Considering the amount of documentation that is required for pharmaceutical companies, efficient document management is essential.
Pharmaceutical document management can be defined as a repository of all the documents that your organization (be it pharmaceutical, biotechnology, or clinical research organization) will be generating, handling, and maintaining during the entirety of a drug development process, be it a new drug, diet, or a new treatment.
It is the foundation for your organization’s pharmaceutical quality management system. This also means that you have a legal obligation to keep track of all documents related to the production and distribution of the products in compliance with certain documentation standards. This also includes the FDA 21 CFR Part 11 in case you use an electronic system for managing documents.
The fact that we have built an all-in-one QMS software for life science organizations and have helped pharmaceutical companies of all sizes, and from all parts of the globe, to smoothly transition from paper-based QMS systems to digital QMS solutions means that we know a thing or two about pharmaceutical document management.
In this article, we will discuss the main requirements for pharmaceutical document management, the advantages of effective documentation processes, and some of the benefits of digital document management solutions.
But first, let’s start with the basics:
- What is Pharmaceutical Document Management?
- What Are the Benefits of Effective Pharmaceutical Document Management?
- What Are the Regulatory Requirements for Pharmaceutical Document Management?
- Things to Consider When Implementing Effective Pharmaceutical Document Control
- Choose the Right Pharmaceutical Document Management Software
What is Pharmaceutical Document Management?
Pharmaceutical document management can be defined as a system that captures, stores, and tracks all the documents related to the development, production, and distribution of pharmaceutical products.
It can be considered one of the most critical components of your organization’s pharmaceutical quality management system.
When your organization is involved in the process of developing a new treatment, a new drug, or a diet, you will be generating a large number of documents. These documents need to be safely and efficiently maintained for the purposes of auditing and to show to your internal and external stakeholders that the product being developed is both safe and efficacious.
Recommended Reading: What is Document Control in Life Sciences?
What Are the Benefits of Effective Pharmaceutical Document Management?
The benefits of effective pharmaceutical document management are many and varied, but can be summarized in the following 5 benefits:
- Compliance: With effective pharmaceutical document management, your organization will be up-to-date with all regulatory requirements. This will ensure better audit readiness, which in turn will lead to fewer compliance issues. There would be almost no time wasted when you submit your documents, for example, an Investigational New Drug Application.
- Efficiency: Your organization will be generating thousands of documents throughout the lifecycle of a product. When you manage your documents effectively, you will not lose documents, all details will be traceable, and it will be easier to find the documents you need when you need them. You will not lose valuable person-hours because the human error will be reduced. If your company is investigating several drugs at the same time, efficient pharmaceutical document management practices will ensure that there is no mix-up of the documents – documents about one product will be completely separate from the others.
- Single source of truth: All documents will be available in one place. This will ensure that different departments within your organization are working from the same set of latest documents. This will avoid confusion and discrepancies, and everyone will be on the same page, figuratively speaking.
- Security: Effective pharmaceutical document management will ensure that all documents are safe and secure. Only authorized personnel will be able to access pertinent documents.
- Faster time to market: The effective pharmaceutical document control system in your organization will ensure that precious time is not wasted, as a result, you will be able to get your products to market faster.
All these benefits can be even more effectively realized by implementing a cloud-based document management solution that provides a centralized document repository with complete security and control, like SimplerQMS.
SimplerQMS provides pharmaceutical eQMS software with robust document control capabilities, designed to help you manage your documents more effectively and efficiently while ensuring compliance with all the applicable regulatory requirements.
It provides features such as document version control, revision control, document workflows for document authoring, review, approvals, archiving, the FDA 21 CFR Part 11 compliant electronic signatures, time-stamped audit trails, and more.
What Are the Regulatory Requirements for Pharmaceutical Document Management?
Several regulatory guidelines describe how pharmaceutical organizations should go about managing their documents. The main ones are the following.
International Council for Harmonisation (ICH) E6
The introductory section of essential Documents for the conduct of a clinical trial as per ICH E6 (R2) Good clinical practices states that:
“Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements. Essential Documents also serve several other important purposes. Filing essential documents at the investigator/institution and sponsor sites in a timely manner can greatly assist in the successful management of a trial by the investigator, sponsor and monitor. These documents are also the ones which are usually audited by the sponsor’s independent audit function and inspected by the regulatory authority(ies) as part of the process to confirm the validity of the trial conduct and the integrity of data collected.”
ICH E6 states that your organization will need to maintain essential documents that will permit the regulatory agencies to evaluate the conduct of the clinical trial, and the quality of the data produced.
These documents need to be filed in a timely manner for the successful management of the clinical trial.
Current Good Manufacturing Practice Regulations
The Current Good Manufacturing Practice (cGMP) regulations are enforced by the FDA.
Amongst other things, it ensures that your pharmaceutical organization will establish strong quality management systems (including documentation) that will ensure that medications are manufactured using adequate controls.
To learn more about cGMP, you can read our article explaining what are Current Good Manufacturing Practices (cGMP).
FDA 21 CFR Part 58
The GLPs that your organization must have for the conduct of nonclinical laboratory studies that will support research or marketing of human and animal drugs, medical devices, and others are enshrined in the FDA 21 CFR Part 58.
FDA 21 CFR Part 210
FDA 21 CFR Part 210 states:
“The regulations set forth in this part and in parts 211, 225, and 226 of this chapter contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess.”
As described above, these requirements will ensure that your organization will, at the minimum, will practice cGMPs for the manufacture, processing, packaging, and holding of drugs.
FDA 21 CFR Part 312
As per the FDA CFR Part 312:
“This part contains procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the Food and Drug Administration of investigational new drug applications (IND’s). An investigational new drug for which an IND is in effect in accordance with this part is exempt from the premarketing approval requirements that are otherwise applicable and may be shipped lawfully for the purpose of conducting clinical investigations of that drug.”
FDA 21 CFR Part 314
As per the FDA CFR Part 314:
“This part sets forth procedures and requirements for the submission to, and the review by, the Food and Drug Administration of applications and abbreviated applications to market a new drug under section 505 of the Federal Food, Drug, and Cosmetic Act, as well as amendments, supplements, and postmarketing reports to them.”
Both the FDA 21 CFR Parts 312 & 314 govern the use of investigational new drugs.
When we look at the regulatory requirements for pharmaceutical document management, we see that there is overlap across many regulations and standards.
However, the main requirements can be summarized as follows:
- Document control procedures: A dependable and standardized way in which the organization will manage all documents, from creation to obsolescence.
- Document control requirements: The need to maintain and regularly update essential documents that will be submitted to regulatory agencies.
- Filing of documents in a timely manner: This will ensure the successful management of the clinical trials.
The above is a high-level overview of the regulatory requirements for pharmaceutical manufacturers regarding documentation. To get a professional and comprehensive understanding of your specific needs, it is best to choose a knowledgeable pharmaceutical consultant.
FDA 21 CFR Part 11
As per the FDA 21 CFR Part 11:
“Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations. Part 11 also applies to electronic records submitted to the Agency under the Federal Food, Drug, and Cosmetic Act (the Act) and the Public Health Service Act (the PHS Act).”
21 CFR Part 11 is important when your organization is maintaining documents using an electronic system. It will also apply when you are submitting these documents electronically to the US FDA.
A crucial prerequisite of 21 CFR Part 11 is the validation of the electronic system that you have for maintaining accuracy, trustworthiness, and uniformity of data.
To ensure compliance with 21 CFR Part 11, you must ensure that your electronic system meets requirements regarding:
- Record generation
- Audit trails
- Operational controls
- Electronic signatures
- Security controls
- And more
To learn more about 21 CFR Part 11 and how to ensure compliance if you use an electronic document management system, read our article on the FDA 21 CFR Part 11 software requirements.
SimplerQMS was purposefully built for life science companies with complaince in mind. The system helps companies in the pharmaceutical industry meet international regulatory requirements for document control, including Current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and others.
With SimplerQMS you are assured of automatic version and revision control of all your documents, as well as a complete audit trail of all the activities related to each document. The software also supports 21 CFR Part 11 compliant electronic signatures, providing a complete solution for your document management needs.
Things to Consider When Implementing Effective Pharmaceutical Document Control
The following tips will help you implement an efficient pharmaceutical document management system in your organization.
Evaluate the Current Document Management System
Currently, you may have written policies for document management in your organization. It is possible that these policies may be incomplete or lacking in one or more details.
You need to look out for the following:
- Out-of-date versions of guidelines: For example, your organization is relying on FDA 21 CFR Part 312 dated 28-02-2019, whereas the latest version is dated 07-07-2022.
- Incomplete documents: If you have continued with the traditional paper-based manual system of documentation, and only recently transitioned to an electronic QMS, you may not have incorporated FDA 21 CFR Part 11 guidelines in your document management system.
- Irrelevant documents: Some areas of your organization such as billing and finance do not come within the scope of pharmaceutical document management. Yet, your current document management system may contain these.
A thorough analysis of your current document management system will help you understand the need to update, streamline, or remove irrelevant documents. This restructuring will save your organization both time and money in the long run.
Implement an Automated Pharmaceutical Document Management Software
When you evaluated your current pharmaceutical document management system, you may have come across one or more lacunae such as the following:
- Out-of-date documents
- Absence of current guidelines
- Presence of irrelevant documents
The implementation of automated pharmaceutical document management software could help you ensure that this does not happen in the future.
The system will help you in the following ways:
- Automate the process of document management: The software will automate the various tasks involved in document management such as the creation, routing, review, approval, and archiving of documents.
- Ensure timely updates of documents: The software will ensure that all your documents are always up-to-date. It will also send alerts to the concerned personnel whenever a document is due for revision.
- Provide easy access to documents: The software will provide easy and quick access to documents from any location and at any time.
- Facilitate collaboration: The software will enable easy collaboration between different departments and personnel within your organization.
- Provide access control: The software will provide different levels of access to documents based on the role of the personnel. For example, only people involved in the manufacturing process will have access to the SOPs for manufacturing.
- Ensure security: The software will ensure that all your documents are secure and can only be accessed by authorized personnel.
- Improve compliance: The software will help you improve compliance with international regulatory guidelines such as FDA 21 CFR Part 11, cGMP, GCP, GLP, and others.
Plus, many automated pharmaceutical document management systems allow you to easily integrate with your existing enterprise solutions like Customer Relationship Management (CRM), an Enterprise Resource Planning (ERP) solution, and others.
Utilize Document Forms and Templates
It is a well-known fact that pharmaceutical companies take years of research to get new drugs, medications, etc. into the market. This involves the generation of tons of documents.
When you use pre-approved document forms and templates, your scientists and research staff will be able to focus on their work and not waste time on documentation. Additionally, you will be able to standardize your documents and reduce the risk of errors.
Here are some of the examples of document forms and templates that you can use in your organization:
- Preclinical phase templates and forms could include participant recruitment forms, informed consent forms, or Memorandum of Understanding (MOU) forms.
- Templates from the clinical phase would typically include investigators’ brochures, clinical study protocols, and case record forms.
- Post-marketing phase templates are those that capture relevant information on adverse events (e.g. deviations, complaints, and corrective and preventive actions) they include but are not limited to, product complaint forms, non-conformance report templates or deviation forms, and CAPA form templates.
SimplerQMS allows you to create and manage document forms and templates with ease. Then create documents using those forms and templates with just a few clicks, and edit them in Microsoft Word, Excel, or PowerPoint.
You can import your own forms and templates or use our pre-approved forms and templates.
Employ a Document Controller
You may also consider hiring a document controller/document control specialist.
This person(s) will be responsible for the complete document control procedures in your organization. Document control is the practice that you follow to create, review, distribute, and dispose of documents in a provable and structured manner.
The document controller will integrate and promote quality into all aspects of documentation in your pharmaceutical organization. This person(s) will do document control, document archival, and updating of all documents independently or with minimal guidance.
You may consider employing a document controller when your organization is planning to expand to new markets or when you are planning to transition from your current document management system to an automated QMS platform.
Establish a Single Source of Truth
The documents that are generated and shared with stakeholders, including regulatory agencies, are the single source of truth about the processes, protocols, and procedures that you are following during the manufacture of products.
An effective pharmaceutical document management system will highlight this truth.
The core benefits of having a single source of truth are:
- Centralized repository of all documents: All your organization’s documents will be stored in a central repository. This will make it easy for personnel to find and use the documents.
- Improved version control: Maintain different versions of documents and track the changes made to them. This will help you ensure that only the latest version of a document is in use.
- Improved communication and collaboration: More streamlined communication and collaboration between different departments and personnel will lead to better decision-making.
- Enhanced traceability: Easily trace the history of a document and track who made what changes to it. This will be helpful during audits.
With the SimplerQMS software solution, you are ensured of full, time-stamped audit trails, a centralized file repository, and broad QMS process support. You can learn more about our pharmaceutical document control software on our website or schedule a tailored demo.
Choose the Right Pharmaceutical Document Management Software
Nowadays, organizations that continue to maintain the traditional manual pharmaceutical documentation systems are exposed to a plethora of challenges.
These include, but are not limited to, time and labor-intensive, security issues, storage problems, error-prone documentation, compliance issues, and in the current scenario, environmental issues with a ton of papers, inks, and so on.
When you implement the SimplerQMS software solution, you are provided with pharmaceutical document management software that has been designed specifically for organizations such as yours. You get a secure, cloud-based, streamlined document management process that helps ensure regulatory compliance with international regulatory requirements such as GCP, cGMP, GLP, FDA 21 CFR Part 11, and others.
The SimplerQMS software solution will automate the steps of creation, reviewing, approval, and distribution of all documents.
Some of the key features include version and revision control, electronic signatures, controlled printing, full audit trails, and a secure centralized document repository.
These features allow your organization to efficiently manage all your documents and gain better visibility into the status of your Quality Management System.
As a result, you will save precious time and money, ensure compliance, and access the market quicker than your competitors.
When you are in the business of manufacturing drugs that affect the lives of people, you must ensure that your pharmaceutical documentation management is streamlined, efficient, and up-to-date.
Your stakeholders, including the regulatory agencies and the end-users, rely on the veracity of these documents. Your brand name is reliant on these documents that form the crux of your quality management system.
It is not easy to have a manual paper-based documentation system and not expect issues to crop up. When you have an efficient pharmaceutical document management solution, like SimplerQMS, you are assured of automated workflows, compliance with applicable regulatory requirements, and the proficient management of all your documents.
If you are keen on streamlining your pharmaceutical document management processes – book a personalized demo and talk to our quality solution expert to see how SimplerQMS can help you!