Good Laboratory Practice (GLP) is a system of management controls for laboratories and research organizations to ensure the consistency and reliability of results. The internationally accepted definition is as follows:
“Good Laboratory Practice (GLP) embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. These studies are undertaken to generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed for pharmaceuticals, agrochemicals, cosmetics, food and feed additives and contaminants, novel foods and biocides. GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments.”
Code of Federal Regulations (CFR)The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for the safety regulation of most types of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics. The FDA also has rules for GLP pertaining to electronic records and electronic signatures. These rules are detailed in 21 Code of Federal Regulations (21 CFR Part 11). Specifically, it relates to the use of electronic technologies for data acquisition, storage and validation
Many pharmaceutical researchers investigating isolated heart (Langendorff and Working Heart preparations) and tissue preparations (Organ Bath and Wire Myography), blood pressure and ventricular pressure-volume use PowerLab data acquisition systems.
Using the MLS330/6 GLP Client and MLS335/6 GLP Server software, the GLP and 21 CFR Part 11 environment provided by ADInstruments recognizes 3 roles:
- System Administrator - A person or group of individuals, responsible for the configuration of the computer networks within a laboratory. They are responsible for installing and maintaining the GLP software.
- LabChart User - Scientist, researcher or principal investigator who is primarily interested in using LabChart and PowerLab to record and analyze data.
- Laboratory Administrator - Usually the Head of Laboratory or Department and is responsible for authorizing any new user to the GLP system and to upload the corresponding certificates into the system.
CertificatesA certificate is an electronic file which is unique, thereby acting as an electronic signature for a SINGLE authorized user. This electronic identification ensures that the authorized certificate holder did, in fact, access, modify and/or save the file.
Each certificate consists of both a public and private key. To use the GLP Client for LabChart the customers must install a full certificate on their computer so that they can digitally sign documents. In addition, the public certificate must be installed on the GLP Server by the Laboratory Administrator so that the GLP system recognizes the client computer. The client computer must also have a root certificate from the certificate issuing authority installed on it. Root certificates provide evidence that the individual user certificate was created by a trusted organization.
Certificates may be obtained from several different places including: - The ADInstruments website: www.adinstruments.com/certificates
- A third-party issuing authority such as Verisign or Thawte provided that the security level of the certificate is acceptable to your organization.
Obtaining a Certificate - The LabChart User applies for the certificates online using the ADInstruments website
- The Laboratory Administrator will be notified of the application by email.
- The Laboratory Administrator checks and approves the application online using the ADInstruments website.
- The LabChart User will be notified of the approval by email.
- The LabChart User downloads the public and private certificates from the website.
- The Laboratory Administrator notes that the certificates have been successfully downloaded.
Installing Certificates - The LabChart User installs the Full (Private) Certificate via the LabChart software
- The LabChart User installs the Root Certificate
- The Laboratory Administrator installs the Public Certificate
Using the GLP Configuration Utility - The Laboratory Administrator adds the LabChart User and the corresponding certificate
- The Laboratory Administrator configures the properties of the certificate such as the valid duration of the certificate
Training and CertificationADInstruments understands that introducing a GLP system can present challenges. With this in mind we provide on-site installation, training and user certification services.
Calibration ServiceADInstruments can provide periodic calibration for your PowerLab hardware to confirm the system is working within specifications. Calibration can be organized within your GLP time frame and includes a calibration certificate.
Whilst, our GLP software addresses the technical requirements imposed by 21 CFR Part 11, individual laboratories must also implement staff training, operating and administration procedures to ensure completion of the process.
LabChartLabChart software (for Windows and Macintosh) combines the familiar simplicity of a traditional strip chart recorder with the powerful analysis features of a digital acquisition system. LabChart software and a PowerLab data acquisition unit provide data integrity, easy selection of hardware settings, powerful online and offline analysis, procedure automation, seamless extraction of experimental data and flexible display options. Acquisition and analysis capabilities can be further increased with
LabChart Extensions and
LabChart Modules. LabChart Modules are available as part of
LabChart Pro and LabChart Extensions are free for download from the website for existing LabChart users.
GLP (Good Laboratory Practice) Client and Server (Windows)The
GLP Client and the GLP Server software provide PowerLab users with an easy and reliable data acquisition solution for a GLP and 21 CFR Part 11 compliant environment. The GLP Client requires the GLP Server software to operate; however, these programs are provided individually to suit the network configurations of each laboratory. One copy of the GLP Client (MLS330/6) is required for each PowerLab system (per client computer). A single copy of the GLP Server software (MLS335/6) may be used to run an unlimited number of client computers and includes 10 user certificates. Additional GLP Certificates (MLS336) can be purchased from ADInstruments in packs of 10.
The MLS330/6 GLP Client provides the user interface, audit trail and signing components required to meet Laboratory GLP and 21 CFR Part 11 requirements.
GLP Client features include:
- Secure signed data files based on public key-private key encryption to avoid tampering
- A non-editable audit trail recording file operations
- Exportable and printable audit trail (.xml, .php and .txt formats)
- Preservation of raw data
- Data and audit trail in a single file
- Visual indication of file validity
- Date and time stamping
The MLS335/6 GLP Server software provides:
- A centralized user authorization system
- Users with the authority to sign files upon saving
- Verification of signature validity when files are opened
- Access to remote configuration
- Supports an unlimited number of users (with appropriate certification)
- Extensive and customizable logging
- Underlying configuration file suitable for scripting and automating batch processing tasks
ML515 GLP Validation UnitThis test unit is an independent signal generator and is used for testing any research PowerLab. It includes all cables, LabChart Settings Files and Excel diagnostic spreadsheet/reports as well as a user manual describing the testing procedures.
Note: Microsoft Excel is required and is
NOT supplied by ADInstruments.