Increasing the Success of Your Pharmaceutical Laboratory with LIMS Solutions

A purpose-built LIMS, which has the option to embed LES, ELN and other modules, leap-frogs the lengthy customization process. Since industry workflows and operating procedures determine functionality, platforms are configured to meet needs before implementation processes are even started. This accelerated start has numerous and notable advantages.

1. Save Time

Compared to a more typical LIMS system, a pre-configured LIMS can deploy up to 75% faster. Its purposeful functionality reinforces a consistent, industry-standard workflow that helps labs to achieve greater productivity and efficiency.

2. Save Money

Significant cost savings can be made from faster deployment and improved functional efficiencies. Replacing stand-alone LES and ELN products and other point solutions with pre-packaged, fully embedded modular capabilities in one streamlined platform helps to maximize return over time.

3. Reduce Risk

A purpose-built LIMS uses industry best practices and the latest compliance and regulatory developments. Therefore, it eliminated the need for custom code and reduced the configuration effort overall. This in turn reduces the risk inherent with other LIMS projects.

4. Stay Focused

In the purpose-built LIMS, lab managers can conceal or disable non-essential functionality. This results in a user experience that is focused to the specific industry as well as the needs and use cases of front-line staff. Therefore, training time is reduced, productivity is increased and overall quality is improved.

5. Future-Proof Business

Industry regulations and conditions change over time. As a result, labs are likely to undergo change as well – with the addition of new service areas, new users or new tests as the business grows. A modular, purpose-built LIMS that uses industry-standard web technology is able to expand with the business, from start-up labs through to global operations. This is all possible without the prohibitive cost, time and compliance issues that come with specialized coding.

Built Better for Pharmaceutical Labs

In an industry under intense scrutiny, compliance begins and ends with the right technology

Compared to many other industries, traceability and compliance guidelines are more stringent for labs in the pharmaceutical industry. This is particularly the case as regulators turn their focus to the question of temporary memory.

WHO updates its position on data integrity in 2014 within its Guidance on Good Data and Record Management Practices report. The FDA and MHRA followed suit shortly after with draft guidance calling for the permanent capture of all data generated, including temporary data. This is in order to satisfy a CGMP requirement.

The writing is on the wall for drug manufacturers reacting to these changes: tighter data integrity standards are here and require new tools, SOPs and training. LabVantage Pharma is the first and only informatics platform that is specifically configured to meet this requirement.

The new data auditing functionality is web-based and joins a suite of built-in features that are already optimized for use in pharmaceutical labs. The implementation time is significantly less than that of other traditional systems because it has been pre-validated following GAMP 5 guidelines and pre-configured for industry-standard testing activities.

The end result is a compliant-ready pharmaceutical LIMS that can be implemented in labs in as little as three months, and that provides accelerated access to advantages including:

Data Auditing Functionality Compliant with Emerging Data Integrity Standards

LabVantage Pharma includes Dynamic Auditing. This is a purpose-built tool designed to help drug manufacturers adhere to existing and proposed data integrity guidelines from the WHO, the MHRA and the FDA. The tool can be used in the lab to capture a complete, clean, GxP-compliant audit trail, including:

  • Changes in temporary memory (entries made before saving data)
  • All changes in data
  • Electronic signatures and mandatory reason for changes
  • Date and time of data entry
  • Identity of person entering the data

Built-In Documentation to Help Validate the System – and Keep it Validated

LabVantage Pharma is the only pharmaceutical LIMS solution currently on the market that provides complete documented evidence of previous validation execution, from user requirements to final system release and IQ/OQ/PQ.

Labs can save money in two ways because it comes pre-packaged with pharmaceutical-specific functionality. Firstly, they do not need to apply heavy configurations to a generalized system. Secondly, labs do not have to write and execute validation scripts to match those configurations.

Using the GAMP 5 guidelines, the testing and quality team at LabVantage Pharma have already done both. Therefore, labs can smoothly and easily continue the validation exercise as needed, according to their specific processes.

Optional LES to Enforce Consistency and Avoid Expensive Mistakes

The foundation of LabVantage Pharma is the enterprise-level LabVantage LIMS solution. Many of the functions are either turned off or concealed to focus the user experience on activities that are pharmaceutical specific. However, those functions can be added on or reactivated as required.

An example is the LabVantage Laboratory Execution System (LES). It is embedded right inside the platform and gives lab managers a streamlined tool for documenting, enforcing and defining method work steps. Using the LES, analysts can perform tests consistently and according to internal SOPs. This avoids wasted effort or expensive re-runs.

The Accelerated Implementation Experience

Choosing a purpose-built LIMS is similar to strapping a rocket booster to the implementation process. Much of the background work is complete before the process begins, which gives the user a head start without sacrificing performance, consistency or compliance.

The table below demonstrates how the LabVantage implementation process compares to a typical implementation process.

A Typical LIMS Implementation LabVantage LIMS Implementation
Minimum 12 months to deploy Deploys in as few as three months
A massive up-front investment drives this deployment process, which begins with a detailed discovery and documen-tation of user needs and progresses through multiple design iterations and testing phases. Heavily customized and configured systems introduce risk and its corresponding compliance requirements, necessitating a significant investment in validation and test planning.

Once fully customized and compliant, the system is ready for use – but only after a significant investment in training for all users and administrators. Training time-lines are contingent on the complexity of customization and are often a significant factor in typical deployment costs. When updates are required after deploy-ment, the vendor must be involved for specialized customization and/or installa-tion, further adding to the costs and time required to maintain performance.
Because this system is already configured for your industry using established industry best practices, the implementa-tion process is much more efficient. Data templates are integrated and the products and functions most commonly relied upon by industry-specific users are engaged and ready. If further configu-ration is required, the system’s modular design is easily adaptable without code; ongoing updates and enhancements require no specialized skill or outside management.

 

Run a Digital Enterprise with LabVantage

Every successful laboratory functions at the nexus of technology and talent, regardless of the industry. This means having the best, most streamlined tools, used by the right people. LabVantage is the market leader in modern and efficient LIMS solutions and, as such, is essential to that winning formula.

The Best and Most Secure Technology in the Industry

The LIMS is feature-rich and completely web-hosted. This gives network users access to the same information from one easy-to-use, secure system. This is the case whether they are in the same lab or across the world. Hosted in the cloud or on-premise, the system is also able to connect labs with third-party contributors outside of their firewall, for example research organizations or manufacturing partners. This allows for harmonized data input through a single platform.

A System that Adapts to Changing User Requirements – Without Code

The purpose-built LIMS has a modular design that invites further adaptation and configuration without the need for specialized coding skills. Users can either configure their platform themselves, or rely on the global professional services team from LabVantage to do it. Both these scenarios reduce the effort, complexity and cost of additional testing and compliance.

A Fully Interoperable Experience from Start to Finish

With LabVantage, there are no more siloed informatics systems for individual use cases within a product life cycle. The system interconnects the user processes within a single, central hub. This means that documentation generated during early R&D explorations is consistent throughout manufacturing and final quality assurance testing. Therefore, the lab is more efficient and there are fewer opportunities for risk which leads to an overall stronger business performance.

A Professional Support Team in Lockstep with User Requirements

From deployment through validation and ongoing monitoring, the global professional services team at LabVantage, consisting of business analysts, engineers, and project managers, offers consistent and top-rated support services. LabVantage aims to become a partner rather than a vendor through managed services. For example, the LabVantage team will regularly optimize, monitor, enhance and administrate a user system, which gives the user greater confidence as well as more control over their IT and labor costs.

Conclusion

LabVantage Pharma helps pharmaceutical labs to maintain data integrity standards while also operating efficiently and consistently.

Users can enhance their pharma lab with the full-featured, entirely web-based informatics platform that is specifically designed for success in their industry.

References and Further Reading

1 Gartner, “Hype Cycle for Life Sciences, 2018”, Published 25 July 2018, Analyst(s): Stephen Davies, Michael Shanler, Jeff Smith.

About LabVantage Solutions

LabVantage Solutions, Inc. is the leading global laboratory informatics provider. Our industry-leading LIMS and ELN solution and world-class services are the result of 35+ years of experience in laboratory informatics. LabVantage offers a comprehensive portfolio of products and services that enable companies to innovate faster in the R&D cycle, improve manufactured product quality, achieve accurate recordkeeping and comply with regulatory requirements.

LabVantage is a highly configurable, web-based LIMS/ELN that powers hundreds of laboratories globally, large and small. Built on a platform that is widely recognized as the best in the industry, LabVantage can support hundreds of concurrent users as well as interface with instruments and other enterprise systems. It is the best choice for industries ranging from pharmaceuticals and consumer goods to molecular diagnostics and bio banking. LabVantage domain experts advise customers on best practices and maximize their ROIs by optimizing LIMS implementation with a rapid and successful deployment.

 


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Last updated: Aug 15, 2019 at 8:51 AM

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