Frequently Asked Questions - Access Database
Trial Version
Q. What is in the Trial version?
The trial version of the software provides a better idea of the software operation before being purchased. Trial version has all the functionalities like the unrestricted version. Note: Trial version is restricted to raise five records and reports.
Q. How to download a Trial version?
You can download a trial version instantly by pressing the Trial button from the site. No personal information is required. You can save the trial database in your hard drive (shared) like any other Access database before use.
Note: It is recommended to delete the trial version before using the unrestricted version in order to avoid any possible confusion.
Q. I can not raise more than five records in a trial version, what do I do?
Trial version has the restriction to raise five records. We believe this limitation is fair to test the functionalities of the software. If you would find the software is useful and fits your purpose, you may purchase the unrestricted version from the site with affordable one time cost.
Q. I do not have time to test the trial version. Can someone help me with a demonstration?
We will be happy to demonstrate the hands on software operation if that is preferable to you. Please let us know your preferred time and location. We can organize a webcast presentation for you.
Q. I have already raised five records but my testing is not completed. Database is not allowing me to work any more. What do I do?
This is the issue with the trial version. As you raise five records quota system won't work anymore. If your testing hasn't completed yet, please log in as an Administrator and delete some records from Record List. This will enable the database to work again.
General Software Operation
Q. What qualify your software to use in a GMP facility?
The development team of Lean-Q software has long years of industry experience specially on the quality and compliance systems for the life science industries. All lean-q software applications have built in features such as strong user authentication, record change management, audit trail, electronic signatures with real time stamping, capable to hold large database, separation of duties by authority etc. For details of the Lean-Q systems GMP compliance please refer to the link GMP Compliance.
Lean-Q team will be delighted to adapt all constructive suggestions to make the software applications more GMP compliant within the scope of the industry.
Q. Can I use the records and reports for GMP audit purposes?
Absolutely. The records and reports generated through Lean-Q system are permanent, and retainable for the complete life cycle of the application. The reports generated by the software are accurate, reliable and can be converted to commonly known document formats (such as pdf) and exported to local hard drive easily in a single click.
Lean-Q software applications are designed to document investigational information which were collected and analyzed in real time. The built in electronic signature management capacity can authenticate the investigation information and the electronic records. Consequently, the records and reports can be used for GMP audit purposes.
Q. Will your software work in a shared / network environment?
The software will work in a network environment. Each unrestricted version of the database is split into two files. For example, when you will download the Out of Specification investigation database, you will receive two files. One as OOS_be.mdb file and the other is OOS.mde file.
These two files MUST be kept in the same folder in order for the linked tables to work.
OOS_be.mdb is the backend of the database that contains the tables only. The OOS.mde is the front end which is linked to the backend tables where the records are kept.
The splitting of the database is recommended when a database is used in a shared environment. This also makes it possible to use the software in a network environment.
Q. How to make back up copies of the database? How does it work?
After the software being downloaded, unzip the files ( _be.mdb and .mde), copy and save the files together into two separate locations. For example, one set should be saved in a backup folder as a backup and the other set should be in a shared location from where every user will access the software.
The database is designed to replicate the working file data into the back up copy as long they are kept in the same network environment. In case, the file in the shared network (working) will get lost or be corrupted, the back up data will be allow to continue to work.
Q. I get two files in a Zip folder. Should I keep both?
Yes. You must keep both _be.mdb and .mde files in the same folder for running the programs.
Q. I get file with the extension .mde. Is this useful?
.mde files are compiled version of the software. In order to keep the database project secure and protected from unauthorized changes, the databases are compiled to .mde format. This is extremely useful for running the software without unwanted error.
Q. How can I get the Administrator password to start with?
The default administrator password for all database is ‘newuser’ to start with. It is strongly recommended to change the Administrator password as soon as the software will be activated.
Q. Is there a password format for the Administrator and the users?
Yes. The password length must be between 6 to 12 characters. Password must contain a combination of letter and number in the format. It is highly recommended to keep the Administrator password secure and retrievable.
Q. I can login as an Administrator. What is next?
After changing the password for Administrator, the next step is to setup new users. Admin must setup new user adding their first name, last name, work position and a password. Without a password the new user will not be able to access the database.
Users are strongly recommended to reset their password which was initially set up by the Administrator. The new user password will replace the initial password and will remain anonymous to Administrator.
In case the user would have difficulty to remember their password, the Administrator can set up a new password for the user which can be changed again by the user.
Q. What are the differences between the integrated modules and individual modules?
As opposed to individual Access databases, the Lean-Q system integrated module is developed in MS.NET environment.
Lean-Q integrated quality systems software is a strongly GMP validated application where all modules are integrated into one single interface. The modules are Product Complaint Management, Deviation Management, Change Control Management, Corrective and Preventive Action, Out of Specification Management. Lean-Q integrated software is fully compliant to FDA 21 CFR Part 11 requirements. The software is only available for subscription. The evaluation version is available to download from the site http://www.lean-q.com/Trial.html
Q. I can not edit a saved record. How to edit a record once saved?
Once a record or part of a record is signed and saved, the record locks itself and can not be edited further until the user sign off for the change of the records. This is designed to keep the authenticity of the record and forces the user to perform due change management before changing a GMP information.
In order to change a record, please go to the Change window located at the top of the application, select the name of the section where you want to make the change and Submit. A sign off window will appear. Write your comment on reason for the proposed change and press OK. The section off the record will unlock for edit.
Q. Can I delete a user from the system?
No, you can not delete a user from the system. We have found the option to delete a user may compromise the accountability of a GMP record. In order to maintain the GMP records with proper authenticity, users name and credentials should be kept on the system for the time a GMP record should be legally retained.
Q. I have mistakenly raised duplicate records for the same issue. Can I delete unnecessary records?
Only the Administrator has the privilege to delete a record. From time to time, records may be raised in duplicate or deemed unnecessary. In those situations, it may be necessary to delete the blank record from the system. As a result, we have designed to give Admin the permission to delete the unnecessary record.
Q. Where is the Audit trail report?
Audit Trail keeps the workflow history/log of a record. This is generated as a stand alone report for any single record selected including the comments for completing a step, comments for record change, the user’s name, date and time of signatures who has performed the action on the record.
Audit Trail is the second report from the top of the reporting section of each module.
Q. Is your software copyright protected? Can I modify your software?
The Lean-Q software systems are copyright protected under the trade name license of Lean-Q ® and Gmpqualityup is the sole owner of the intellectual property of the Lean-Q systems.
It may be a violation of copyright protection in the case of modifying, unauthorized sharing and duplicating the system or use of Lean-Q system for any kind of unauthorized activities with an intention to benefit commercially without the written expression of the sole owner Gmpqualityup.
For more copyright restriction please visit our site at http://www.lean-q.com/Termsofuse.html
Purchases and Payments
Q. How can I purchase an unrestricted version?
You can purchase an unrestricted version directly from our site shopping cart. The software files are available for instant downloads as soon as the payments are made successfully.
Q. I would like to purchase more than one software, how can I do it?
You can purchase more than software by adding those in our shopping cart. All files will be instantly downloadable as soon as the payments are made successfully.
Q. Do I have to purchase more than one copies of the applications for a single entity?
No. A single copy of the Access database can be used by as many users as any single entity has. Purchasing more than one copy is not necessary.
Q. Is there a return policy?
Due to the nature of the electronic files we do not have a return policy to reverse a transaction unless there is a reasonable explanation for refund. We would suggest the potential user should test the trial version into their systems before attempting to purchase the complete version of the database. Hence, the chance of mishandling of the files will be reduced.
However, there is always unhappy buyer or some buyer may change their mind after purchase. We would suggest those buyers to notify us their true concerns. We may try to organize a refund.
Q. What payment method do you accept?
We accept Paypal as our primary payment method. The purchased databases are instantly downloadable when purchased through paypal. Payment through credit card without using Paypal is also possible. In that case we will raise an electronic invoice and email to your address. You will be able to pay securely by coming to our site. When the payment is successful, we get instant notification of the payment and send you the complete version over the email.
On special circumstances we also accept payments made through wire transfer or by cheque.
Q. My country is not listed in Paypal site. How can I purchase?
Regretfully, some countries are still not listed in Paypal. Users in those locations can not make payments through Paypal. In such cases we can raise electronic invoice as described above. Bank wire transfer or cheques are also acceptable.
Q. Can I purchase without using Paypal?
Yes. Payment through credit card without using Paypal is possible. In that case, we will raise an electronic invoice and email the invoice to your address. You will be able to pay securely by coming to our site. When the payment is successful, we get instant notification of the payment and send you the complete version over the email.
Q. My card payment through the electronic invoice was not successful. What should I do?
Sometime payments can not be made successfully by credit card. In many cases credit cards have limitations imposed by the card issuing authority. Please contact your card issuer for such instances. Also please notify us for an alternative way of payments.
Q. Do you accept wire transfer?
We accept wire transfer as long the fees are adjusted in the final payments.
Q. I have purchased from your site but the download link has expired. How do I get my purchased copy?
In general the download links remain active for 5 days. We expect the user will be able to download the files within that period. If you would find the download link has expired and you were not been able to download the file, please let us know by going to our contact page quoting the transaction ID. We will send you another link as soon as possible.
Q. I have lost my original database. Can you send me a replacement file?
We need to know your transaction ID before sending a replacement file. However, for the sake of security of your data, it is always prudent to keep adequate back up files which would cover your back at the time of need.
General Troubleshooting
Q. What should I do if the software does not run in my system?
Please let us know as soon as possible. We will try to resolve. If the trial version would run without an issue in your machine, so will the complete version.
Q. What should I do if I will get error message?
Please notify us possibly with screenshot of the error message as soon as possible. Although, no stone unturned during our testing of the databases, we can not 100% guarantee that there will be absolutely no error. However, we can assure you that there is no error in the existing version that will prevent the applications from working. If there is evidence of error in the system, we will rush to upgrade the database for all future users and send you the updated version immediately.
Q. Will you fix any problem if I will encounter while running the software?
Of course, we will fix any problem or bug in the software which you might encounter while running the application (although, we hope there are no error). As we have mentioned earlier if the trial version would run without an issue in your machine, so will the complete version.
Q. Can you build similar software with some customized features?
The answer is yes. We will be delighted to get a customization requirements from you and work to change the software only for your use. Customization cost can not be covered by the price stated in the website. There will be reasonable development cost depending on the degree of customization.
Q. What is your office address. Can I contact you if I need more information?
Of course you can contact us either by email or phone. Our preferred way is to communicate through email. Our dedicated team will answer your query in less than 24 hours. We are available in the following office addresses,
160 Targo RoadGirraween, SydneyNSW 2145, AustraliaPhone: +(61) 0401636210Fax:+(61) 02 96883807Email: general@gmpqualityup.comsales@lean-q.comWebsites: www.gmpqualityup.com www.lean-q.com
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