a person(s) who will be responsible for document control. The content of these procedures is dependent on if you are using an electronic system for tasks such as numbering, versioning, and archiving.
Therefore, ask your eQMS vendor to supply a document control procedure, which is aligned with the relevant regulations as it will save you time.
The key steps in the document control procedure are:
- Creation of the document
- Review and approval
1. Creation of the Document
Your organization will determine the person(s)/departments responsible for creating documents and how these documents are to be created. You will also include the details for formatting the document, it’s naming, version history, and other technical details.
2. Review and Approval of the Document
The document control procedure in your organization will also give a detailed explanation of how the prepared document must be reviewed and who are the responsible persons to approve it. Also, how the approvals and modifications should be recorded will be highlighted in the document control procedure. You should be aware that all documents must be reviewed for accuracy before publishing.
3. Revisions to the Document
Please note that even after documents are approved and finalized, they may need changes in the future. Once again, your document control procedure will highlight the process for revising documents.
The emphasis here is on who has the authority to initiate or request revisions, and who will do the actual revisions. The procedure will also define the methodology for identifying a document according to its revision. Only the current and approved document must be published and the older versions must be obsoleted.
4. Publishing the Document
Once you have finalized and approved a document, the next step is to publish it. Your organization’s document control procedure will define the parameters to be followed for publishing a document and the persons authorized to access it. Also, the security restrictions on a published document will need to be well-defined.
5. Obsoleting the Document
This is a crucial step in the lifecycle of a document.
Older versions of a document, as determined by date or version history, are removed from accessibility.
Importance of Document Control
Once your organization has perfected the process of document control, you will leverage multiple benefits.
Your life science company will have multiple documents with numerous applications at several locations. With document control, you will be able to organize and track these documents and ensure that only relevant documents are placed in the correct locations.
For example, you cannot have a document concerning the production line of your medical device/drug placed where clients can access them.
With efficient document control, you are spared a lot of trouble and headaches!
All your employees will be working from the same relevant documents and standards.
Let’s say that your organization has initiated a policy of paid paternity leave for all eligible employees. However, the relevant documents have not been published in all departments. Disgruntled employees will raise a hue and cry.
The most up-to-date version of all documents must be published and older versions obsoleted.
For example, your post-marketing studies have shown that with a bit of fine-tuning, your pulse oximeter will work better. But if the relevant document is not available with the production team, you will still be marketing a less efficient pulse oximeter.
Similarly, based on inputs from clinicians, your pharmaceutical company has modified the dosage of a life-saving drug. You still need to revise the relevant documents and make the relevant personnel aware of this fact.
Your organization will have to comply with all relevant national and international standards/guidelines that were highlighted in a previous section. For this purpose, you must be able to produce the relevant documents on demand. There cannot be excuses about lost documents, irrelevant documents, and so on.
Let us take the hypothetical scenario of a disgruntled employee in a key department. The person may access sensitive documents and send them out via email or carry the information on an electronic device.
Also, we should be aware of external hackers. You can prevent this from happening by establishing security protocols in your document control system so that there is no unauthorized access to sensitive information.
With good document control, your organization will ensure that every single document and all versions are readily and easily accessible.
For example, there is a problem with a new stage in the lifecycle of your medical device or a pharmaceutical product. If previous versions of the documents are accessible, you can trace every step in the production cycle, identify issues, and rectify them.
7. Enhanced Responsiveness
When organizations understand the need for good document control and initiate steps to achieve it, they become proactive.
They can stay a step ahead of regulations rather than fumble through a damage control mode.
How to Achieve Effective Document Control
Now that you know what document control is all about, let us take a look at some of the most important aspects of effective document control.
1. Hire a Document Controller
A document controller/document control specialist is the person responsible for all document control procedures. If your organization is a mid-sized or a large one, you may have more than one document controller. Since the role requires technical proficiency in more than one area, it is advisable to have several document controllers.
2. Choose the Correct Document Control Software
With a proper Document Control Software solution, your organization will have an advantage over your competitors.
Such software can safely store all crucial documents in the cloud and should have the tools for data organization and easy search, navigation capabilities.
The software must support different document types, including PDFs, Word documents, image files, spreadsheets, and others. Another important aspect you will need to consider is that the software must be fully compliant with FDA 21 CFR Part 11.
Another important requirement for most life science organizations is that the Document Control Software is Computer System Validated – in compliance with FDA 21 CFR Part 11 and eventually ISO 13485:2016.
3. Have a Procedure for Document Control
As already mentioned in the sub-section on ‘Document control procedures, your organization must have a proper manual of document control procedures for achieving effective document control.
Therefore, make sure to ask your Document Control Software vendor if they can provide this document.
4. Continuous Improvement Is Needed
As your organization becomes more established, you will need to improve and update your document control management.
The rebuilding process can appear daunting, but by breaking each process into manageable tasks, you can achieve it more easily than you thought possible.
What Is a Document Control Software
Document control software allows your organization to automate records of all management policies, regulate access to sensitive information, and have thorough information of the activity of all documents for auditing and submissions.
When you substitute your paper-based document control procedures for an electronic document control software (EDMS), you will have a system wherein quality and compliance are guaranteed. With such EDMS, you can manage information and files following regulations and standards like FDA and ISO.
In the case of the life sciences industry, EDMS is typically referred to as an Electronic Quality Management System (eQMS). EQMS helps you manage all your QMS processes.
Let us look at a couple of examples from the life sciences industry to understand this better.
Because of the current pandemic, a pharmaceutical company is facing a shortage of staff on-site. However, this isn’t a problem since their eQMS allows for remote accessibility through a web-based application, 24/7.
Your medical devices company is facing issues concerning certain specifications to be incorporated into a new medical device. With an eQMS, you can record quality issues you are facing in different departments and solve them easily.
With an eQMS such as SimplerQMS, you will not only manage all your QMS processes confidently, but you will also have enhanced decision-making abilities, visibility, and preparedness for FDA 21 CFR Part 820, ISO 13485:2016, the EU MDR, FDA 21 CFR Part 11, and GxP.
The SimplerQMS eQMS solution allows for seamless collaboration between your organization and others (vendors, clients, and regulatory agencies), better standardization, simplified review and approval processing, and efficient interfacing with Microsoft Office Suite.
Recommended Reading: How to Choose Quality Management Software?
Document Control Automation
With the help of an eQMS such as SimplerQMS, several stages of document control are impacted beneficially.
1. Document Creation and Routing
Automation helps in differentiating between documents, such as policy documents and design documents.
They are then allocated their workflow, routing, review, and approval. Therefore, the document is reviewed and approved by the right people.
2. Document Version Control
Automation will help in the change request process that guarantees that all version changes to a document are according to the processes defined by your organization.
Document Control Software will safeguard that all changes related to a given document are in a single workflow. Also, older versions of the document are automatically archived.
All internal and external users are automatically alerted when the required information has arrived/been processed and it’s their time to take action.
4. Document Backup and Disaster Recovery
Data backups are executed automatically, every 15 minutes, and stored in multiple locations around the world, and monitored by professionals 24/7.
You avoid storing these documents physically in your organization and you have a ready insurance policy against the loss or damage to these records.
Frequently Asked Questions on Document Control
As a first step, identify all documents in your organization. Next, you will establish ownership and the quality standards for these documents. You will then systematically name and classify the documents for proper storage and retrieval. You will also need to create revision protocols and regulate access and security for these documents.
A document controller/document control specialist is responsible for all document control procedures. Such a person is needed only if you have a paper-based document control system in place. In case you have invested in an EDMS/eQMS, a document controller becomes redundant.
Information is the lifeblood of all organizations, be it life sciences or otherwise. For efficient functioning and regulatory purposes, there must be a proper flow of information. Such information is kept up-to-date, accurate, accessible, and is aligned with the nature of your business with proper document control protocols and procedures.
Document version control is the process by which you will track and manage different versions of a given document. You will know what the latest iteration of a given document is.
When you work in the life sciences industry, you will be dealing with information day in and day out. This information must have a proper flow, be accurate, accessible, secured, and up-to-date. All this is possible with proper document control protocols and procedures.
With eQMS such as SimplerQMS, your organization will not only manage all QMS processes assuredly, but you will also have enhanced decision-making abilities, visibility, and preparedness for national and international regulatory standards such as the FDA 21 CFR Part 820.40, FDA 21 CFR Part 11, ISO 13485:2016, EU MDR and GxP.