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TheraCannSYSTEM QandA

Frequently Asked Questions

TheraCannSYSTEM provides a complete Enterprise Relational Process (ERP) ISO 17025(2005) and Safe Quality Food (SQF) compliant Web based software designed to manage strict regulatory requirements with respect to quality assurance, document & and patient prescription management, inventory tracability & recall, and auto-worklow assignment of critical reportable events.

TheraCannSYSTEM Q & A

Managing Recreational & Medical Regulatory Purchase Requirements

Q: Once the recreational regulations are in place, will TheraCannSYSTEM software be able to generate customer orders even if no medical report from a doctor?

A: Yes, TheraCannSYSTEM is able to separate medical from recreational cannabis consumers. It is also designed to be vertically integrated to ensure full traceability of every gram as well as each penny procured.

ISO 17025(2005) Compliance and Off Site Locations

Q: On your web page at http://theracanncorp.com/our-products-2/theracannsystem/ it states “provides a complete Enterprise Relational Process (ERP) ISO 17025(2005) compliant. As one who sets up and audits this program for other clients can you please elaborate on ISO 17025 would apply to this second location if they have no in-house lab (i.e.: no HPLC or GC). i.e.: would this be for helping with the calibration of the weigh scales & analytical balances? pH & EC meters? Has the software been accredited by a member of the SCC? I can’t seem to find the accreditation body’s logo on your site.

A: TheraCannSYSTEM includes but not limited to a LIMS module, an Assets module, a Document module, a Trouble Ticket module, a WorkFlow module to incorporate laboratory methodologies and chain of custody record keeping that is ISO 17025(2005) compliant. Laboratories that had utilized this core functionality have been certified by ILAC accrediting bodies as early as 20010. Keep in mind that TheraCannSYSTEM is a tool for labs to utilize as part of their certification and accreditation for ISO 17025(2005). ILAC does not accredit software, rather they accredit laboratories that have in place the appropriate procedures, tools and methodologies to meet their rigorous requirements.

 

Has any of the hardware & software been validated ?

Q: Has any of the hardware & software been validated for installation qualification (IQ) and operational qualification (OQ), including “sufficient controls to prevent unauthorized access or changes to dataas per any of Health Canada’s guidance docs such as for GMP, GLP, GCP (collectively GxP)?

A: Of course. First approved in February 2014.

What do you offer that others do not?

Q: What separates your software / company / service / pricing over others in the industry?

A: Unlike other software providers who are providing a software that is not fully configurable, and not part of a full solution including application, plan, design, implementation and ongoing support of the facility, including integration to the 3rd party vendor software that is located on site, and not including a full FinCEN compliance solution to managing transactions, an ISO 17025(2005) compliant LIMS, and a Safe Quality Food (SQF) compliant product tracking module, TheraCannSYSTEM is designed to be the only software required to manage all aspects of day to day operations.

Integration to 3rd party Controllers?

Q: Can the system be tied into online environmental monitors for temp & % relative humidity (%RH), EC & pH of the water, HVAC, security equipment, etc?

A: TheraCannSYSTEM has also worked with a variety of cultivation, extraction, pack & label and security providers to provide direct integration to their software systems to pull key performance indicator (KPI) information and store within TheraCannSYSTEM for future reference and / or correlation to other KPI’s such as product performance, trouble ticket, and report generation.

What kind of data metrics are available?

Q: Per the brochure at http://theracanncorp.com/wp-content/uploads/2016/09/TheraCann_BenchmarkSOLUTION_v1.pdf since I’m a numbers junkie what kind of data metrics are available?

A: Unlike other software programs that provide a fixed list of reports or require customization of a reporting module, the TheraCannSYSTEM module is designed to be configurable and adapt to Client reporting requirements. By providing a module to module, field to field relationship the limit is really just the Clients imagination.

How does licensing work with a second location?

Q: If the licensed location wishes to integrate to an off site laboratory (a second location), what is the cost for the initial installation & set-up? And for each user on the system? (assuming 8 users). Please include monthly, yearly, and other costs such as software patches, customer support, etc. including on-site vs. remote.

A: Firstly, TheraCannSYSTEM is sold as part of TheraCannSOLUTION which is a complete turn-key solution to the Cannabis Sector. It is not sold independently of an existing contract to provide a turn-key solution and is therefore not priced separately. Once licensed as a Software as a Service (SaaS) it provided unlimited licenses for the licensed location and is licensed on a per location basis.

Can auto-notifications be sent by email for Recall events?

Q: If there is a product recall and we want to notify all the individual & wholesale clients via an email blast, will the software be able to do that?

A: Of course. TheraCannSYSTEM will also provide auto workflows to manage this recall as either a voluntary or mandatory.

Do we have control over the brands of peripherals, such as label printers?

Q: Do we have control over the brands of peripherals, such as label printers?  i.e.: can we chose & purchase those ourselves such as through NCIX?

A: Most printers are providing universal connection to PC. Provided that your PC is able to connect to the printer you will be able to purchase / select your own printer. Provided that your label size and label configuration is not unique, TheraCannSYSTEM’s PDFMaker module is capable of printing directly to your label maker.

How can access be limited to suit the size of our operations?

Q: Since our second facility is initially going to be relatively small, and certain aspects may be administered by our parent company, are there various modules that could be installed on the server at the second facility (i.e.: production & QA) while other modules on the parent server (i.e.: financials)?  

A: TheraCannSYSTEM is designed to limit access to different modules and fields on a per user or per group of users basis. That way, a group that does not need to have access to certain modules or portions of modules will not see them. Individuals that need access to specific modules and / or fields would have unique access to them.

Can the financials be easily exported into other programs?

Q: Can the financials be easily exported into other programs such as Sage or QuickBooks? Can QC data be exported into MS Excel?

A: TheraCannSYSTEM modules come with a native easy to use import and export function. Module files are exported nativley as .csv files. Reports from the TheraCannSYSTEM report module can be exported as .xls, .csv, .doc and as .pdf. Report integration to QuickBooks is available and provided that your accounting package has provided an API to work with we can also look to integrate to that API.

How does TheraCannSYSTEM handle SOP's and auto-workflows?

Q: Assuming all of the SOPs can be loaded into this system, is their format / structure layout / order of sections all pre-set by TheraCann? Or is this all totally customizable by the client?  i.e.: they create the SOP in MS Word, then simply upload it into the system? Then, within that SOP, let say one of the steps states “First clean the extraction unit as per SOP “SANI-011” whereby the underlining is actually a hyperlink, so that one can click on that link and pull up that SOP in a new tab?

A: Its actually simpler that this and more reliable. Linking to documents that are likely to be obsolete (and old version of the SOP) or that fail to also include video, audio, YouTube and rich text access would be considered “old school”. TheraCannSYSTEM has a built in workflow that builds procedural steps (Project Tasks) that provide the operator with all they need to know what to do, including link to rich text, video, audio, YouTube, GoogleDocs etc.

How much access does TheraCann have to TheraCannSYSTEM?

Q: If the clients uploads all of their SOPs into the system, does TheraCann have access to it? Since this would be the client’s IP, I prefer that TheraCann only be provided access to those SOPs on an as needed basis. i.e.: the on-site server administrator sets up a temporary access for you.

A: Our Clients provide TheraCann with as much or as little access to their instance as they prefer. However, if you wish TheraCann to create your own workflows and be provided support or help in creating or supporting those workflows, then just let us know.

What permissions does an onsite administrator have?

Q: Regarding an on-site server administrator, what permissions would they have? i.e.: if a new employee is hired, or a present employee’s job description is changed such that they need to levels of access to certain modules, can that be done in-house? Or does that have to be done (remotely) by TheraCann? If that has to be done by your company, roughly what would the charges be?

A: Access by authorized “Users” of TheraCannSYSTEM is governed by roles and roles can be defined in groups. Each role is accessable by the Client to provide a one to one relationship between access to module and fields within those modules and whether the User has ability to edit or move to the “archive folder” as no files can be deleted from SYSTEM. TheraCannSYSTEM comes preloaded with recommendations for a typical cannabis producer, processor and distributor operation and those can be easily edited to confirm permission settings. New employees can then be easily added by selecting the group in which they belong to auto-add those permission settings.

Where does TheraCannSYSTEM fit within the world of ERP software modalities?

Q: I just found a fluff whitepapers on ERP that I downloaded a couple years ago. Would your software be considered “process” or “discrete”? The two primary categories of ERP manufacturing software, process and discrete, function in very different ways. Process ERP software works by utilizing various receipts and formulas. This allows for significant quality control testing functionality, as well as extensive tools to manage lot control and traceability. Derivatives of process manufacturing include food, beverages, pharmaceuticals and other chemicals. Whereas, discrete manufacturing produces items such as automobiles, appliances, and computers, products that are able to be disassembled. Before making an ERP software! decision, first you must define what niche of manufacturing your company is categorized as.

A: Such definitions are too restrictive to define current web based ERP software systems. As systems they must be able to adapt and apply to existing client requirements. As such TheraCannSYSTEM includes both “process” and “discrete” functionalities based on your definitions above.

Does TheraCannSYSTEM comply with FDA’s 21 CFR Part 11?

Q: If electronic signatures can be used, has the system been validated as per FDA’s 21 CFR Part 11?

A: TheraCannSYSTEM does utilize signatures from authorized Users tasked with critical sign off activities. We comply strictly with FDA’s 21 CFR and have since 2010.  TheraCannSYSTEM authenticates and tracks each user from point of login through their login session.  Addition or new records, changes made to records, are recorded and easily accessible to future auditors bot as current version, previous version and archive versions.  TheraCannSYSTEM, by design, is able to validate the accuracy, reliability, consistency intended performance and ability to discern invalid or altered records.   Auto-workflow ensures that appropriate authority checks / operational system checks are performed by Users deemed proficient in their use.