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Take the Document Control System Quiz (SPOILER: it’s pass/fail there’s no partial credit)

Take the Document Control System Quiz (SPOILER: it’s pass/fail there’s no partial credit)

How do you know your Document Control System is working properly within your medical device company? Take this quick Document Control Health Check-Up Questionnaire: Do you approve (via wet or electronic signature) documents prior to issue? If you use electronic signatures, have you thoroughly assessed their function for 21 CFR Part 11 compliance? Do your document changes go through an approved change control process? Are document changes reviewed by the same person or personnel within the same function who previously reviewed and approved the document? Are your changed documents formally approved again? Do you consistently issue unique revision numbers to documents according to established procedures? Do you consistently document a description of changes to documents according to established procedures?  Are approved documents available at point-of-use for affected personnel? Are documents of external origin identified and is their distribution controlled? Do you effectively prevent the use of obsolete documents? Are your documents backed up to ensure efficient retrieval in the event of disaster? Have you validated your document control process or your electronic document management system as appropriate? If you answered—without hesitation—“Yes!” to all these questions, you are in great shape. Congratulations! If you answered “No” or “Maybe”, or if you had to pause and really think about the answer, then you might need some assistance.   The amount of controlled content created by a medical device company is extensive.  Lack of document control can create regulatory risks, risks to your Intellectual Property, and erodes the value of your operations and assets. Don’t wait for an audit or adverse event to assess and improve your Document Control System. If you need...
Implement 21 CFR Part 820 Controls Early On

Implement 21 CFR Part 820 Controls Early On

Benefits and Risks of Moving to the Cloud Migrating to the Cloud: What are the Benefits? According to the National Institute of Standards and Technology, the cloud is “a model for enabling convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, servers, storage, applications, and services) that can be rapidly provisioned and released with minimal management effort or service provider interaction.” Most companies’ IT infrastructure use less than 30% of their capacity. It took years to get the capacity to where it is today, and it takes months to increase capacity. Employing qualified resources to maintain such an infrastructure is difficult and expensive. Cloud providers utilize about 65% of their capacity and can add capacity quickly. In short, cloud providers benefit from economies of scale, which enables them to lower individual usage costs and centralize infrastructure costs. Companies benefit by only paying for what they consume. Companies can increase or decrease their usage rapidly, and can spend less time managing complex IT resources. Not only do efficiency improvements reduce costs, the nature of some costs can change from being capital investment in hardware and infrastructure (CapEx) to a pay-as-you go (OpEx) model. Maximizing IT capacity utilization, improving IT flexibility and responsiveness, and minimizing cost are not the only advantages of the cloud. Collaboration can be one of the most important advantages of cloud computing. Multiple users, from around the world, can collaborate more easily on documents and projects. Because the information is hosted in the cloud, and not on individual computers, business owners can collaborate with external stakeholders in a secure environment with nothing...
21 CFR Part 820 Ensures Your Device is Safe and Effective

21 CFR Part 820 Ensures Your Device is Safe and Effective

An Early Practical Handle on 21 CFR Part 820 Improves Your Medical Device Business Operations The purpose of regulatory affairs is to ensure that your company complies with applicable laws and regulations. These regulations, such as Quality System Regulation 21 CFR Part 820, are intended to ensure devices entering the marketplace are safe and effective. What is the Quality System Regulation? FDA has identified in the Quality System (QS) regulation the essential elements that a quality system must embody, without prescribing specific ways to establish them. Because the QS regulation covers a broad spectrum of devices, production processes, etc., it allows some leeway for medical device manufacturers to determine the necessity for, or extent of, some quality elements and to develop and implement specific procedures tailored to their particular processes and devices. If you don’t fully understand 21 CFR Part 820 and how to apply it properly to your company, find a medical device regulatory consultant who does. Having experience in this area is critical to efficiently implementing compliance that supports your business goals. Quality System Regulation 21 CFR Part 820 focuses on current good manufacturing processes (cGMP) and controls used for the design, packaging, labeling, storage, installation and servicing for all finished devices intended for human use. You should know that 21 CFR Part 820: Is an FDA-mandated system of product design Requires you to document the evolution of the life of your product Applies a market-first product development focus Requires a team-oriented approach to product commercialization As a process, tends to challenge product design to the point of improvement Compliance is a necessary expense; don’t put yourself in a...