Source: https://www.orcanos.com/compliance/category/21-cfr-part-11/
Timestamp: 2019-08-24 04:15:51
Document Index: 151561087

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21 CFR Part 11 Archives - orcanos
Posts in 21 CFR Part 11
Tip Of The Week – Common Faults A Document Controller Can Avoid
September 11th, 2017 Posted by Rami.Azulay 21 CFR Part 11, Collaboration, Document control, FDA, ISO 13485, Standards and Regulations, Tip Of The Week 0 thoughts on “Tip Of The Week – Common Faults A Document Controller Can Avoid”
Common Faults A Document Controller Can Avoid During The Document Control Process and Their Mitigation
Whether you are a medical device vendor or function in another regulated field, the document control process is an essential part of successfully launching a product. You have the option of using an archaic filing system riddled with a minefield of human errors, or an automated electronic system. So if you are at the point where you are under a significant workload, and wish to have better compliance with the regulatory authorities, such as FDA, CE, it is time to consider an electronic document control management system, an e-DMS (Electronic Document Management System).
ISO 13485 section 4.2, describes the requirements which must be adhered to when producing documentation. Such documentation includes quality management manuals, procedures for approval, distribution, and change of a document and the designation of a person or persons who should implement those procedures. In the ISO13485 2016 edition, specific procedures outline the prevention on of record loss, as printed documents filed using a traditional system, are at high risk of being lost. 21 CFR Part 820, is an essential regulation not only for medical device firms but for the food and pharma industry. For both, document control is an imperative.
The ISO13485 2016 edition (sections 3.2, 3.10, 6.2, etc.) is indicating both individual and corporate how to route documents in your document management system, for example, the following routing phases: document creation(draft), approval, rejection, change control, retrieval, and obsolescence.
According to FDA statistics, document control errors are frequent and numerous. Clinical trials indicate that many documents routed and logged, are inadequately documented and contain inaccurate case histories. These deficiencies make up the second most commonly cited FDA problems, and they rank fifth by the European Medicines Agency (EMA). In warning letters and audit observations, it was discovered that inadequate documentation impacted the thoroughness and level of care physicians can offer patients. Poor document management is the direct result of paper documents, that can be easily misplaced.
In this article, I will discuss common issues which arise in every phase of the life cycle of a document. The information I will share comes out of my 25 years of experience developing ORCANOS Medical e-QMS (Electronic Quality Management System) software solutions for regulated companies, as well as my direct involvement in the implementation and deployment of ORCANOS Medical solution by quality professionals who are responsible for document control and quality management.
The 5 Routing States of the Document Control Process
Stage 1: Document Draft Creation
Problem #1: Collaboration is time-consuming.
Rarely one person is generating the document person, and almost always get approved and cycled over several stakeholders. Collaboration is normative during the initial phase of creating a document. This activity is time-consuming and can be rather costly. Bringing all stakeholders together in one room can also be impractical, as relevant individuals are rarely in the same place at the same time. Additionally, the traditional method of routing a document via email is increasing the chance of conflicting edits.
Collaborative tools, such as Google Docs is an excellent way to cover some of the issues local office documents introduce. However, while Google Docs collaborators have the convenience of working together online, it does not resolve the critical obstacle of traceability. This approach requires extra work to approve and distribute these documents.
Our Suggestion for Collaboration
A Cloud-based document control system creates a virtual collaboration workspace. The workspace allows team members to add their files in a secure and real-time environment anywhere, anytime. The workspace gives global access to every employee, to add his/her document without having to wait for someone else to unlock the document. A cloud-based system not only allows access to authorized users 24 hours a day, but also eliminates the constraint of being in the physical location of the file, improves search capabilities and reporting, and allows Metadata definition for each file. DropBox, Google Drive or any other file sharing system are not supporting these capabilities.
ORCANOS e-DMS provides lot of capabilities, subjected to user privileges.
Stage 2: Document Routing Process Approval and Distribution
Problem #2: Availability of personnel delays and grinds productivity to a halt.
People are not available. The process might involve executives who travel a lot. In the world of paper-based or hybrid process, there is a challenge to control or escalate a case where the approver missed its target. With an electronic system, you may have an alternate signer, who is authorized to replace the original signer (according to SOP). Also, such a system ensures that approvers do not misplace the right cell to sign on a printed document.
ORCANOS e–DMS puts a due date for each document to sign, and fire an alert when the time is due.
Problem #3: Misuse of revisions that are an obsolete revision.
The control on old document revisions is still a major challenge to QC and others departments. Once a new revision becomes effective, accessing older revision (which is now obsolete) should be forbidden, leaving only the last approved revision available for download. Using the obsolete revision of a procedure, drawing or specification is still the source of many errors. Lack of access to released documents, as well as difficulty in finding them, is often the result of staff making uncontrolled copies, either paper or electronic.
Problem #4: Training can fall through the cracks.
The cycle of approval of a quality document ends with distribution. There is a major challenge in notifying relevant stakeholders.
In such cases, it is needful to create traceability from the approved documents to training forms. Such training form needs to have a life cycle of its own, but it will be clear what action needs to take place in order to make the document effective.
ORCANOS e-Training module allows you to create these links easily. So for example, if new working instructions need to be deployed the working instruction documents must first be approved. You will next need to create a training form which specifies the audience who needs to participate in the training of the new working instructions and trace it back to the released document. As quality personnel, you will have all the information in one place, a system that will also notify when the training has completed. Ensuring that the appropriate people understand the change and are competent to perform the newly revised work instructions can be challenging for many organizations.
Our Suggestion for Mitigation:
In our 12 years of experience, we have found that companies reduce their review and approval turnaround time significantly after implementing ORCANOS e-DMS process. Routing, follow-up, escalation, and distribution are all automatic, saving time and effort. Usually, companies run into trouble to manage such copies of the old revisions. The distribution of new revisions has also become time-consuming, requiring control and follow-ups. Using electronic system brings the ability to control your document copies and tracking of will solve great problem controlling your documents. The integration of document control with your learning management system ensures that training tasks related to document changes will not fall through the cracks.
Stage 3: Review/Reject and Change Control
Problem #5: Neglecting review during document cycling.
As a Document Controller, you need to follow the document review procedure which is used to review and ensure that a document’s content is applicable and accurate based on current project objectives. In many cases, processes evolve without the documentation being updated, so changes done in the document are not fully reflected. ORCANOS e-DMS system is helping to implement the standard operating procedure and ensure that the actual process and documentation process are in sync.
Problem #6: Who needs to review what and when, is a big challenge.
Each document requires a different set of people to review it. Ensuring that each change is well documented and executed correctly, requires that the right people are involved in the change control process. Having too many people involved does slow down the process and reduce efficiency. At the same time, overlooking an individual or group during a change can result in issues down the line. So if for example, we perform engineering changes by the R&D group, it may be acceptable to the regulatory and quality team, but not passed by the manufacturing team, who may need to adjust their tools/jig to adopt the changes.
Problem #7: Product iteration information is largely based on “tribal knowledge.”
Knowledge preservation or knowledge transfer is always a risk. The complexity of some of the products as well the regulated path it needs to go through may take several years. So it is reasonable to think that at some point in time some of the people in the original design team might have been assigned to other business units or have left the company. In a manual process, you will need to collect paper documentation from remote resources. Some of them may be on someone’s local PC or spread over email inboxes, so product history becomes not handy and overburden understanding the product evolution.
Any developing industry using ALM tools will utilize iterations. Most commonly used methodologies such as Agile Scrum, DevOps or even traditional Waterfall are based on release and lifecycle of development reflected by their versioning number. Such iterations are used both before and after the product is released to the market, which makes change management crucial. Since requirements, test and all other types of changes are described by documents, we need to control every change. With an electronic system, you can control singular changes in the level of requirements, and route it based on relevancy to different groups of people. This will cause the change control process to be both efficient and thorough. Additionally, having a centralized repository for all product documents provides the ability to create traceability between documents, so when one is changed you can easily discover the impacts on others. Cloud-based systems also allow easy reference to the relevant documentation even long after a product has been launched. Having an electronic system also gives the organization the advantage of performing basic tasks such as e-signatures which comply with CFR 21 Part 11, Implementation of ISO 13485 Sec. 4.2 completely, timing and scheduling reviews, dynamically collect the relevant people for review and automating the distribution of approved documents.
Problem #8: Searching a document
The need to reference a document arises in several cases such as daily use, internal audit, external auditor during any quality event. The ability to retrieve such documents efficiently is part of what today’s organizations are measuring up to. A common challenge among organizations is the investing of significant effort finding documents when they are needed. Using traditional paper documents in filing cabinets or electronic versions on file shares increases the risk of not being able to do intelligent searches. You want users to be able to search for documents and find them quickly.
Many people are accustomed to searching for information by simply typing in the terms they are searching for, getting the desired results. In some cases, it is more efficient for users to find the documents they are looking for by browsing an organized hierarchical structure. It is important to support both search and browse approaches to finding records. In either case, associating the proper metadata to the document, as well as supporting full-text searching are critical. The system should enable your organization to find the needle in the haystack quickly.
Problem #9: Misuse of documents that are obsolete.
Part of a regulated company’s day to day task is to maintain document archives, stored for historical purposes, as well as to avoid misuse. It is important to keep documents for as long as they are effective. The effective date of some documents may expire, and you need to renew them. It is not enough to only control the approval process, but the lifespan of a document must be determined. The document shall not be deleted by the concept but being blocked from mistaken use. Over time, the collection of documents can be overwhelming and clutter your quality systems, making searching more difficult.
Problem #10: ECO release of documents timing cause great effort.
Part of the change control procedure is the ECO release. The ECO form may include a set of documents to be released, and also reflects the changes in the revision of each document showing the newly approved version, as well the obsolete document. Using traditional methods requires close observation and control of each document through the logging of changes. Human errors and fault are common in such heavy ECO releases and can cause misleading distributed documents.
Companies standard practice is to archived documents up to 15 years. There may be issues with keeping records longer than that period. Regulatory requirements usually dictate a company’s retention time frames. The time frame a document remains available becomes a RISK to meet the minimum regulatory requirements. An electronic system is ensuring that the access to approved documents or obsolete is well controlled. Storage today has become a neglected issue by most IT department.
So what do you need to do, to avoid the problems above?
If you are using paper-based or hybrid processes, making a move to a fully automated system will improve your quality management significantly. If management of your documents is your most pressing problem, it is time for you to find an out-of-the-box tool that fits your needs. The available features as well as the complexity, and the amount of effort required to set up a system must all be taken into consideration when deciding on an electronic system.
Document Management Software Tool Selection
As you consider which document management software to select, or QMS, ensure the DMS covers other areas of your product lifecycle for example ALM (Design Control). The ALM part covers the R&D phase and the traceability to the design and validation documents, as well as to the traceability between different requirements in the V&V paradigm. ORCANOS | Medical solution is a one of a kind product that enables you to manage both R&D and Quality Management in one place, such as RISK management (ISO 14971) and Complaint Management (ISO 13485 Sec. 4.2) which are an integral part of any Quality Management System.
ORCANOS Platform contains all core applications, allowing access to an integrated quality management suite with the unlimited ability to create new modules and tools (BOM, ECO, CAPA, Training, Printing Labeling, Manufacturing with e-DHR and more) that you can use as needed. ORCANOS e-DMS systems can be used as a starting point solution, but also as the foundation of a quality management system. It is scalable, configurable, and there is room for adding more solutions and addressing future quality needs. ORCANOS is a leading vendor and pioneer introducing such integrated platform.
In regulated environments, document control is the sound basis of quality. It is not a stand-alone system; it has branches and links to other procedures and processes that directly/indirectly affect product quality and safety. The control of all relevant documents (and the process for changing those documents) is a highly complex management task. Automating your manual or hybrid processes will significantly increase your organization’s efficiency, accelerate time to market, help maintain compliance, and reduce your overall compliance costs.
Orcanos document Management System
Orcanos Quality Management System
Tip of The Week – How You Can Be The Best Recall Specialist
April 26th, 2017 Posted by Rami.Azulay 21 CFR Part 11, ISO 13485, Recall, Services, Tip Of The Week 0 thoughts on “Tip of The Week – How You Can Be The Best Recall Specialist”
Recall Specialist – Medical Devices
Author: Rami Azulay (ALM/Medical Specialist at ORCANOS)
Are you eager to join an innovative organisation? Do you want to play an integral role helping clinicians improve healthcare outcomes for patients? Have you always wanted to join a driven, entrepreneurial organisation that promotes from within? Then your ideal role is that of a Recall Specialist!
As a Recall Specialist, you will be required to provide Product Field Action, which means you will given direct access to all product design documents and verification, and validation protocols in order to perform effective investigations. You will need access to both production and manufacturing evidence documents on the device performance during production and methods which support the QC process. You will need access to the reporting entity so as to be able to collect missing information needed to execute your CAPA process and of course, access to the support groups on Tier 1, 2, 3 and 4. These tiers support and manage a diverse range of medical devices. These tasks are only able to be carried out through a collaborative working environment; not just in the human resource level, but also between the tools and repositories that hold that information.
The key duties of the recall specialist include: The regular reporting, follow-up and processing of regulatory actions, which require more time outside of your day to day tasks. While tools such as ORCANOS | MEDICAL system can provide you with proactive notifications based on Artificial Intelligence (AI) built into the system that compare your execution activity with the regulation and compliance to your organization standard operational procedure (SOP). This will involve actioning on all aspects of Product Hold (PH) and Product Field Actions (PFA), and enacting the Universal Recall Procedure (Post Market Surveillance) to ensure the appropriate maintenance or removal of nonconforming products from the marketplace. Again ORCANOS | MEDICAL includes with the same system a Post Market Surveillance system call ORCANOS | SERVICE CENTER which act as gateway between the market to the manufacture or the distributor. It allows secured data communication between all parties, of course the AI system will cover regular reporting and follow up on actions, on that same system as well.
It is preferred that the Recall Specialist hold a tertiary science/engineering degree or equivalent. Such academic knowledge coupled with access to relevant and accurate information adds to the effectiveness of the Recall Specialist. ORCANOS Cloud based system, which is validated and 21 CRF Part 11 compliant, makes the world a much smaller place. Information that is needed is easily accessible from anywhere – either from the event area (if you need to travel for investigation), or from your office where you communicate with other professionals, and information needs to be secured as you work on a quality event.
Having a single tool that can manage all these activities R&D->Quality->Manufacturing->Support in one place, reduces lessens the learning curve for the recall specialist who has to be acquainted with multiple systems, reduces the cost of licensing which enables access to secured information needed to work efficiently. .
This role provides an exciting opportunity acting in the center of all things, using advanced tools and methods that can guide and protect the organization interest which will follow by constant recognition for creating a positive workplace environment. If you are looking to take your career within QA and post market to the next level this could a sure way to go.
Tags: Medical Device, Post Marketing, Recall
Working with Orcanos DMS (Document Control) and Dropbox
June 2nd, 2015 Posted by Rami.Azulay 21 CFR Part 11, Document control, FDA, ISO 13485 0 thoughts on “Working with Orcanos DMS (Document Control) and Dropbox”
This article is targeted for medical device manufacturers SMB’s working with Dropbox as their main collaborative environment for document sharing. It describes the process of working with Orcanos Medical and Dropbox.
ORCANOS DMS BENEFITS
Import your existing QMS files and folders in one click
Part 11 compliant, automatic revisions control.
Obsolete documents – Assures that users don’t use obsolete revisions – Orcanos adds watermark “Obsolete” when a new revision of a document is added along with an effective date
Sign documents electronically, directly from your email, next singers are routed automatically
Ability to export entire DHF to file system with one click
Publish documents to PDF upon approval, and attach a cover letter
Organize documents hierarchically, and allow to share a document on different locations
No revisions control (A, B, C…)
No option to electronically sign documents, including routing process definitions, etc.
Not part 11 complaint
Each document has multiple instances per revision, for example, FMEA_A_1.docx, FMEA_A_2.docx, FMEA_b_1.docx. The Quality control manager needs to save an instance of the document after every change he wishes to publish, manually
Hard to share all last approved documents, for example. This has some risks, as a user can work on an obsolete version of the document, without knowing there is a new version
Signing a document is done in the old “Classic” way of printing the document and sign with a pen.
Managing the routing process manually, while the organization is spread over the globe makes it harder to finish an approval process on time.
A cover letter is manually built.
WORKING WITH ORCANOS DMS AND DROPBOX
Signatures and revision management and control are done in QPack DMS
Establish a new tree structure with last revision of the document (or last edition of not approved)
Clean document name format, so instead of FMEA_A_2_approved.docx, make it FMEA.docx
Import entire tree to Orcanos DMS
All documents will get revision A.1 automatically
Sign documents on Orcanos
Now export DMS content using Orcanos DMS Export for released revisions. Note that approved files of type WORD will be downloaded as PDF
Share this tree in Dropbox
Configure the Dropbox sharing options
QA will refer to Orcanos DMS only
Users keep working on Dropbox
Whenever file needs to go through a signing process – it is uploaded to Orcanos and get controlled by Orcanos
Do I need a full validation of QPack, or is Orcanos COC is enough?
November 11th, 2014 Posted by Rami.Azulay 21 CFR Part 11, 510(k), CE Marking, Notified Bodies, Pre Market Approval (PMA), QPack Validation 0 thoughts on “Do I need a full validation of QPack, or is Orcanos COC is enough?”
What is COC: Type Approval or Certificate of Conformity is granted to a product that meets a minimum set of regulatory, technical and safety requirements.
Orcanos provides this certification for its customers, but the question whether its instead of QPack validation, well, in some places it is enough, for example in Europe (CE), and in some places its not, such as in US, FDA, where the medical device manufacturer must do a full validation of any IT software he uses, based on the intended use.
You need to check with your regulatory consultant about it.
Medical Device Regulatories (USA/Europe)
February 23rd, 2011 Posted by Rami.Azulay 21 CFR Part 11, 21 CFR part 820, CE Marking, FDA, Medical Device Directive 93/42/EEC 0 thoughts on “Medical Device Regulatories (USA/Europe)”
FDA ( Food and Drug Administration)
Required in the United States, the regulations used are CFR 21 Part 11 (CFR=Code of Federal Regulations), Electronic Records and Electronic Signatures, and 21 CFR Part 820 Quality System Regulations (QSR), outlines Current Good Manufacturing Practice CGMP regulations that govern the methods which must apply to the development of software that acts as a component of a medical device. Companies who comply with the PMA FDA regulations recieve the FDA Approval.
Companies who comply with the 510(k) clearance are 510(k) cleared, but not FDA Approved.
MDD – European Medical Device Directive 93/42/EEC
European standard for risk protection associated with the design, manufacturing and packaging of medical devices. Compliance with the requirements of the MDD is declared by placing the CE marking on the product, which supply the device with a comfofmity decleration