FREQUENTLY ASKED QUESTIONS

No. Our systems are extremely easy to setup and use. With our hands on training, and step-by-step manual, individuals with basic knowledge of computers will be able to setup and manage this system.

As the software is applicable to multiple different types of environments and levels of regulatory requirements, the time required varies. For less regulated usage, the system could be in use within a few days. For more regulated usage, such as Pharmaceutical Manufacturing applications, the average implementation time is 3 to 5 months. The additional time is normally a result of the Change Control process, including all assessments, procedure creation requirements, validation, and training.

Yes. Every action down to the individual button click is tracked and logged. Audit trails can be obtained for any person, process, asset, room or area, product, etc., within seconds. These results can also be filtered to maintain client NDAs or exported as PDFs or Excel files for secondary usage.

As a general rule, the challenge with integration is rarely limited by ARCBook or any ARCSystem product. We can do full integration, where data is shared between two systems, or database review integration, where a data pull is put into a secondary database that is only looked at to keep each system updated/informed.

ARCBook has robust control options to notify employees if a piece of equipment is not cleaned, not released, not calibrated, not standardized, or can include other rate-limiting risks associated with your site specifically. This includes blocking the employee from selecting equipment from being used and informing them of the required action, visual identifiers at the top of each room’s dashboard to show what actions are required for continued processing, and time-based alerts to inform employees if a piece of equipment is about to “expire” for one reason or another. Additionally, if activities such as standardization for a scale are input with out of specification results, the system will continue to block usage of that asset.

 With our off-the-shelf system, over 99.7% of all logbooks that are required at a site can be constructed. If your site has a unique logbook that requires a different feature than is currently in the released version of ARCBook, we have a team of software developers who can work to implement the required feature. The average time for custom requirements is 5 business days. We’ll work directly with your compliance, quality, or validation groups to ensure that any code updates meet the GAMP 5 and local site requirements to minimize impact to your operations.

The data from ARCBook can be stored on a locally maintained server or to a cloud-based solution. The standard practice is to store the cloud, in duplicate, on two Microsoft Azure servers that are in two different areas relative to the site using the software. This redundancy reduces the likelihood of outage and ensures data integrity can be maintained.

Our average software up-time is greater than 99.99%. This rate is based upon nearly a decade of software usage across dozens of locations. While outages can occur, they are almost always a result of your local internet provider rather than ARCbook itself.

Once an entry has been made, that entry cannot be removed. In the event of an erroneous entry, the entry may be edited; however, the edit must be approved prior to occurrence and approved prior to acceptance. This means that if an entry is made and needs to be changed, the correct level of oversight is built into ARCBook to ensure compliance and business continuity.

Like most industrial / manufacturing solutions, the cost can vary, and we suggest you obtain an actual quote from us; however, the average cost is between $40 – $ 60 per user, per month. There are maximum charge amounts and bulk license discounts that can be applied and our sales team will work with your site to maximize your benefits while minimizing your costs. Below are some examples of what a site might expect for costs:

Example 1: 200 users with Electronic Logbooks only. This solution would cost the organization between $90,000 and $120,000 annually.

Example 2: 500 users with full ARCBook integration. Including Logbook, Forms, and Batch Records. This solution would be nearing our maximum cost with an annual recurring cost of $315,000 to $345,000.

Included within the costs above are:

• Annual License Fee
• Duplicate Server Hosting
• Software security and insurance
• 24/7 IT support
• All updates for improved performance and requested features