January 26, 2016

FAQ

Here is our list of frequently asked questions. Questions are arranged by topic.
 
1. Getting Started
 
2. Lost Password/Login
 
3. Technology
 
4. General
 
5. Training
 
6. Administration
 
7. Materials
 
8. Specifications
 
9. Projects
 
10. Inventory
 
11. Batch Records
 
12. Logs

1. Getting Started

 
Can I visit the site and audit the system?
You can visit headquarters in Cary, NC and audit the system documentation for one full day each year at no charge. Any additional visits or time will be charged at normal consulting rates.
 
Do I need to validate the system?
No; InstantGMP has already validated the system. Since it is in the cloud, you are not responsible for performing full validation; but a qualification using a dry run is a good exercise to write a memo for.
Can we see the validation records?
Yes; you are welcome to set up an adobe connect meeting to view the documentation, or visit us in Cary, North Carolina.
 
How do I delete a record?
Once some information is entered into InstantGMP, it cannot be deleted. It was designed this way to be in compliance with FDA requirements for electronic documentation (21 CFR part 11) and with the best practices of cGMPs.
 
How do I get to my instance?
Your InstantGMP Support Specialist will send your link in an email. This is the only way to access your instance, there is no way to search for or look up your instance. Please save the link as a favorite as well as save the email as a file for future reference. This email will also contain your login credentials.
 
How long does it take to implement InstantGMP?
In general/overall, a couple of weeks. Orientation training is a one hour session. The homework spreadsheet and questionnaire can take some team work to gather data, so implementation is hinged on both that data and scheduling of the technical training. Tech training entails two 2-hour remote web sessions where the Project Manager and the Quality Manager “drive” with hands-on experience.
 
Should we pay for a “GMP Compliance Certification?”
Paying for education and an audit of your facilities can be beneficial if you are new to the regulations world. The goal is to implement long lasting parameters for doing business with integrity and retaining loyal customers who appreciate high quality products. A certification does not indicate continued compliance and in the end, the FDA has the last word. Remember that the FDA does not certify compliance, only third parties do so. With more and more access to information and in turn a more educated and aware consumer public, a certification gives the consumer a sense of security and that translates to business.
 
What is "MES?"
MES stands for Manufacturing Execution System, and is a tool for use in electronically managing records and capturing Master record and batch data.
Why do I not see the same screens as other users
The system has a built-in security scheme that allows each role to see the screens where that role should have access to work.
 
Will InstantGMP work on an IPad or Android tablet?
InstantGMP software is cloud-based, which means that you do not need to install anything on your computer - just a web browser, specifically, Mozilla Firefox. Cloud-based software gives users flexibility on the type of device used in their facility. InstantGMP can run on desktops, laptops or even mobile devices such as tablets.
 
Which mobile devices can run InstantGMP software?
InstantGMP software can be run on any mobile device that has the full version of Windows 7 or 8.1 and has the Mozilla Firefox browser installed. Here are a few suggestions:
*Lenovo Yoga Tablet 2 with Windows 8
*Acer Aspire Switch 10 Tablet 2 in 1
*Microsoft Surface Pro
*Microsoft Surface Pro2
*ASUS Transformer Book T100
 
Can InstantGMP be used on an iPad or Android?
InstantGMP is not yet optimized for the Safari browser, which is the only internet browser that can be used on an iPad. It is not optimized for Android operating systems.
If you have questions about whether or not InstantGMP can run on your device, please contact support.

2. Lost Password/Login

 
How did I get locked out/disabled?
After 3 failed login attempts, users are locked out of the system and marked disabled on the personnel screen. "User is disabled. Please contact Site Administrator".
 
How do I add more users?
If you have exceeded your number of user seats, please:
 
Robert Pochadt
Director of Sales
215-968-5414
rpochadt@InstantGMP.com.
 
How do I change my password?
If you have been assigned administrative permissions, expand the personnel page, select the update arrow and change and confirm your password. If you do not, you must find a Project Manager with Admin permissions to get to the screen for you.
 
How do I enable a disabled user who can’t log in?
Anyone with administrator rights (as checked in the box on the personnel page,) including the site ADM can go into the personnel screen, select the update arrow for the user who has been disabled, and select the (green check in the) check box for disabled. This will enable the user.
 
How do I get logged on?
Logging on is a simple procedure. You will need an internet browser and the web address for your private database access. Your system administrator can provide the web address which will open up this Login screen.
 
My signature was not captured. What happened?
Signatures must be confirmed within the credential entry popup box and on the page the record will reside. Always be sure to confirm signatures before leaving the page. This includes before using the inventory in the manufacturing instructions as well as before using the test button in specifications.
 
The system won’t let me add more personnel; why?
The package your team purchased included a set maximum number of users. You have reached that maximum.
 
User is not disabled but still cannot log in. What is wrong?
If a user tries to log in and NO error message displays, the user has not been assigned a role so the system does not know what permissions to grant. A Project manager or someone with Administration Rights Permissions can go to "Personnel" under the administration menu and assign a primary role and/or go into a project under "Project Personnel" and add a user and role.
 
Who is my site Administrator?
Your site administrator is the person in charge of IGMP at your site, most likely the initial PM Project Manager who attended the training technical sessions. Their email is to be set in the email field for the ADM in the system so that they will receive email alerts regarding users’ failed login attempts and user lock outs.
 
Why can’t I log in?
There are a few reasons you are not able to log in.
1. You are not typing your password correctly. Check to see that your number lock and caps lock are off.
Remember that your user ID is a formula: First letter of your first name + first 7 letters of your last name + (in most cases) 01. Default training passwords are assigned and sent via email.
2. You have not been assigned a role. Have your Project Manager assign you a role for any project under "Project Personnel."
 
Why did I receive a warning about logging in?
After 3 failed login attempts, users are locked out of the system and marked disabled on the personnel screen. "User is disabled. Please contact Site Administrator".

3. Technology

 
Does InstantGMP use directly attached storage such as a hard drive or RAID?
All InstantGMP data is stored on cloud servers with redundant storage system. In addition, the cloud server features redundant power supplies, backup generators and multiple internet service providers.
 
Does the software run natively on its server hardware or is it virtualized?
The servers operate as part of a VMware cluster which allow us to move the application and/or database server to different hardware if required. The hosted system is a cloud application. Installation at a customer's site is available on request.
 
Does the system reside on a fixed set of servers or it supported across many possible servers?
All InstantGMP applications are hosted on a single set of fixed servers that are in our secured, hosting facility.
 
Does the system share server hardware, software or storage with other customers?
Each customer is assigned a unique, separated database to protect the integrity of their data.
 
Have there ever been security breaches?
There have been no security breaches in 9 years of operation.
 
How are the systems backed up?
All InstantGMP data is stored on a redundant storage system using RAID with hot spare drives. In addition, the storage server features redundant power supplies and storage processors. The storage server is maintained with a support agreement which covers software upgrades and next business day availability for replacement parts. All data is backed up off site nightly.
 
How’s the data center physically secured?
The data center where the hosting servers reside are physically located in Durham, NC. Only authorized IT personnel have access.
 
Is there a firewall between the system and the Internet?
There are firewalls on each internet connection. The firewall provides security protection against any attacks on the network, as it only allows incoming traffic that is required for the application to function.
 
Is there power redundancy at the server location?
All application and database servers have redundant power supplies and are maintained under support contracts to cover software updates, as well as next business day availability for replacement parts.
 
Is there remote hardware redundancy?
All application and database servers have redundant power supplies and are maintained under support contracts to cover software updates, as well as next business day availability for replacement parts. The servers operate as part of a VMware cluster which allow us to move the application and/or database server to different hardware if required.
 
Where are the systems' servers physically located?
The InstantGMP cloud servers are located in a secured, dedicated, environmentally controlled hosted computer center in Durham, NC.

4. General

 
When I add new entries, nothing happens, they don’t appear in the list/in the results.
1. Check that you are not entering new data in the search field.
2. The data was not was not confirmed. Ensure that confirm is always selected to save a record.
 
Where did the insert button go?
The insert button will not appear on every screen if you are logged in as a Quality Manager. Toggle over to your PM role and refresh the screen by selecting the refresh button in your browser, or F5 on your keyboard in windows (command/apple + R in IOS) and the buttons will reappear. Roles have certain responsibilities and permissions; QA has less ability to start records and more ability to Quality check and sign on records.
 
My signature was not captured. What happened?
Signatures must be confirmed within the credential entry popup box and on the page the record will reside. Always be sure to confirm signatures before leaving the page. This includes before using the inventory in the manufacturing instructions as well as before using the test button in specifications.

5. Training

 
Do we have to complete the "Dry Run Preparation Spreadsheet?"
Yes. Completing the sheet is necessary to organize your info and for devoting all of training time to learning the InstantGMP workflow and functionality. If the spreadsheet is not completed, training sessions will have to be rescheduled.
 
How do we train? Where?
Training is completed remotely via join.me and phone conference. Your team will share your screen and get hands-on experience using InstantGMP. Training videos are available in our resource center.
 
How long will it take to implement the system?
Avg: 3-6 months. From purchase to producing, your team can be up and running in two weeks if you are familiar with GMPs, have a team that knows their products and processes, attend training sessions as recommended and make implementation of InstantGMP a priority. In theory, your team can be producing the product modeled in training as soon as the training is completed. Proficiency in using the system  Implementing a full set of SOPs, training employees and using the system proficiently may take a year. Depending on your organizational, GMP and production goals, this time frame can be shorter or longer depending on how quickly you can gather the data import spreadsheet info "homework" and the calendar availability for training session appointments. In general, your team can be producing the product modeled in training as soon as the training is completed. There is a one-hour orientation training, a homework check session and there are two 2-hour "train-the-trainer" sessions and there may be some additional training and data entry of material information to complete before being able to go live with the system.
 
How many people need to go to the technical training session?
One Project Manager and one Quality Manager are required to attend both technical Train-the-Trainer sessions. Please be aware that you will share your screen. Taking notes is encouraged as you may be responsible for training other team members.

6. Administration

 
How can we procure a specific material from multiple vendors?
A material is not tied to a vendor and as long as you uniquely identify lot numbers your traceability from raw materials to batch records and vice versa will be transparent.
 
How should I map out my different material types?
1. Enter each physical property category for each material type. E.g. powder/ raw, liquid/raw, crystalline/raw, powder WIP, powder FG, etc.
2. Create new categories for other materials you would like to track use for in inventory.
3. If you have a few bottles, boxes, labels, etc; create one category called “Components/ Raw”
4. If you have many varying types of each bottles, labels, desiccants, packaging etc.; then create categories “bottles/raw,” “labels/raw,” “desiccants/raw.”
 
How should we number our equipment?
IN THE PHARMACEUTICAL INDUSTRY IT IS COMMON TO USE THE CONVENTION OF A THREE LETTER ACRONYM FOR THE TYPE OF EQUIPMENT AND THEN A DASH AND THE SEQUENTIAL NUMBER OF THAT TYPE OF EQUIPMENT. E.G. SCL-001 OR FIL-001.
What if we do not control our environments or we do not monitor them?
Ambient can be used to signify this. Alternatively, if you do use a controlled ambient temperature, you can modify "Ambient" to say "68-74 degrees F," for example.
 
What if we procure a specific material from multiple Vendors?
We have a workaround that saves a lot of time outlined in a separate worksheet you can ask your InstantGMP Support Associate for. Essentially, instead of naming individual vendors, use a group name for the material; e.g. “Garcinia Cambogia Vendor Group” and name individual vendors under distributors. Then for ordering and upon receipt of the material indicate the vendor and the lot number. This allows for all vendors to be tied to one part number, which makes MPR writing and production easier.
 
What information do we need to enter Equipment? Do we need to have an equipment number?
Equipment name and Number are mandatory for the system to create a record. The serial and model number are optional and can be added later. Ensure that the number recorded in InstantGMP is also recorded on the equipment itself. We suggest using a label maker or an inscriber that can be purchased at art and home improvement stores.
 
What other Material Statuses would be useful to add?
"QA Retains," "Approved for R&D," "Conditionally Approved," "Ready for Shipping," labeled/unlabeled, etc.
 
What should we name our “Facility?”
Use a corporate/HQ name, an internal code for which branch it is, etc. e.g. "BPI North Campus"
 
Why should we enter our own company as a vendor?
For the products you produce, you are the vendor.

7. Materials

 
Can I Import Materials into InstantGMP?
Vendors and Material names can be imported into InstantGMP MES or InstantGMP Vape at any time; Instructions and a spreadsheet for downloads can be found here [http://www.instantgmp.com/Support-Data-Import].
 
We use a material management software; is there overlap?
InstantGMP does not track pricing, but the inventory management has many QA checks and balances and best practice is to use the requisition and receipt of materials so that you can use the materials in real time and ensure that they are in an approved status. Our customers typically create redundant records for “material receipt” records and agree that the overlap is better than a gap.
 
Where are materials 1-146? Can I add my own legacy number?
The system starts at part #146 and assigns them automatically in sequential order, whether the materials are Raw, WIP, or in-house WIP or FG. Version 2.038 only allows for custom entries of batch Production numbers; a future version may include this capability for part numbers.
 
Where can I enter our own part numbers for raw materials? We do not want to rely on automated numbering in InstantGMP?
There is a field for "Material ID" on the TMaterial page for entering general Material data; this field will carry along with the automated part number throughout the application.
 
Where did my material receipt go?
Once a material is received it migrates to the Inventory Status main menu tab with a status of Quarantine.
 
Where did my material specification go?
Once material specifications are confirmed, with or without signature, they travel from the "Select Part# to Version Up" page to the Material Specification page. The update arrow will allow you to add signatures and tests.
 
Why is the material with Quality signatures for specifications not showing up in the selection list for project definition?
Check that the material is in the list on View material specifications. If a Quality signature was received and the PM signature was not, that spec is locked in limbo. The system will not provide a link for you to create version 2 because it thinks version 1 is still being worked on. It will not allow the material to be used because it sees the PM signature is missing.

8. Specifications

 
Where did my material specification go?
Once a material specification is confirmed (even with no data, with or without signature,) they travel from the "Select Part # to Version Up" to the Material Specification page. The update arrow will allow you to add data signatures and tests.
 
Why is the material with Quality signatures for specifications not showing up in the selection list for project definition? (or MPR bill of material selection list)
Check that the material is in the list on View material specifications. If a Quality signature was received and the PM signature was not, that spec is locked in limbo. The system will not provide a link for you to create version 2 because it thinks version 1 is still being worked on. It will not allow the material to be used because it sees the PM signature is missing. A new part number for the material must be created.
 
What is a test vs a method?
A test is the attribute quantity or quantity that is being evaluated. Think of this as the objective of your actions; what is it we want to find out? Weight? identity? pH?
A method is the way in which we will measure such attributes, for example weighing, HPLC assay or using a pH meter.

9. Projects

 
Can we take people on and off the projects and give and revoke signature responsibilities for the MPR and BPRs?
Yes; navigate to the project personnel page, select the update arrow for the project in question and de-select eh MPR and or BPR signature check box. If the user in question is no longer employed there, then confirm the current data on the Tprojectpersonnel page. The next screen will allow you to select the red x to delete a person off the project.
 
How Do I assign a user a role? How do I assign them to a project?
1. Ensure that the User is set up on the Personnel page with a User ID and password.
2. Navigate to Projects in the Main Menu and then to Project Personnel in the sub menu
3. select the User's name and a job title and confirm.
 
If you are a PM who is helping to set up another user, you know a project has been created, but you cannot see it, contact the PM or ADM who set up the project and he or she can add you to the project following the above steps.
Note: If you have not gone through training and there is no project, contact your InstantGMP Support Specialist who will add you to a hidden project.
 
Why can’t I see my project?
If you are using version 2.028 - 2.030 and have created the project as a Project Manager without Administrative Rights, You will need to have the site ADM or someone with Administrative Rights add you to that project with your role before you can log in under that project.
 
Why should we enter our company as a Client?
For project that you are completing, labeling holding or shipping, you may be seen as the client. You can name your company as a Client if you have many products that you make under different labels or from different formulations and you would like to have your client code help differentiate between Batch records for identical formulations with different labels, for example.
 
Why should we enter our company as a Client?
For a project that you are completing, labeling, holding or shipping, you may be seen as the client. You can name your company as a Client if you have many products that you make under different labels or from different formulations and you would like to have your client code help differentiate between Batch records for identical formulations with different labels, for example.

10. Inventory

 
What if only half a shipment came in?
1. Create a new requisition for the part # and receive the new shipment with the same or a new lot number, etc.
2. (If the lot number is the same and both split lots were received in the same day,) Go to the “Inventory Use” screen, select that receipt and enter a material use entry with a negative amount to account for the addition of more product into the receipt with the same lot number. Use the purpose field to indicate split lot receipt.
 
Where can I attach SOPs, spreadsheets, COAs, etc?
InstantGMP™ MES and InstantGMP™ Vape allow attachments to the cover page of the Master Record and to any manufacturing instructions steps. You can attach word documents, Excel spreadsheets, images or PDFs. There is a limit of 2 MB per attachment.
 
Why does my finished good in inventory have a zero for a requisition #?
The finished good was never requested, and it was entered into the inventory via the "add batch to inventory" button, so it does not have a requisition number.

11. Batch Records

 
Can I sign for someone else on the batch record? Can we share login credentials?
The login credentials are to be kept safe and not shared. This electronic signature is a legal signature and binding; you only want to sign for things that you actually performed. Signing for someone else in the batch record goes against FDA regulations as it interferes with traceability.
 
Can we revoke signature responsibilities for the MPR and BPRs?
Navigate to the project personnel page, select the update arrow for the project in question and de-select the MPR and or BPR signature checkbox.
 
Should I enter all of my in-process tests in the in-process tab or in the manufacturing instructions?
The In-Process test tab is a read-only tab and is a good reference for both operators and quality reviewers to check against the list. If, however, your team finds this screen redundant, you may of course only enter the tests and methods to be used in the MPR manufacturing instructions. This way, more information is on-hand at the point of reference when the operator is on that step in the manufacturing process. It is helpful to enter the number of the step from the instructions to the in-process testing.
 
Should I enter all of my in-process tests in the in-process tab or in the manufacturing instructions?
The In-Process test tab is a read-only tab and is a good reference for both operators and quality reviewers to check against the list. If, however, your team finds this screen redundant, you may of course only enter the tests and methods to be used in the MPR manufacturing instructions. This way, more information is on-hand at the point of reference when the operator is on that step in the manufacturing process. It is helpful to enter the number of the step from the instructions to the in-process testing.
 
What if we are only packaging, holding or shipping?
Define the incoming finished product as an internal WIP. Use the MPR for labeled, packaged, etc. product to indicate the steps you take to ensure that measures are taken to procure MPRs, BPRs, COAs, etc. as well as any steps your company takes to hold, label, test, etc.
 
Where can I enter my own batch record number?
We do not want to use the InstantGMP automated number system. There is a field on the Batch Cover page for "Production Number" that will populate tables for traceability.
 
Why can’t I make a batch record from the Master Record?
Make sure all the required approval signatures for that Master Record have been confirmed, and try again. The Master record should now be a drop-down choice to make Batch records from.
 
Why can’t the operator get into a batch record to record results?
The Batch record has not been issued. It will unlock (and be editable) upon confirmation of QM signature on the BPR cover page via the update button and issue button.

12. Logs

Can we print equipment and room logs?
Custom reports can be written to print logs. Contact Robert for pricing:
 
Robert Pochadt
Director of Sales
215-968-5414
rpochadt@InstantGMP.com.
 
Do we need to number and label utensils?
The FDA does not require forceps and other small utensils to be individually numbered, but they should still be controlled and cleaned.
 
If you still need assistance, please contact the support specialist.