#rims system

[pleasepublish]

Using Excel sheets, registration trackers, ERP software to manage your global regulatory Health authority or notified body compliance activities. As a result, many teams end up using such software or Excels to manage their regulatory activities & thus putting companies, products & patients at risk.

Depending on Excels/ PLM/ERP?

Is your team still using Excel sheets, or other functional teams tools (such as registration trackers or ERP) to manage your global regulatory Health Authority / Notified Body compliance activities?

Learn why these tools pose either compliance or business risks if you manage your regulatory activities.

When it comes to tracking and managing your regulatory needs, Excel, PLM, and other general-purpose tools (like registration trackers) are readily available and your team already knows how to use them. In addition, as some of the commercial/Finance teams lack the comprehension on Compliance processes and corresponding potential risks, they tend to “suggest” using these “other” tools for Regulatory purposes also

As a result, many teams end up using such software (or Excels) to manage their regulatory activities and thereby putting companies, products and ultimately patients at risk

4 Risks in Relying on these Tools/Software to Track & Manage your Regulatory Activities:

Inaccurate regulatory information As these are all general-purpose tools, it is very hard to gather all regulatory information in a structured manner within a stipulated time. This often leads to incomplete information which leads to either overlook by teams or extra efforts to gather information from different sources

Improper Requirements & External teams Access Trackers created using Excel usually are stored on the author’s computer and are not accessible by other teams (locally & globally) in real-time. This makes it harder to share, validate, and track changes – frequently leading to incorrect requirements which may cause delays in regulatory submissions or answering notified body findings

Compliance Risks Most importantly – it is very easy for regulatory information to fall through the cracks when using Excel/PLM/ERP to manage them. Even critical information can be lost when the resource who is handling these sheets forget to update, or gets reassigned to other projects, or leaves an organization.

Technology Burden If companies create their own in-house systems for this, the tightly coupled integrations and the complexity that comes with it makes the upgrades very challenging when the business requirements change. With cloud based 3rd party tools, this risk is greatly mitigated.

What Should You Do Then?

So what causes such inefficiencies? The primary culprit is disconnected systems and data. According to a recent

Regulatory Information Management (RIM)

report from a leading research firm, a majority of organizations have a fragmented technology landscape with disparate tools and systems for identical-and related tasks. By recognizing the inherent problems using siloed systems, 2015 study reports that a growing number of companies are starting to employ global models.

A modern RIM tool that promotes global & external access, data harmonization and standardization, and has full data traceability and organization wide visibility should be the goal for any company to help them compete effectively and at the same time reduce compliance risks.

[pleasepublish]

Every day device manufacturers face challenges, especially if they have products in multiple countries. This can be from business needs or local demands or regulatory compliance that needs to be maintained for those countries. With limited resources (and time) it’s tough to track what’s needed and what’s the impact for product changes is tough and may lead to burnout of resources. Other bigger risk is when people leave, all the product activity, regulatory communications, and requirements are either gone or stuck in email boxes that will be very tough to pull them out meaningfully.

Other challenges include:

Manufacturers looking forward to expanding their scope globally often fall short to keep a track of the time and place of registrations, what’s due, when, and what document versions used in those dossiers.

The registration procedure is completely separate from the device data and hence keeping track of the both becomes difficult and this leads to never-ending excels after excels

The global changes in regulations are a continuous process and maintaining compliance is challenging as these country regulations may not be in English and increase your dependency on everything and anything.

When a change request comes in, to do impact analysis becomes a mini-project in itself gobbling a lot of Regulatory member time.

A proper Regulatory & Submission management tool can help minimize pain. A cloud-based intuitive system increases productivity and efficiency as well while maintaining proper compliance

Some Benefits of Regulatory system:

Revenue: Eliminates license renewals and other commitments date miss out risk. Also ensures minimize compliance issues that usually are a drain of internal time for audits, CAPAs, etc

Confidence & Strategy: Know exactly what product is what stage in what country accurately. This will help make companies make the right decisions with new products or life cycle changes as there will be constant changes from marketing and commercial teams on posing different scenarios and options frequently. Right information can help you give strategic inputs for different scenarios

Dossier builds: With proper Reg Intel built-in, a Reg data system ensures you get the right dossier checklists by country accurate and UpToDate all the time, This will lead to delays in HA/NB queries or rejections.

Regulatory source of truth: A proper system tries to bring together accurate information from various functional areas into one place. This tends to increase the efficiency of the organization as it can use accurate details without having to collect it repeatedly.

HA/NB formats: The same data goes to different countries in diff formats, not just the dossiers or tech files but going forward in digital formats of UDI in different countries coming up (EU, Australia, China). One tool to churn out these formats easily is a big help to teams to avoid mistakes and duplication.

If you want to explore what features will benefit you, please do a ViSU demo and decide if it’s a value or not to your company

[homebrewtalk]

Build A DIY RIMS System

I recently had a chance to brew with the professionals at a local brewery. They were brewing on a SABCO Brew-Magic (15 gallon) system that they use for their weekly small batch releases. The brewer explained the components and how they all worked together. The wort would circulate throughout the mash process and that the temperature would be kept constant by an electric heater that was in the circulation loop. And, the re-circulation helped with the efficiency and the clarity of the wort. The price tag for a system like this is way out of my price range, so buying one was not an option. It didn’t take long for me to start putting ideas together to build my own RIMS. My quest began to put something together that I could build cheaply and maybe upgrade over time. So, a low cost system (that was modular) is what I set out to build.

Editor’s Note: Hello everyone, this article was previously released and the author had used PVC piping for some of the heated elements of the system. After a lot of feedback on the issue, I made the decision to take the article down after potential safety issues were raised. I spoke with the writer and he agreed to upgrade the system he had originally built to use SS parts and re-write the article for the new build. So thank you to you the readers who spotted an issue, and a big thank you to Ted for upgrading and re-writing which took a lot of work.

There is already a bunch of nice, well thought out, designs out on the web. But, many were not cheap to build. The biggest expense was going to be the pump. I lucked out, I already had a 1200 GPH pump that I bought for a Koi pond and it wasn’t being used anymore. Yes, I cleaned the crap out of it, literally. Next, all those stainless steel pipes and fittings were $10-15+ each, times 10 or more. It was adding up fast. I originally chose PVC for a bunch of the parts. It was cheap, but after a lot of push back from reviewers about PVC temperature ratings, I replaced the PVC parts for the heat chamber with stainless steel parts. This increased the cost about $65. So, if you had to buy everything and did your shopping around, everything should cost under $350.

To clean the RIMS, I get a few gallons of PBW solution in a bottling bucket and connect it to the pump input and just pump it through the system and back up to the bucket. I let it run for about 20 minutes to a half hour. I’ll switch out the PBW with some sanitized to get it squeaky clean. The system works great. Nice clean beer and my efficiency is up about 5%.

Safety First

YOU MUST USE GFCI OUTLETS AND ALL ELECTRIC CONNECTIONS MUST BE GROUNDED!

This system is being used around water and hot wort. Accidents can and will happen. Don’t shortcut the safety of the electrical. If you don’t know how to do this, let some who does take care of the electrical work or save up and buy one.

Modular design I wanted to make my setup modular and compact. Something I could build into a portable carry case.

Temperature Use the temperature controller for more than just controlling re-circulation temperatures.

Pumping Use the pump for more than just re-circulation during mashing.

Power Project and electrical boxes for containing, controlling and switching things.

I set up my temperature controller with multiple switches to turn on and off the pump and heater. The power outputs from the controller box are wired to a standard A/C outlet within the covered box. So, the pump goes into the pump outlet and the heater goes into a heater outlet. I accomplished by breaking the hot power contact on the outlet and wiring them separately from the project box. Then, the switches will control whatever is plugged in to the outlets. This helps to keep the equipment modular. Now, I can plug in a heat wrap and control the temperature in a fermenter or pump water and moving wort between pots and to the fermenter using the switches on the project box.

Connections I went with hose clamp connections between the heating element and the pump (not in the pictures), so they can be disconnected fairly easily. These will eventually be upgraded with some quick disconnects to make it even faster.

Temperature I did not want to hard connect the temperature sensor to the heating chamber or the load on the heating element. By setting it up this way, I am able to plug in whatever load I wanted and mover the temperature probe to wherever I needed it. For example, I can use the temperature controller for my heater wrap to control fermenter temperatures or just move the probe to measure temperature of grain, cooling wort, liquid in a hot liquor tank, etc.

The liquid from the mash tun will come down into the pump on the right. The flow can be controlled with the valve before it enters the heating chamber on the left, where it is heated and forced back up to the mash tun.

Parts List

1   Hose Fitting, Adapter, 3/4″ NPT Male x 1/2″ Barbed

1   Ball Valve Full Port 304 Stainless Steel w/Blue Vinyl Handle 2PC 2-PC

3   AC 110-120V 3 Pin I/O Control SPST Rocker Switch

2   Hose Fitting, Adapter, 1/2″ NPT Male x 3/8″ Barbed

1   White Silicone Tubing, 3/8″ID, 1/2″OD, 1/16″ Wall, 10′ Length (I’d recommend using ½ inch ID to go back to the tun, it won’t kink as easily.)

1   5500W 240V Screw-In Foldback Water Heater Element – High Watt Density

1   2-1/2″ Thermowell Stainless Steel 304 – 1/2″ Male x 1/2″ Female

1   Hammond 1591ESBK ABS Project Box Black

1   Inkbird All-Purpose Digital Temperature Controller Thermostat w Sensor 2 Relays1 1/4″

1    1 1/4″ X 8″ Stainless Steel Pipe

2   1 1/4″  Stainless Steel T

3   1 1/4″ X 1/2″ Stainless bushing

1   1 1/4″ X 1″ Stainless bushing

1   2 gang outdoor outlet box for GFI

1   GFI outlet

1  Standard Outlet

2   Outdoor A/C extension cords

Basic Build Steps

1. Build a Base

I built a base out of some scrap wood. It is basically an “L” shape, with parts connected to it for stability and transport, and a box to hold pump. The dimensions will probably be different for yours, depending on size of the pump. My base dimensions: 18” long x 8” high x 7” deep

2. Build the Heat Chamber and Connect the Pump

2a. Upper Tee Assembly: Assembled the following parts using Teflon tape to complete the upper tee assembly.

1 1/4” Stainless Tee

1 1/4”x 8” Pipe

2b. Hose End Adapters:

1 1/4″ Male X 1/2″ adapter

Hose Fitting Adapter, 1/2″ NPT – Male x 1/2″ Barbed

2c. Temp Sensor and Adapters:

1 1/4″ Male X 1/2″ adapter

2-1/2″ Thermowell SS – 1/2″ – Male x 1/2″ Female

2d. Lower Tee Assembly

The heating element will thread through the outlet cover and into the 1″ reducer in the Tee. Use Teflon tape or pipe joint compound to seal it! It is super important that this does not leak!!! You don’t want liquid getting into you electrical box.

Assembled the following parts using Teflon tape to complete the lower tee assembly:

1 1/4″ Stainless Tee

2e. Hose End Adapters1

1/4″ Male X 1/2″ adapter

Hose Fitting Adapter, 1/2″ NPT Male x 1/2″ Barbed

2f. Outlet Box and Adapters

Single gang plastic outlet box

Outlet cover with a 1.3” hole drilled in the center

1 1/4″ Male X 1″ adaptor

5500W 240V Screw-In Foldback Water Heater Element – High Watt Density

Wire one end of a section of electrical cord to the heating element terminals and the other end to outlet box that will connect to your heater switch.

3. Complete the Heating Chamber

3a. Screw the two tee assemblies together.

3b.  Screw the electric box to your base.

4. Attach the pump

I made a little housing for my pump. I will just pop out of its home for when I want to move it to another task.

4a. Attach valve and hose adapter to the pump output.

4b. Connect with a short hose to the heat chamber.

4c. Attach hose adapter and hose to pump input. This will connect to you mash tun.

5. Build the Heat Controller Box and Connect

5a. Make the Control Box and mount it to your base

5b. Cut holes for your switches and controller.

5c. Drill holes and insert rubber grommets to accept power cord input and output feeds.

5d. Install switches and controller into the case

6. Wire your RIMS up

6a. Black power lead and white neutral to pins 1 and 2 to power the controller.

6b. Black power lead to each switch inputs.

6c. Output of pump switch goes to the pump

6d. Output of heater switch to heat connect pin 5

6e. Output on pin 6 goes to the heater

6f. The neutral leads (white) get connected together and pair with the power lead outputs to go to the pump and heater outlets.

6g. Connect temperature sensor to pins 3 and 4.

I wired my heater and pump outputs to the electrical box. One socket for the heater. One socket for the pump. The pump and the heater can then plug into their proper outlet. I did this to make it more modular.

Build A DIY RIMS System was originally published on HomeBrewTalk.com