October 16, 2019 - Strategies for Surviving an FDA Audit

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.

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October 9, 2019 - New QLIMS European Support Centre

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

October 9, 2019 - Best Practices for Integrating LIMS with Empower

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).

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October 2, 2019 - Future Proofing Your Lab to Match the Pace of Innovation

The 21^st 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.

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October 2, 2019 - Best Practices for Utilizing Personality Assessments in Hiring

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.

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September 24, 2019 - The best choice for a LIMS in Australia?

Discover how Australian LIMS users can benefit from Matrix Gemini LIMS

There are plenty of reasons why anyone needing a LIMS in Australia should look no further than Matrix Gemini from Autoscribe Informatics. These include:

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.

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September 10, 2019 - Selecting an ELN to Maximize IP Protection

In the race to patent or publish in life sciences, time is critical. For any researcher, securing Intellectual Property (IP) is equally critical. In order to receive a patent on an invention, inventors must be able to document the work they did to prove that the invention substantially performs against the claim. Additionally, this proof must be corroborated by someone (e.g., custodian of records) not directly involved in the work. Effective documentation and corroboration of the work done on an invention is also necessary to protect IP against challenges to the U.S. Patent and Trademark Office (USPTO) and possible litigation from competing inventors.

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September 4, 2019 - Benefits of an ELN in BioPharma

With more and more pressure being put on research and development units to accelerate the drug development process, many organizations are changing the way they operate. Biopharmaceutical companies are collaborating with academia and CROs in the discovery process and looking at new technology to make their process more efficient. One such technology that, when implemented…

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August 21, 2019 - Best Practices for Integrating Laboratory Instruments with Empower

Modern analytical laboratories have experienced massive growth in data volumes over the last decade. In order to meet the challenge of turning this data into knowledge, laboratories are looking to automate and integrate laboratory operations and processes as much as possible in order to enhance data integrity and provide digital continuity throughout the product lifecycle. Integrating laboratory instruments with laboratory systems such as Empower is one of the best ways to drive operational efficiency and enhance data integrity in the laboratory.

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August 21, 2019 - Ask the Consultant: Computer System Validation Advice

Computer System Validation is an essential and complicated task for regulated computer systems.  It can be challenging, which is why learning from each validation performed can help make all future validations easier, with fewer deviations.  This learned experience can only be obtained from executing a validation and not just learning how to perform one. Each…

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August 21, 2019 - Seeing Matrix Gemini Configuration Tools in Action

The Matrix configuration tools set Matrix Gemini apart from other LIMS. We can’t emphasise enough the importance of this approach, because it allows the LIMS to be configured to exactly meet the needs of any laboratory without compromising the ability to support the system or upgrade it in the future. We’d like to show you just how versatile the system is in our recently updated LIMS configuration video series which demonstrates the configuration tools in action. The graphical editor provides a ‘drag and drop’ approach to provide a personalised user interface with no impact on the underlying core code. There are a few extremely important points to remember when watching the video...

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August 14, 2019 - Conforming to TGO 93 Standards with QLIMS

The Narcotic Drugs Amendment Act 2016 saw the rise of the medical cannabis industry in Australia, as it permitted the research, cultivation and production of medical cannabis and related products. Following this, the Therapeutic Goods Administration (TGA) had a new task on their hands, regulating the production/manufacturing of what was once a Schedule 9 (S9) drug. As such, the TGA issued a new standard to specify the minimum quality requirements that unapproved medicinal cannabis products imported into and supplied/manufactured in Australia must adhere/conform to, this came be to be known as TGO 93 (Standard for Medicinal Cannabis). TGO 93 stipulated that any company within Australia looking to import/export/manufacture Medicinal Cannabis products had to adhere to the standard and ensure that the active ingredients and cannabinoids present in the final product are strictly derived from the cannabis plant. As TGO 93 involves recording, tracking and reporting on a range of macroscopic and microscopic examinations as well as chromatographic procedures, handling the data via a paper-based method becomes quite cumbersome and has no reportable audit trail.

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August 14, 2019 - Enhancing Data Integrity in Clinical Research with Blockchain Technology

Verification of data integrity is a critical part of the FDA’s mission to ensure the safety, efficacy and quality of human and veterinary drugs, biological products, and medical devices. As these products must undergo extensive testing before being approved for the public, gathering high-quality, reliable and statistically sound data is an important goal for all clinical research. There are, however, converging trends challenging the ability of legacy data management systems to establish and sustain data integrity throughout all phases of clinical studies...

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