Search Knowledge Base by Keyword
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- How does LabCollector interface look like?
- How does a module generally look like?
- How to set up storage in LabCollector?
- What are fields in LabCollector?
- What are records in LabCollector & how to create them?
- How to start with Antibodies module?
- How to start with Chemical structures module?
- How to start with Document module?
- How to start with Electronic Lab Notebook (ELN)?
- How to start with Equipment module?
- How to start with Plasmids module?
- How to start with Primers module?
- How to start with Reagent & Supplies module?
- How to start with Sample module?
- How to start with Sequences module?
- How to start with Strains & Cells module?
- How to install an Add-on?
- How to use Webinars add-on?
- How to mass update memorized records?
- Show all articles ( 4 ) Collapse Articles
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- How to move a whole installation to a new Windows server?
- How to run LabCollector server on a 64bits Windows machine?
- Install LabCollector with IIS on Windows Server
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- Clean the apache log manually to improve the speed.
- Switching to the ServerManager v2.5 (old way)
- Windows Installation using setup wizard
- How to enable the soap.dll extension using php file or LabCollector Server Manager (Windows)?
- How to use the LabCollector Server Manager?
- How to replicate LabCollector in real time with Windows Server Manager?
- LabCollector Server Manager Upgrade (Windows)
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- Articles coming soon
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- Apache Server/Web server doesn't run on Windows 10
- Clean the apache log manually to improve the speed.
- Clean the logs manually to improve the speed.
- ERROR in log: AH00052: child pid 3461 exit signal Segmentation fault (11)
- ERROR: Warning: mysql_connect(): Client does not support authentication protocol requested by server (…)
- How to make Java applets work again after upgrading to Java 7U51+?
- How to restore overwritten documents
- I have the message "Failed to connect to mySQL server. No Database found for this lab account". What can I do?
- My LabCollector or Add-on is very slow. Why and how to fix it?
- Unknown column “auto_name_mode” in “field list”: The error is occurring when I want to adjust existing records, make new records or import data. What can I do?
- URL issue
- When I add records or any values I have this message: "incorrect integer value: for column 'count' at row 1"
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- Give access to LabCollector to collaborators outside your network
- How can I connect to LabCollector from another computer?
- Can the database be separated from the system on which labcollector is installed?
- I have problems installing PHP and/or MySQL. Is there an alternative?
- Mysql Server memory usage optimization
- PHP extensions needed
- Rack scanners installation and connection with ScanServer
- System Requirements - Hosted options (FR/ENG)
- What are PHP and MySQL? Do I need to have PHP & MySQL?
- How to migrate LabCollector to new Linux Server?
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- How to use LabCollector for COVID-19 testing?
- What are fields in LabCollector?
- How to start with LSM?
- LSMRemote installation steps & Integration into the website ? (v4.0)
- LSMRemote configurable options (v4.0)
- How to configure new fields, submit a job in LSMRemote & view it in LSM?
- How do you create a custom field?
- Custom field types
- How to create a token for report access for patient/client using LSMRemote?
- How to send token and released result report SMS notification using Twilio?
- How to use text editor to create a report template in LSM?
- Dynamic fields in LSM for result/invoice/CoC/batch report templates?
- How to create a Chain Of Custody (CoC) report and use it LSM & LSMRemote?
- How to generate Invoices report template in LSM?
- How to generate CoC Manifest with integrated labels?
- Can I add a custom module to fit my specific needs?
- How to connect and send samples from 'sample receiving' to do tests in 'LSM'?
- How to view samples created in sample receiving add-on into a module?
- How to process plates in sample receiving add-on?
- How to create & process a package in Sample receiving add-on?
- How to perform pooling in sample receiving add on?
- Show all articles ( 6 ) Collapse Articles
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- What is LabCollector?
- How do I install LabCollector? Where can I find the install.exe file?
- System Requirements - Hosted options (FR/ENG)
- How does the remotely hosted version work?
- Can I use LabCollector on a single computer? Can I install it on a web server?
- How do I obtain my license?
- If I purchase ONE license, do I need to purchase additional licenses for other computers in my lab network?
- Client area tutorial - NEW!
- Client area tutorial
- LabCollector support
- What are the FDA requirements for software to comply with GxP guidelines?
- Do I need to purchase all modules? Can I use only the primers module?
- Icons meaning (EN/FR) V.6.0
- Icons meaning (EN/FR)
- How do I search in LabCollector
- Can I see/list all records in a module?
- How do I print records?
- How to add panels to LabColletor v6.0?
- How to create tubes with storage and mark their usage? (v6.0)
- How to create and set alerts for tubes? (v6.0)
- Label network printers and roll types
- Show all articles ( 6 ) Collapse Articles
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- Export and print models
- How do I add multiple records without data import
- How do I link records and for what purpose?
- How do you create or edit records? (FR/EN)
- Icons meaning (EN/FR)
- Icons meaning (EN/FR) V.6.0
- Naming samples for biobanking
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- What can I do with the default fields?
- Can I add a custom module to fit my specific needs?
- Custom field types
- How do you create a custom field?
- How do you create a custom field? For version 5.2 onwards
- Custom field: Field category option version 5.2x
- Custom fields: Tab Analysis option
- How do I customize record options?
- How do I use a Read-only field?
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- What is a CSV file?
- Import your data (v6.0)
- Import your data (5.3 version and above)
- How to delimit data csv for data import?
- What are the default fields values while importing data? v6.0
- How do I format the date value as yyyy-mm-dd or yy-mm-dd to import?
- Import your samples and associated storage in 3 steps
- Import and manage your Reagent & Supplies V5.3 and above
- Importer ma BDD EndNote dans LabCollector (FR)
- How to solve errors while importing data
- How to mass update memorized records?
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- What are user level permissions?
- How do you use versioning? v5.31 and below
- How do you use versioning? v5.4 and above
- How to manage users (v5.31 and below)
- How to manage users (v5.4 and above)
- How to use AD or LDAP for login authentication?
- What are group policies and how to use them?
- What are group policies and how to use them? v5.4 and above
- What are group policies and how to use them? v6.0
- How to manage users? (v.6.032+)
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- Articles coming soon
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- How to start with Reagent & Supplies module?
- Reagent & supplies preferences (v6.03)
- Reagent & supplies preferences
- How do I create alerts for chemical and equipment?
- How do I create alerts with lots? (v6.0)
- Manage your reagent lots (v6.0)
- Manage your reagent lots
- How to do lot disposal
- Risk codes
- How do I manage vendors and sellers?
- How do I print risk and safety data information?
- Import and manage your Reagent & Supplies V5.3 and above
- Manage storage for Reagent & Supplies module
- Manage storage for Reagent & Supplies module (v6.0)
- Manage your lab equipment and follow their maintenance (v5.4 & below)
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- Articles coming soon
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- Articles coming soon
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- How do I create alerts for chemical and equipment?
- How to activate and set different types of Equipment alerts? (v6.0)
- How to activate and set different types of Equipment alerts? (v5.4 and below)
- How to add a new category and record in equipment module? (v6.0)
- How to add a new category and record in equipment module? (v5.4 and below)
- How to add control chart for calibration maintenance of equipment?
- How to add maintenance and activate alert for a equipment (v6.0)
- How to add/edit maintenance for equipment (v6.0)
- How to add/edit maintenance for equipment (v5.4 and below)
- How to export equipment maintenance report?
- What are the options in "display maintenance" section of equipment. (v5.4 and below)
- What are the options in "display maintenance" section of equipment. (v6.0)
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- Articles coming soon
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- How to start with LSM?
- LSM Usage Guide – From Job Request to Results Reporting
- How to set up link between LSM and receiving add-on?
- Insert the LSMremote application in your website
- LSM - Test the LSM API
- Test the LSM API
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- 1st step: Create users and requesters
- How to send samples from LabCollector to a LSM job
- How to link a custom module to LSM?
- How to manage case records (patients, animals...) in LSM?
- How to re-order/re-arrange job & sample custom fields in LSM?
- How to manage range in LSM?
- How to restart a job in LSM?
- I’m able to add a new job with no problems but when I try to start it I can’t do it. The following error appears: Error loading XML document: data/bl/bl-job.php. What’s the problem?
- How to accept jobs in LSM?
- How to create & execute a job in LSM?
- How to create version of test in LSM?
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- 5th step: Result and invoice template
- How to generate Reports in LSM?
- How to create a processing report in LSM?
- How to generate Invoices report template in LSM?
- How to create a Chain Of Custody (CoC) report and use it LSM & LSMRemote?
- How to use text editor to create a report template in LSM?
- Dynamic fields in LSM for result/invoice/CoC/batch report templates?
- Correction/Amendement actions in LSM report
- How to print and follow multiple reports/CoC's in LSMRemote?
- Error loading big reports in LabCollector
- Error loading big reports in LSM
- How to configure header & footer in LSM report/CoC/invoices? (from v4.057+)
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- LSMRemote (v6.0) registration, login and other options
- LSMRemote installation steps & Integration into the website ? (v4.0)
- LSMRemote configurable options (v4.0)
- How to configure new fields, submit a job in LSMRemote & view it in LSM?
- How to search in LSMRemote?
- How to create a token for report access for patient/client using LSMRemote?
- How to generate CoC Manifest with integrated labels?
- How to print and follow multiple reports/CoC's in LSMRemote?
- Patient pre-registration configuration and LSMRemote portal connection
- How to do job pre-registration from the LSMRemote portal?
- How to integrate appointments scheduling in LSMRemote?
- How to enable the soap.dll extension using php file or LabCollector Server Manager (Windows)?
- How to import jobs using LSMRemote?
- How to configure kit and activate it in LSMRemote?
- How to print in bulk the barcodes using LSMRemote?
- How to pay using LSMRemote Stripe or PayPal?
- Show all articles ( 1 ) Collapse Articles
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- Articles coming soon
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- How to start with Electronic Lab Notebook (ELN)?
- ELN LabCollector principles
- ELN page content. What's inside?
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- How to create a Book, add an Experiment and a Page?
- What is inside a Book?
- What is inside an Experiment?
- Whats inside ELN Page?
- How do I print from ELN?
- ELN Workflows
- ELN templates
- TIFF Image usage
- How to electronically sign the ELN pages?
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- ELN - Zoho Spreadsheet Help Guide
- Graph in Flat spreadsheet
- How to change the language of ZOHO excel in ELN?
- How to replicate/import your excel in ELN?
- How to use spreadsheets?
- What is Flat & Zoho Spreadsheet Editor & how to enable it?
- How to use Flat spreadsheet & formulas in it?
- How to make graph in Flat Spreadsheet?
- What can be copy pasted from excel into Flat spreadsheet?
- How make graphs in ELN Spreadsheet?
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- Articles coming soon
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- Articles coming soon
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- Articles coming soon
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- Sample-receiving add-on : Project configuration settings
- How to create & process a package in Sample receiving add-on?
- How to perform pooling in sample receiving add on?
- How to process plates in sample receiving add-on?
- How to view samples created in sample receiving add-on into a module?
- How to add samples created in sample receiving into Workflow add-on?
- How to connect and send samples from 'sample receiving' to do tests in 'LSM'?
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- How to download and Install File connector v2.2? (Labcollector v6.0 )
- How to install Fileconnector in Mac OS? (Labcollector v6.0 )
- Editing a file using File Connector
- How to use a specific software to open certain types of files in fileconnector? (Labcollector v6.0 )
- How to use Fileconnector in Mac OS?
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- How to setup and configure Scan Server with LabCollector?
- Samples batch tool (Rack scanner)
- The rack barcode on top or as third element in lines?
- How to open CSV in UTF8 in Excel?
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- How to configure printer with LabCollector?
- How to connect USB printer to LabCollector?
- Compatible Label printers
- Label network printers and roll types
- Barcode label generation and printing
- How do I print barcode labels?
- How do I print box maps?
- How do I print records?
- How do I print risk and safety data information?
- How do I print storage records
- How to print labels on HTTPS environment?
- How to best configure your PDA N5000 for LabCollector use
- How can I configure my barcode scanner AGB-SC1 CCD?
- How can I configure my barcode scanner HR200C ?
- How do I configure FluidX to support ScanServer?
- Barcode Printer Connection Time Out
- AGB-W8X Manual for barcode scanning
- Show all articles ( 2 ) Collapse Articles
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- How to set up storage in LabCollector?
- How to create boxes/drawers/racks in storage equipment?
- How to create box models for storage?
- How to replicate and duplicate boxes in storage?
- How to store and manage straws? (EN/FR)
- How Do I Add Samples to a Specific Freezer, Shelf or Other Part of the Storage System?
- How do I get out samples from a specific freezer?
- Manage storage for Reagent & Supplies module
- How to organize Storage Browser?
- How do I print box maps?
- How do I print storage records
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- What is in the Compliancy Pack?
- How do I use a Read-only field?
- What are the FDA requirements for software to comply with GxP guidelines?
- FDA CFR21 part 11 product checklist
- ISO 17025 compliancy requirements
- How do you use versioning? v5.31 and below
- How do you use versioning? v5.4 and above
- Should I lock, archive or delete records?
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- How to configure Apache to work with Office 2007 and higher?
- How to speed up your LabCollector? (EN/FR)
- PHP extensions needed
- Speed your local network
- TIFF Image usage
- Time stamp in the records showing incorrect time.
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- Error loading big reports in LabCollector
- Fields with scroll bar don't work with Safari, what can I do?
- I can't manage to view box scheme in Safari, why?
- I get the error: "The program can't start because MSVCR110.dll is missing from your computer. Try reinstalling the program to fix this problem" when installing or updating LabCollector for Windows
- Issue in upload file: look at your PHP configuration
- Module search fails with 404 error or request too long
- When I want to import large files, nothing happens?
- Why do I have the error “MySQL server has gone away” on file upload?
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- Client area tutorial - NEW!
- How to create tubes with storage and mark their usage? (v6.0)
- How to upload/import data in plasmid & sequence modules?
- LabCollector General setup-v6.0
- Purchase order management – A to Z (v.6.0)
- SMS alert setup in Data logger
- Different tools/options in Plasmid Map Editor?
- How to set up link between LSM and receiving add-on?
- How to use 'Plasmid Map Editor'?
The Title 21 Code of Federal Regulations Part 11 (21 CFR Part 11) states the rules with which a company who uses an electronic system for document and signature control, must abide by. It puts forth the U.S. Food and Drug Administration’s (FDA) guidelines on electronic records and electronic signatures to ensure that these documents are authentic and make sure that they maintain the security, integrity, and confidentiality. Companies involved in making drugs, biologics, medical devices, CROs (Contract Research Organizations) and any establishment that comes under FDA regulation must follow stringent controls, audits, validations and other rules laid by them.
FDA CFR 21 part 11 compliancy is provided with LabCollector and major add-ons like ELN, LSM, WorkFlow, and equipment integration with I-Collector.
Full compliancy can be achieved with the compliancy pack that offers various options to follow regulations more stringently. Final validation is however always needed to be performed on the end-user side.
The following checklist is provided as a guide, but AgileBio also provides prechecked certificates and tests to facilitate the lab auditing.
For additional information from about how LabCollector helps to meet additional GxP and regulatory compliance read this Or contact us.
The guidelines by the FDA for electronic data compliance can be found by clicking the link.
The 21 CFR Part 11 Compliance Checklist is described below:-
Name and version of the software |
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The software version should indicate major and minor changes | (§11.10k.1,2) |
Security |
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The access should be limited to authorized users with privileges are assigned to role not individuals. | (§11.10.d,g) |
The password should be 8 characters minimum with alphanumeric characters | (§11.300) |
Password use must be changed frequently with predetermined time period (90 days) | (§11.300.b) |
System must prevent the reuse of the specified number of previous passwords (In 1 year 6 times changed password) | (§11.300) |
Password characters must not be visible during entering | (§11.300) |
Passwords should not be remembered by application or the browser | (§11.300) |
Passwords must be encrypted by the system upon entry and storage. | (§11.300) |
Passwords should not be able to be copied from password field to paste elsewhere. | (§11.300) |
Temporary passwords cannot be emailed without the two-factor authentication. | (§11.300) |
Temporary passwords should be unique | (§11.300) |
Temporary passwords must be changed during the next login. | (§11.300) |
Temporary passwords should expire after a short time period (for example 24 hours) | (§11.300) |
User name should identify the person and should not be generic | (§11.300) |
User name should appear on the screen and should be unique | (§11.300) |
User name/ID should be allowed to be disabled/inactivated as to not reuse it | (§11.300) |
After inactivity of application the system should allow re-entry of the password by logging the user out automatically | (§11.300) |
The system should lock out the user after too many failed attempts with a warning email to the administrator/security staff. | (§11.300.d) |
All user activity should be controlled by login in, log out and lock out. | (§11.10.a) |
Last log in should be displayed when the user logs in. | (§11.300) |
Data Transfer |
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Data transfer should be limited and deleted capabilities should be controlled | (§11.10.d,g) |
Data transfer outside of intranet firewall should be encrypted by security https protocol | (§11.10.a) |
Type and size of input data should have validity check | (§11.10.a) |
The date format should not be ambiguous as the month and should be clearly stated | (§11.10.b,c) |
Audit Trails | |
Audit trail records should contain information about record creation, modification, inactivation, or deletion of electronic records for data & configuration data | (§11.10.c,e) |
Audit trail should contain record user name, date, time, previous data, new data, and reason for change if required by predicate | (§11.10.c,e) |
Users that can change data can access audit trail to see the changes done. | (§11.10) |
For high risk data, the indication that data is changed should be mentioned on screen and not just in audit trail | (§11.10.c,e) |
For high risk applications the audit trail is written by database | (§11.10.c,e) |
Server to be on a centralized time source: server time | (§11.70) |
Electronic Signatures |
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Should contains unique user ID & password | (§11.100.a) |
During signing password should be only known by the user | (§11.300) |
Meaning of signature (author & reviewer/approver) should be displayed during signature | (§11.50.a) |
Electronic signature should show the signer’s full printed name, to show the time and date of execution | (§11.50,a) |
The signed record should be locked from editing and deletion. | (§11.50.d,g) |
Electronic records must be maintained and linked to signatures for the life of the electronic record | (§11.70) |