Instrument Interfacing for the Pharmaceutical Industry
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Overview
Meeting regulatory compliance requirements, decreasing the time to market for new products and upholding the highest standards of quality are key objectives for any pharmaceutical company. In an increasingly competitive industry, how well a company achieves these objectives can be critical to their on-going success.
In this paper, we will review how the design, flexibility and security of LimsLink and LimsLinkCDS can assist pharmaceutical companies in achieving increased efficiency, productivity and security in their laboratories.
Meet Regulatory Compliance Requirements
The following review of the security features included in LimsLink and LimsLinkCDS finds all of the components required to assist in compliance with 21 CFR Part 11.
Electronic Signatures
An E-signature option can be configured to challenge the user to re-validate their identity before selected operations are carried out. All challenges and their responses, successful or not, are automatically recorded in the Audit Trail.
Password Protection
100 levels of password protection control user access to menus, setups, editing and calculations. The password protection component contains the necessary elements to make this a valuable component of compliance with the requirements of 21 CFR Part 11 and to minimize the overhead for administration of this security component.
• Password aging
• Password history checking
• Minimum password length
• User lockouts
• Multiple logon denial
• Workstation lock on X failed attempts
• E-mail notification of lockouts and other security violations
• Centralized password administration
Audit Trail
The audit trail records, to a secure independent database, all significant actions within the program. The original data is always recorded, along with when the change was made, who made the change and a comment explaining why the change was made.
Archiving
LimsLinkCDS and LimsLink’s archiving function employ a database model that includes the raw data, the method used to create the original worksheet and any associated audit trail information. This allows for complete re-construction of any worksheet, without relying on the existence of additional files on the local system.
Protection Against Workstation or Network Failure
LimsLink and LimsLinkCDS can serve as a buffer between your instrument systems and LIMS by continuing to collect and process data from the instrument, even if your computer network or main database is not operating. In the event of a failure at the LimsLink and LimsLinkCDS workstation, all data that was acquired prior to the failure will be recovered.
Secure Application Launcher (SAL)
As a unique feature of LimsLink, SAL works in conjunction with Windows® NT/2000 to increase system security by allowing a user to launch an application without having access to the actual application files.
Labtronics Inc. has an on-going commitment to ensure that LimsLink and LimsLinkCDS provide a secure environment for instrument data and include the components needed to comply with regulatory requirements such as 21 CFR Part 11.
Validation Toolkit
A complete instrument interfacing method communicates with both the LIMS and the instrumentation, building sequence files, applying additional calculations, checking data to ensure it is within limits and combining data from different instruments into one report. It is essential to be able to confirm that every step in the data capture and transfer process is being carried out with accuracy and consistency.
The Validation Toolkit is a software tool that ensures the integrity of your data by providing on-going verification of Installation and Operational Qualification of workstation installations and instrument interfacing methods. The Toolkit is able to compare the LimsLink/LimsLinkCDS installation against all known configurations, confirm that the installation is processing data as expected and ensure that the methods are still managing data in the same manner as when they were originally designed.
In an industry that is increasingly aware of validation requirements through 21 CFR Part 11, ISO certification and implementation of GLP/GMP Standards, the Validation Toolkit is an essential component in ensuring the integrity of your automated data transfer.
Development Procedures that Meet Industry Standards
Labtronics Inc. maintains a documented process for development of specifications, development of software code, quality control and testing procedures. Labtronics Product Development Procedures have been audited by pharmaceutical companies and found to meet or exceed the industry standards required when operating under FDA regulation.
A Standard Solution – in Your Laboratory and in Your Industry
LimsLink and LimsLinkCDS provide a standard, configurable, instrument interfacing solution that can be deployed throughout the laboratory or enterprise. Using one solution for all of your instrumentation reduces the time and cost of implementation and maintenance, reduces training requirements and reduces validation requirements.
LimsLink and LimsLinkCDS are already standards in laboratories worldwide. Since the introduction of LimsLink in 1994. LimsLink and LimsLinkCDS have been adopted as the interfacing solutions of choice. As the industry leader, Labtronics is able to continuously develop and enhance LimsLink and LimsLinkCDS in partnership with many of the leading software and hardware companies in the world. Our many partnerships include:
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Agilent Technologies |
Mettler-Toledo |
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Applied Biosystems |
NuGenesis Technologies |
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Beckman Coulter |
PerkinElmer Instruments |
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Dionex Corporation |
Scientific Software |
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LabVantage |
Waters Corporation |
Our partnerships with the leading software developers and instrument manufacturers are your assurance of an interfacing solution that meets your needs and requirements.
Experience with Your Instruments and Applications
There is a core group of instruments, instrument data systems and applications that are common to laboratories in the pharmaceutical industry. Over the years, Labtronics has implemented LimsLink and LimsLinkCDS to fully meet the requirements of these applications.
Instruments
Gas chromatography, LC, GC/MS, UV Vis, balances
Instrument Data Systems
ChemStation Plus, Chromeleon, Turbochrom/TotalChrom, Millennium32/Empower, EZChrom Elite
LIMS and Knowledge Management Systems
SQL*LIMS, LabManager LIMS, LabManager iLIMS, LabVantage, CyberLAB, NuGenesis SDMS, WinLIMS
Applications
Content uniformity, final product assay, dissolution, raw material impurities, loss on drying, etc.
Interface with Knowledge Management Systems
Many pharmaceutical laboratories employ both a LIMS and a knowledge management system such as NuGenesis SDMSTM , CyberLABTM from Scientific Software or eRecord ManagerTM , from Thermo LabSystems. LimsLink and LimsLinkCDS can play a pivotal role in ensuring that instrument data and sample information is accurately and efficiently managed between LIMS and knowledge management systems.
Many laboratory instruments, such as balances and pH meters, do not have any type of data system associated with them and are therefore incapable of printing reports to the network. This limits their ability to interface to knowledge management systems.
If these instruments are capable of RS232 output, LimsLink can be used to collect their raw data and act as the instrument’s “data system”. The raw data can be linked to the appropriate sample information, additional calculations can be performed, results can also be combined with other results, etc. LimsLink is able to deliver a report to both the knowledge management system and the LIMS in a format that makes the raw data meaningful and relevant for the lab.
Where a laboratory utilizes a knowledge management system to capture reports directly from instrument data systems, LimsLink can play an essential role in managing the transfer of sample information from the LIMS to the instrument data system. LimsLink can also be employed to transfer the data that resides in the knowledge management system over to the LIMS.
Enhance the value of your knowledge management system by including data from all of your lab instruments.
Configurable Interfaces – See the Data that You Need to See
A LimsLink or LimsLinkCDS configurable display presents the analyst with three principal components, which provide of the information needed for efficient management of instrument data:
1. Raw Data Display
The Raw Data display allows the analyst to view the data exactly as it is generated by the instrument, which cannot be edited. In keeping with regulatory requirements, LimsLink automatically saves the raw data and makes it available for future reference. The LimsLink split and parse components provide a graphical based interface for splitting the raw data into single sample components and then extracting the relevant data for each sample. A drag and drop technique is used to highlight the required data from each sample and transfer it to the Single Sample Spreadsheet.
2. Single Sample Spreadsheet
A Single Sample Spreadsheet (SSS) is created for each and every sample that is contained in the raw data. Within the SSS, sample data from other instruments or tests can be combined with the instrument data, additional calculations such as averaging or correction factors can be performed and analyst’s comments or observations can be added to supplement the instrument data. Special Functions can also be called to meet virtually any additional data calculation or reformatting requirements.
3. WorkSheet
The Worksheet display is what the analyst will most often work with. It is a configurable display in a spreadsheet format, where each row is a summary of information for a single sample. This information can include results, calculated values, messages, flags, in short any of the “at a glance” information that will assist the analyst in managing the instrument data. The information in the worksheet display is linked directly from the SSS for that sample. At any time the analyst can drill down from a single line in the worksheet display to see all of the detailed information about that sample.
LimsLink and LimsLinkCDS instrument interfaces provide analysts with the information that they need, when they need it.
Manage Data Flow to Meet Your Needs
Different applications will require varying levels of analyst interaction with the data. In some cases, the data will simply be sent to the LIMS as quickly as possible. In other instances, there will be a need for the analyst to review and approve the data before it is committed to the LIMS.
LimsLink and LimsLinkCDS can be set up to run as a background application – collecting, parsing and reporting data with minimal intervention. Or, they can act as the hub of a data management system, directing and controlling the flow of data between the LIMS and the instruments.
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Worklists can be downloaded from the LIMS and uploaded to the instrument or instrument data system. |
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Additional calculations can be performed on the data. |
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Data from different instruments can be combined together. |
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Results can be reviewed and verified before being posted to the LIMS. |
The configurable display allows you to customize the information that is displayed on the screen and how it is presented to the analyst. For example, if the automated Limit Checking is implemented, the LimsLink display screen can be configured to highlight samples that are found to be outside of limits. This allows analysts to quickly identify and resolve potential problems.
LimsLink and LimsLinkCDS interfaces can be configured to provide full review and approval of the data before it goes to the LIMS or to transfer data directly to the LIMS with minimal analyst intervention. The choice is yours.
Labtronics Services and Support
Labtronics Applications Group is a select group of computer professionals with a background in science and laboratory work. They are available to act as your “instrument interfacing experts” providing a wide-range of services for LimsLink and LimsLinkCDS users.
Consultation
A Labtronics Application Specialist can assist in planning a successful implementation process through developing specifications, review and providing an estimate for a given project.
Implementation and Project Management
Implementation needs and resources are going to vary greatly from laboratory to laboratory. The availability of personnel and the time frame for implementation will determine whether a lab takes full ownership of the implementation process or decides to work in partnership with Labtronics on the project.
Our Applications Group is available to work with our clients at any level in order to ensure successful and timely implementation.
Support
Our Applications Group provides technical assistance and support to LimsLink and LimsLinkCDS users. The first year of our Annual Support Plan, which includes software upgrades, is included with the purchase of LimsLink/LimsLinkCDS
You can be confident that your LIMS interfacing is being implemented and supported by experienced personnel who understand your requirements
North America • Labtronics Inc. • Tel: (519) 767-1061 • Fax: (519) 836-4431 • E-mail: info@labtronics.com
Europe • Labtronics B.V. • Tel: + 31 (0) 182 551243 • Fax: + 31 (0) 182 551270 • E-mail: EuroInfo@labtronics.com
“Reprinted with permission from Labtronics Connections, March 2004. Labtronics Connections is a monthly email newsletter that provides case studies, articles and application notes related to laboratory instrument interfacing. Published by Labtronics Inc., www.labtronics.com“
