November 13, 2019 - Reducing the Cost of Computer Systems Validation Efforts Through Risk Assessment
Computerized systems have been widely adopted by the pharmaceutical industry and are frequently used for instrument control and data evaluation, documentation, transmission and archiving in laboratories. The FDA requires that all computer systems in regulated environments be validated in a documented process known as computer system validation (CSV). CSV serves to verify that a computerized system does exactly what it is designed to do in a consistent and reproducible manner.
For regulatory compliance purposes, CSV confirms the accuracy and integrity of data created, modified, archived, retrieved and transmitted by a computer system in order to ensure product safety and effectiveness. Computer system validation is required when configuring a new system or making a change in a validated system (upgrades, patches, extensions, etc.).
Depending on the complexity and functionality of computer systems, CSV can be a significant undertaking. Pharmaceutical companies have even been known to delay upgrading applications to avoid the validation effort required. In this blog, we will provide some tips on performing a risk-based CSV in order to dramatically lower the costs of validation efforts.
Change is clearly a dominant theme in the 21st century. With modern trends like the digital revolution, globalization, talent shortages, greater workforce mobility, and a multigenerational workforce, long-established business models are facing disruption on many different fronts, and companies seeking to maintain competitive advantage must be more agile and flexible than ever before.
One of the keys to business success in today’s volatile economic environment is attracting and retaining the best talent. As such, industry leading organizations are recognizing the importance of the role of HR leaders to their continued success. Once known for simply managing traditional personnel and administrative tasks, roles for Chief Human Resources Officers (CHROs) are evolving beyond siloed people initiatives.
The BIOVIA ELN is a crucial technology that works with Pipeline Pilot in a seamless fashion. Modern laboratory technologies such as Electronic Laboratory Notebooks (ELNs) and LIMS have made enormous amounts of data available to scientists in life science laboratories. Scientists that are recording, managing and archiving research data in paper notebooks and performing tasks manually simply cannot keep up with this deluge of data. These paper-based methods lead to scenarios where much collected data is siloed and never analyzed, while many experiments end up being needlessly repeated.
Globalization and outsourcing trends, along with technological advancements that have dramatically increased the volume, complexity and variety of data, have created significant data management challenges for modern scientific laboratories. Most laboratories have responded to these challenges by implementing a Laboratory Information Management System (LIMS) that automates business processes and data capture associated with laboratory workflows. With these systems comes vast amounts of data. Ensuring you are managing your LIMS Master Data properly begins with understanding the key terms
LIMS implementations usually demand a substantial investment of time, money and resources, typically costing hundreds of thousands to millions of dollars and requiring hundreds of person days to accomplish. Failure of a LIMS project can be a huge waste of time and resources, and a financial disaster for the organization involved. As such, it is critical to get a LIMS implementation right the first time in order to preserve your return on investment.
One important facet of any successful LIMS implementation and/or migration is the design and configuration of master data. In our experience, many companies involved in LIMS implementations tend to focus on software testing and configuration and put off dealing with master data until the end of the project. This is a huge mistake. Master data design and configuration is typically a much bigger job than anticipated and has multimillion-dollar impacts down the road on things like operational efficiency, time to market and LIMS return on investment (ROI).
The booming economy and record low unemployment in the United States has many companies struggling to attract needed talent amid tight labor pools. In addition to this talent shortage, the digital age has engendered greater workforce mobility. Using websites like Glassdoor, LinkedIn, Facebook, and others, employees can now easily become aware of other opportunities and find a job that better aligns with their values, goals and interests.
A new survey from CareerBuilder revealed that, while 50% of workers feel like they have a long-term career at their current company, the other half feel like they just have jobs. A surprising 32% of survey respondents plan to change their jobs this year. A recent Labor Department report confirmed that these employees are in fact following through on their intentions – the number of employees voluntarily leaving their jobs is at the highest rate it’s been since 2001. To keep pace with technological advances and remain competitive, companies require an experienced workforce with institutional knowledge to maximize productivity and operational efficiency. Given these trends, employee engagement and retention have emerged as top issues for business leaders.
In the last decade, there has been a paradigm shift in the development of gene sequencing diagnostics. This revolution has occurred mainly due to the development of ultra-high throughput next-generation sequencing (NGS) technology that allows a human genome to be sequenced in just a few days. Combined with clinical data, readily accessible genomic data is also accelerating the development of personalized, targeted treatments in a medical model known as Precision Medicine. The UK Biobank Project is on the forefront of this initiative.
In order to develop the genetic diagnostics and personalized treatments characteristic of Precision Medicine, scientists must sift through and effectively analyze immense data sets. This necessity has led to the rapid growth of a new engineering field known as bioinformatics – an interdisciplinary field of scientific research that utilizes biology, computer science, data engineering, mathematics and statistics to increase our understanding of biological processes. Bioinformatics has played a major supportive role in the emergence and continued development of precision medicine.
Bioinformatics scientists need access to the health and genetics data of large cohorts so that the influence of genetics on disease states can be sussed out and incorporated into tailored treatments. In order to facilitate access to the large amounts of biological and health data that bioinformatics scientists need, many nations have launched biobank projects, including the United States, United Kingdom, China, Austria, Qatar, Estonia, Japan, Canada and Finland.
The United Kingdom’s Biobank (UKB) project recently released a vast collection of genetic data to health researchers around the world, offering an unparalleled resource to enhance our understanding of human biology and aid in the advancement of precision medicine. In this blog, we will discuss the types of data made available by the UK Biobank project, along with the details on how scientists can access this important data.
We are pleased to announce that renowned solution provider of the scientific sector, Target Analysis, will be adding QLIMS to their product portfolio and be our new sales distributor in Greece.
Adding QLIMS to their portfolio fits in with their vision to provide quality services that will highlight Target Analysis SA as a Total Solution Provider for the supply and after sales support of scientific equipment and software.
Their product range includes: pre-owned systems, analytical instruments, consumables & spare parts, laboratory equipment, software, solvents & chemicals, by a wide network of internationally recognized manufacturers.
In conjunction with ELBIS’s establishment of the QLIMS support centre in Thessaloniki, this partnership now puts Greek laboratories in the unique position of having local access to:
- a highly trained sales team – Target Analysis
- a quality LIMS solution available in Greek – QLIMS
- local support and technical service – ELBIS
As part of its mission to ensure public safety, the FDA inspects manufacturers or processors of FDA-regulated products to verify that they comply with relevant regulations. The FDA also inspects facilities that conduct clinical trials with humans and laboratories that conduct studies with animals or microorganisms when these studies are used to apply for FDA approval of a medical product. A typical inspection will last for 2-3 days.
In the United States, the FDA is not required to provide advance notice of an inspection. In facilities where violations were noted during a previous inspection, the FDA will likely provide no advance notice. If your last inspection was without violation or if this is a pre-approval visit, however, you will likely be given notice of an impending inspection.
There are few events that engender as much anxiety for company stakeholders as an FDA audit. Are you prepared for when the FDA shows up at your front door? Do your employees know how to interact with FDA inspectors when they are on site? Do you have Standard Operating Procedures (SOPs) in place for handling an FDA audit?
Surviving an FDA audit can be significantly less daunting if you know what to expect and have a strategy in place to ensure the best possible outcome. In this blog, we will provide best practice guidelines to help you prepare for an FDA inspection, as well as understand how to best interact with the inspector – both while they are on site and post-inspection.
OnQ Software and ELBIS are proud to announce the opening of the new QLIMS European support centre and LIMS centre of excellence.
The centre will be based in Thessaloniki, Greece at the offices of leading Greek electrical engineering and IoT development company, ELBIS.
We are happy to leverage ELBIS skills and reputation for providing excellent customer support to ensure QLIMS customers have the best experience possible.
The centre of excellence will allow for:
- Provision of support and technical services to European QLIMS customers
- Showcase of next generation technologies and integrations relating to LIMS
In the recent past, scientific laboratories utilized multiple separate informatics systems, lots of paperwork and numerous standardized operating procedures (SOPs) to achieve data integrity and comply with all regulatory requirements and best practices. Improving sample throughput and data integrity in this scenario was challenging, however, as it relied heavily on user intervention, purchase of extra systems or even new hires to be able to handle the extra workload.
With massive increases in data volume over the last decade, and the growing concern from regulatory agencies around data integrity, integration between informatics systems has become a necessity, especially on systems that generate large amounts of data or that are crucial to the overall laboratory data workflow. Two examples of systems that fall into this category are LIMS (Laboratory Information Management System) and CDS (Chromatography Data System).
The 21st century has seen a rapid increase in the pace of technological innovation in life sciences. For example, while the first mapping of the human genome in 2003 took 13 years and 3 billion dollars to accomplish, next-generation sequencing (NGS) technology now can complete the whole genome sequencing in hours for less than $1000, generating terabytes of data in just a single run.
With the digital age now in full swing, technological advancements are quickly changing the landscape for laboratories in the life science industry.
Retiring baby boomers combined with economic growth has resulted in the number of open positions now exceeding the number of people who are unemployed in the United States. In addition, the number of employees quitting their jobs is high – a recent report by the Labor Department put the “quits rate” at the highest it’s been since 2001. This has created significant hiring pressure in many organizations. In a survey of over 350 hiring professionals across 15 different industries, Criteria Corp reports that hiring volume is expected to increase 2.3% from 2018 to 2019.
The bottom line is that competition to hire and retain talent has never been fiercer, leading many organizations to increase HR budgets in an attempt to attract great candidates – Criteria Corp’s survey also revealed a predicted 6.7% increase in HR budgets from 2018 to 2019. Pre-employment tests are one of the many tools organizations are utilizing to develop more predictive accuracy in their recruitment process. According to the Talent Board’s 2016 Candidate Experience Research report, 82 percent of companies are now using some form of pre-employment assessment testing in their hiring process.
September 24, 2019 - Automation in Agriculture Testing Laboratories to Meet Regulatory, Reporting Requirements
- A team of LIMS sales and support experts based in Australia
- A versatile system that can be configured to the needs of any laboratory
- A LIMS solution that is being successfully used in a host of industries, including environmental/water, dairy/farming/veterinary, biobanking, mining/petrochemical, food/viticulture and research/contract laboratories
- A LIMS that can help to meet ISO and NATA requirements
These factors have combined to establish a growing LIMS customer base for Matrix Gemini both in Australia and the wider Australasian region.
September 18, 2019 - Why Strategic Planning is a Critical for Developing an Effective Laboratory Informatics RFP
Data has become ubiquitous in modern scientific laboratories. In order to turn this data into the insights that drive innovation, industry-leading enterprises are investing heavily in laboratory informatics technologies (e.g., LIMS, ELN, SDMS, CDS, advanced analytics, reporting tools, etc.). Given the many different informatics vendors to choose from, however, along with increasing vendor specialization and demands for cloud-based applications, choosing the best system for your unique laboratory is more difficult than ever.
An important part of the technology selection process is the development of a request for proposal (RFP). This document is used to solicit business proposals from a list of potential software vendors via a bidding process. In our experience, many companies make the mistake of developing an RFP without doing the strategic planning necessary to ensure that it asks the right questions.
The Astrix Team has been called upon to fix many an implementation project gone wrong where the problems can be traced back to a poorly designed RFP. In this blog, we will discuss critical best practice recommendations for creating an RFP that will help to establish a solid foundation for a successful implementation project providing maximum business value for your organization.