LabWare provides a world class solution for all aspects of pharmaceutical Quality Control and Quality Assurance testing. This includes comprehensive laboratory automation solutions for finished goods testing including final certificate of analysis production (CofA), raw material testing, in-process batch testing even including the ability to perform automated in-process testing in the manufacturing rooms during production runs, if desired. LabWare LIMS provides comprehensive out of the box solutions for stability study management and environmental monitoring that is applicable to both sterile and aseptic manufacturing facilities. Our solution can drive value from virtually every stage of the QC and QA process because the LabWare system comprehensively manages and tracks all aspects of a product’s quality. Customers report dramatic reductions in product cycle times through the QC laboratory and EM/Micro laboratories, as well as significant reductions in adverse events such as laboratory investigations due to human error. As a result of LabWare’s ability to Review By Exception, laboratories have been able to liberate staff who previously were tied to redundant data checking tasks and move these resources to higher impact areas of the business.
Business analytics, annual product review reporting, SQC and SPC trending, as well as key performance indicators are easily derived from the LabWare ELP, allowing your business to quantitatively measure QC turn-around time, investigations and out of compliance issues, resource and instrument utilization and leverage this information as an asset to capacity plan and optimize your business to achieve maximum operational efficiency.
A key element of LabWare’s global success in the pharmaceutical industry derives from the products purpose built functionality for the Quality Control laboratory as well the product’s ability to support electronic capture of results from all laboratory instruments, and monitoring devices used within your production facilities. Standardizing on LabWare’s strategic platform will give your QA/QC organization the following benefits:
The LabWare ELN (electronic laboratory notebook) product offers paperless method execution for GMP samples being tested by the QC laboratory against SOPs and STMs, with the benefit that LabWare ELN is inherently integrated into LabWare LIMS providing it with seamless access to all quality data, product specifications and control limits, training certifications, instrument calibrations, and standard or solution data that ensures methods are executed by QC analysts correctly the first time. LabWare ELN offers a Compliance View that actively monitors and ascertains the compliance related status of a method as the QC analyst performs each step. Supervisors can be immediately notified when a deviation or adverse event occurs in the lab and provide immediate corrective action so that problems are detected at the source in near real time, rather than later in the process when they are more costly to correct.
- A single strategic platform from for all quality control and assurance activities
- A system to comprehensively manage your product specifications and control limits
- A single global system to institutionalize compliance and measure product quality across all business units and plants
- An end-to-end solution that can consolidate many heterogeneous legacy applications and site-based LIMS into a single global LIMS, thus reducing IT and support costs, while building a long term strategic asset for your business
- Leverage industry best practices through the implementation of LabWare’s pharmaceutical template solutions
Configurable Off The Shelf Software:
One of the most compelling attributes of the LabWare LIMS and ELN solution is its ability to be rapidly tailored through configuration, not customization, to meet your specific needs in the lab as well as institutional requirements like system interfaces to key business software and in-house databases. With over 250 purpose-built software modules that LabWare provides to enhance the LabWare core LIMS and ELN software foundation and allow it to be specialized to meet unique needs, the LabWare platform offers unmatched out of the box functionality in the market. LabWare’s advanced software architecture enables the product suite to be extended without requiring you to move to the next version or to re-validate the system, an overwhelming advantage that most LabWare customers find truly compelling. The real “Game Changing Technology” however is LabWare’s tremendous extensibility through configuration. Configuration allows your organization the freedom to tailor our application to meet your specific needs without worrying that it might affect your support or upgradability.
The LabWare LIMS and ELN platform are fully compliant with all technical controls of industry regulations, such as 21 CFR Part 11 (Electronic Records and Electronic Signatures), GMPs, and regulatory requirements from many international regulatory agencies. The LabWare Platform has an extensive audit trail and can be configured very easily to support your company’s interpretation of audit reason prompting and if appropriate electronic signature.
LabWare’s software is built to interoperate with virtually any type of instrument software, business software, even including custom in-house developed databases and software you have within your organization. We offer out of the box software modules that interface with many common software applications and instrument systems used in the pharmaceutical industry, such as ERP and QMS systems such as SAP and TrackWise, as well as offering a full suite of tools that allow you to create one way or bi-directional interfaces to other systems. LabWare’s adherence to industry standards and open architecture includes Web Services means you will never be locked out from creating point-to-point interface solution or connecting the LabWare platform to an Enterprise Service Bus product to future proof your Quality organization from change and technological advancement.
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