Speaker 1: In this short course, you will learn the basic rules of maintaining and managing your documents using a document management system. We will use the ISO 9001 standard as a base. ISO 9001-2015 requires that organizations maintain documented information to prove the effectiveness of their quality management system. What does document control mean? Maintaining documented information means that you have organized the documents that make up your quality management system with the most up-to-date information in a user-friendly and simple way. These documents should be available for all employees who need to refer to them in their work. Creating and updating documented information is the process of recording data in a defined and clear manner and in the appropriate medium, paper or electronic. An appropriate document management system needs all procedures and specifications to be outlined and identified for monitoring purposes and for future reference. You must also ensure documents are reviewed and approved for suitability and adequacy. This approach promotes adequate document control and consistency at the point of use. Now let's review the main requirements of a proper document control system. Documents and records must have titles. Each one should have unique identifiers and version controls. The unique identification will indicate the document's identity. This will distinguish one piece of documented information from another, revealing which ones address which topics. To facilitate the identification process, the document title should have a standardized document label created with an alphanumeric prefix to differentiate types of quality records. For example, the title of the first standard operating procedure, SOP, might begin with the prefix SOP01, indicating the type of the quality record and its serial number. Other prefixes can be used to indicate the type of document, for example, Kappa 01 for corrective and preventative actions or WI01 for work instructions. After a document is created, an employee with an appropriate job role must review and approve the documented information before it can be used. This can be done by using manual or electronic signatures or other types of approvals. Creation, review and approval must be traceable. This means it must be clear who performed what. Documents should also be protected from tampering and from unauthorized changes. This reduces the risk of integrity problems when someone is making reviews or approvals under somebody else's name. Regarding distribution, documents should be made available at the appropriate locations and point of use. Approved employees should be able to find the documents easily and understand how to access them. If a computer or electronic device is used, a best practice in some industry is to use an electronic system where employees must enter their username and password to access

Speaker 2: the documents. The medium must be accessible and understandable.

Speaker 1: It can be paper or electronic. If the medium is electronic, then users need to have access to a computer or other electronic device that can display the content. The format must be appropriate for the purpose and the intended users, with each page displaying the page number and the total number of pages for clarity and reconciliation.

Speaker 3: Documents should be stored systematically for easier retrieval.

Speaker 1: Your organization should specify where the documented information is located. The location must be accurate and verifiable, with controls in place to preserve the information. This can take substantial effort if the documents are in paper format. The storage and retrieval of digital documents is relatively easy. Please note that storing the documents is not enough.

Speaker 3: Documents need to be protected from theft or security breach.

Speaker 1: Preservation guarantees the integrity and content of documents and ensures they are available during the retention period. Legibility is a top priority throughout the life of the document. If paper documents are used, be sure to prevent alteration or damage. Many paper documents are prone to damage over time due to torn pages, rust from paper clips or improper storage containers. The paper might turn yellow, the ink might fade, or high humidity might even disintegrate the document. Documents can also get lost or misplaced. A fire or natural disaster could mean the loss of essential information with no option of retrieval. This is why periodically backing up your quality documents is a crucial step in your recovery plan. Having a robust backup strategy ensures business continuity no matter the circumstances. You have a paper backup system in place? Maintaining paper documents is generally costly and more of a hassle.

Speaker 3: Opt for electronic documents when possible.

Speaker 1: Is the access control of your documentation physically and digitally impenetrable? Access indicates permission to view the documented information or the authority to view and change the documented information. Your organization needs to establish a policy around what information and which documents can be accessed for each job role. Remember though that not everyone needs to access the same information. Security measures are also important. What if there is malicious intent from an employee? You should establish access restrictions to the documentation repository. This may sound cynical, but in this day and age, many regulations require that the activity is controlled and tracked. How frequently should my documents be updated? Typically, documents are updated whenever you need to adapt the content to the reality of the process. If things do not change that often, then the review process should take place based on what you have established in your policies. A 24-month review is usually acceptable. When a document goes through several changes over a period of time, you will need to differentiate the older versions from the newer ones. The document change control tracks how many changes the document had, along with whether there are any unintended changes to make it traceable. It can even help identify an obsolete document. Therefore, one best practice is to establish a standardized way to control the version process. You should be able to ensure the correct versions of all documented information are available at the point of use, and that well-marked older versions are kept apart from use. Whenever you review and approve a document, make sure any and all revisions are incorporated. There should be safeguards in place to prevent employees from incorrectly accessing and using

Speaker 3: obsolete information.

Speaker 1: Each organization is responsible for determining what documented information needs to be retained, the period of time during which it must be retained, and the media needed for its retention. The retention policy of documented information, paper or electronic, involving the quality management system, may differ among organizations. The documentation that supports the operations or processes, documented procedures, or records of evidence may also vary. It usually depends on the company's internal requirements, customer requirements, and legal or regulatory requirements. This position refers to what happens to the records after the retention times have elapsed. You can establish a policy that defines whether to archive, shred, or recycle the documents. Using an e-QMS solution that complies with 21 CFR Part 11 can reduce the effort needed to keep all of the above aspects in check, which can significantly impact the regulatory audit. As such, life sciences companies should consider moving from a paper-based QMS to an e-QMS for their quality records management. The most significant benefit is easier compliance, followed by better workflows, cost savings, easy retrieval, risk minimization, knowledge preservation, data protection, and higher employee morale. I hope this short course on document management helps your organization seamlessly build and

Speaker 3: follow better quality management practices.

Speaker 1: Document management best practices are for companies looking to streamline their document workflow and improve the efficiency of their employees. The following tips will help you manage and organize your documents. Continuous improvement initiatives using paper-based quality management systems are a hassle. Any change, big or small, takes more time than is acceptable. Furthermore, the storage space needed in a paper-based system is unsustainable and quite chaotic. An electronic QMS platform is a worthwhile investment for ensuring your system manages

Speaker 3: quality safely and efficiently.

Speaker 1: Before you define a hierarchical documentation structure in your QMS, you must understand the QMS pyramid model. Have a look at this short course. You will find there are five different levels. The quality policy, for example, is at the upper level. It defines the business functions and SOPs associated with each process. Each standard operating procedure may be a master document with the relevant workflow instructions. In this way, one document may be linked to another, as either a parent document or a

Speaker 3: child document.

Speaker 1: The standards and regulations applicable to your business are an important factor to consider before implementing a QMS. Companies in the life sciences industry can use ISO 9001, ISO 13485, EUMDR, GDPR, 21CFR Part 11, GXP, etc.

Speaker 3: These are some examples with specific requirements depending on the business goal.

Speaker 1: The use of manual processes to send documents, for example, the use of email or handing out printed documents, delays all documentation processes. Sometimes it also leads to lost information, potential miscommunication, or missed deadlines. On the other hand, a workflow built right into the document management system lets employees send documents, SOPs, deviations, CAPAs, etc. to the right people with a click of a button. This allows everyone to see what they need to work on. During the definition step of an electronic document management process, a clear definition of the main workflows is essential. Who will draft the documents? Who will review the different kinds of documents? Who will have the final authority to approve the documents? How will the documents be distributed? Who will have access to each type of document? How long will the documents be stored? How often will the documents be updated? What will the substituted document retention period be? Adopting an electronic QMS is an opportunity to streamline these processes and simplify or discard any manual tasks that don't add value. An electronic signature is a computer data compilation of any symbol or series of symbols that are executed, adopted, or authorized by an individual and intended to serve as the equivalent of handwritten signatures. The use of electronic signatures eliminates the risk of a document being changed, signed by an unauthorized person, or undersigned. Electronic signatures are legally binding and meet current security requirements, protecting your business from legal or compliance issues. For these reasons, I highly recommend the use of electronic signatures in all your documents. Assuming you want to move away from paper documents and filing cabinets, one best practice is to migrate your data to a cloud-based QMS. The cloud lets you share documents collaboratively and access them from anywhere and from any device. With a cloud-based QMS, you will not have to worry about leveraging a backup process to prevent data loss. Cloud storage gives you an added layer of protection in the event your stand-alone hardware gets damaged or stolen.

Speaker 3: You will still be able to access your documents in the cloud.

Speaker 1: Last, but not least, organizations will have higher employer satisfaction when they use user-friendly, attractive, and effective digital tools. Make sure the tools and interface of your electronic QMS are user-friendly and intuitive so that your team can easily use them. Learn how easily an eQMS can integrate into your existing operations for the following – document management, events, CAPAs, trainings, risk assessments, audits, etc. When making a change from paper to electronic, you must encourage the entire team to buy in and create efficiency in the document management process.