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Thank you! I can see how process characterization would be a great addition! I will have to think about how and when to do it. :)

Hi Naeel, To validate electron signatures, you will need to define various software requirements for the electronic signatures. Examples unique user id and password combination, date and time stamping, etc. After the requirements are defined then you will create the software or purchase the software. Once the software is in place (installed in an installation qualification) you will challenge the electronic signatures by developing test cases that will be executed during the operations qualification. I know this sounds complicated. 21 CFR part 11 has some detailed requirements for electric signatures. You can use it to help defined your software requirements for the electronic signatures. If you purchase the software from someone else, you can leverage their testing documentation if they validated the electronic signatures. I hope that helps. Sincerely, A-A-Ron

No, they do not have to be in the Medical Device File (MDF). They need to be in the Design and Development File as they are the records that show you met the requirements of ISO 7.3.6 Design Verification and 7.3.7 Design Validation.

Thank you for the positive feedback! :)

Just keep this in mind. A process validation contains multiple separate qualifications that focus on different elements of the process. ;) A complete standard process validation consists of three separate qualifications. IQ, OQ, PQ. So, if you are talking about multiple qualifications, then it’s a validation. If you are talking about just one or two qualifications. That’s all it is, a qualification, not a process validation. 😊

I am not sure. Its not impossible. Good luck! :)

Thank you Sir!

Well, doing an SAT requires time to develop the protocols and then to execute them. So, yes, doing an SAT will add cost up front. The reason you do an SAT is to identify problems with the equipment before it leaves the equipment manufacturers’ site, so they can fix it before shipping it to your site. Doing the SAT will help prevent larger delays later if problems are found once the equipment arrives at your site. Think of it this way, if you find problems with the equipment once it’s at your site, how difficult is it to get the equipment manufacturer to fix them? If you identify the problem while it’s still at the suppliers site, they have a tons of motivation to get them fixed so they can ship the equipment to you and get paid. ;)

I do not know of a good definition of customer property in the ISO documentation family as it is not in ISO 9000. I recommend looking at the FDA pre-amble for the new QMSR, specifcally comment 26. This is the text. :) "(Response) FDA agrees with these comments and has adopted for the final QMSR the definitions set forth in ISO 9000, including the terms “customer,” “nonconformity,” and “verification.” With respect to the definition for “customer,” we note that when considering the requirements related to customer property in Clause 7.5.10, manufacturers must comply with this provision to the extent necessary to assure the safety and effectiveness of the devices being manufactured, consistent with the requirements of section 520(f) of the FD&C Act. For example, a manufacturer is expected to ensure that the integrity of a component provided by a contract manufacturer is not compromised before it is incorporated into the device being manufactured. To the extent any customer property requirements may be interpreted to go beyond the safety and effectiveness of the devices being manufactured, FDA does not intend to enforce this provision for such activities."

Thank you Sir for the great feedback!

Yes, the management representative can be sourced to a consultant. Just keep in mind if this is done, the consultant will need to meet the requirements for the management rep listed in ISO 5.5.2. :)

Yes, this is done in very small companies. Just keep in mind the definitions for each role and ensure the person meets the requirements for both. ;)

Unfortunately, I would have to research this topic more to answer your question. You will need to find an expert in sterilization validation to get the best answer. :)

Examples? Can you clarify?

Thank you for the Feedback! :)

I am happy you found it helpful! :)

Thank you for the comment and feedback! I means a lot. :)

Thank you for the suggestion! The questions are difficult to answer directly because they require knowledge of the company specific process. :) They are intended to make you curious about your companies processes so you can find the answers as they relate to your company. Best of luck!

The approves of the design transfer plan will be defined in your design controls procedure or the document control procedure. As the number of approves increases, its sign of excess complexity in your process and does not normally improve the plan. :) Minimum, you want quality assurance and operations to approve the plan. Other groups can be included as needed. :)

Hi well explained thanks for the video could you answer whether the design plan can be approved if not all the points in checklist is closed?

Thank you Diana! I am very happy the information in the video helped you with your audit. :)

Thank you for the comment and feedback! :)

Thank you for the comment and feedback! I am happy you found it helpful!

I am happy you found it helpful! :)

HIPPA compliance normally only touches traceability, complaints, and recalls. You question did make me think about a IVD tester that could be sent back for servicing. In that case you would have customer property that may have patient identifiable information in it. If that is the case, your procedures would need to define controls for protecting that information and ensure your controls meet the requirements of HIPPA. Let me know if that helps. :)

FDA = US Food and Drug Administration

Thank you for the feedback!

I am happy you found it helpful!

Thank You!

Thank you John! I hope you are well and enjoying life! :)

Hi TheGeorgeForce, During the management review meeting you will be reviewing both product and process performance. When the performance does not meet expectations, action must be taken. There are different actions that can be issued during management review. They are actions that are tracked in Management Review and then actions opened in other quality sytems, say the CAPA system. Comment management review actions are: • Wait and see • Review the area and report back to management • Investigate the issue and determine the need for a Corrective Action • Open a Corrective Action or Preventive Action I hope that helps. :) Let me know if its confusing. Sincerely, Aaron

Thank you for the feedback! I'm happy you liked the information. :)

Hi pv6765, No, its ok to have only electronic documents if that’s how your system is defined and validated. This is really up to your company to define how the QMS and its documents will be managed. Sincerely, Aaron

Hi pv6765, No necessarily. If they are all the same except the sizes, then they likely share 95 - 99% of the same documentation. You would then have to clearly define how the different product sizes are determined in some specification which allows for either different component numbers and inspection criteria. The DMR would need to be able to cover 32 finished goods. That means once you have the DMR, you could build any of the 32 codes it covers. I hope that helps. 😊 Sincerely, Aaron

@@QualitySystemsExplained Thanks, Aaron! Very helpful.

Most welcome

Thank you Vikas! I hope you are well! :)

Hi Paul, Great feedback! Right now I am in the middle of a big series of videos on pharma cGMPS. I cannot promise I will create something good and I will put some thought into the “How to” question. Maybe I can develop something simple that I can present in under 3 minutes. 😊 Thank you for commenting. Sincerely, Aaron

Hello Guillen, I have no experience with registration and listing for food companies covered by FDA regulations. Which markets (globally) does your client want to export to? I was able to find this step-by-step guide. Does it help? www.fda.gov/food/online-registration-food-facilities/food-facility-registration-user-guide-step-step-instructions-registration Sincerely, Aaron

You're welcome

Hi Anna, Thank you! I'm very happy you found the videos helpful. Sincerely, Aaron

Hi SingPray, The easiest way to explain this is the following: • For the IQ you must have a protocol and a report. • Fort the OQ you must have a protocol and a report. • For the PQ you must have a protocol and a report. You can combine those or keep them separate. Its totally up to the company to decide how they want to do it. In your explanation it appears that the Master Validation Plan contains all the protocols and the reports. It also sees you combine protocols for OQ and PQ. That’s fine as long as the protocols are pre-approved and the summary reports are written after the protocols are executed. The way your company uses Master Validation plan is a bit different that what I normally see, although I have seen company doing what you are doing. 😉 Just try to keep in simple. Protocol = Plan and Report = Results. Your plans have to be approved before you execute. Once you execute, you then summarize the results in a report. Let me know if this helps. 😊 Sincerely, Aaron

@@QualitySystemsExplained you are the absolute best! I wound up looking up FDA guidances on this and it made total sense. Pretty much it described what your just said. So I completed my protocol for an equipment validation and waiting for the approval on it before I start my report. Thanks again! It finally clicked lol. I could have asked my manager but some managers are very defensive thinking I’m questioning them rather than having questions. Again your videos are a life saver.

Hi Hassam, If you go by the regulation the correct way is “Design History File”. For 13485 its “Design and Development File. When it comes to industry, you are correct, they are interchangeable because many people (including me) say “Device History File” by mistake when they are referring to “Design History File”. I know I have been using them interchangeably for years until recently when a fellow AAMI faculty told me I said it wrong a couple times. 😉 Either way, people will know what you are saying. Sincerely, Aaron

Thank you Kyle! :)

Glad you liked it! Send me any question you have and I will try to answer them. :)

Glad it was helpful!

Hi SP, The answers are specific to the quality system at your company. If your company does not have a quality system, then its difficult to say. Both 820 and 13485 define the minimum requirements for Quality Management Systems. I hope that helps. If you have any other questions please send them along. :) Sincerely, Aaron

Hi Mansi, The answer depends on your status with the FDA. If you are a manufacturer, then yes, you would need to complete the process validations according to your quality management system. If you are not considered a manufacturer and are only manufacturing components for your customer (a medical device manufacturer); It will depend on your customers requirements that they must define and communicate to you. If they require process validation, then yes, you would need to meet that requirement. If they do not, then its up to you to decide what’s best for your business according to your quality management systems requirements. Sincerely, Aaron

Most welcome!

Thank you Pouria!

Hi Manish, You have asked me to answer bonus question 3. Here it is. Bonus Question 3 - How do we capture the intended use and user requirements for the device? This is company dependent. Most companies will have a Design Input Document (DID), User Requirements Specification (URS), or a Product Requirements Specification (PRS). It does not matter what it called. Bottom line is that your device will either be novel and brand new or will address the same intended use as a currently marketed device. This gets into regulatory pathways some and I will not cover that here. Basically, in the requirements document (DID, PRS, or URS) there will be a marketing section and a regulatory affairs section. In both of these two sections the design team will have to define the intended use and the indications for use. This will be part of the design foundation. I hope that helps. Sincerely, Aaron

@@QualitySystemsExplained Thanks Aaron