White Paper: MasterControl
Overcoming Pharma’s Top 6 Quality and Compliance Oversights Benefits of Platform Integration and Iterative Task Automation For companies doing business in the heavily regulated pharmaceutical industry, quality management and compliance are not just intimidating endeavors — they involve activities that are increasing in complexity as the industry accelerates. Quality successes can only be achieved in the modern regulatory environment when an extensive range of variables are continually monitored and appropriately handled. The prevention of quality oversights — whether they occur during document control activities, corrective action/preventive action (CAPA) management, audit initiatives, supplier relationships, or any other quality-related process — demands precise actions, informed decision-making, and connected processes, all of which can only be realistically achieved in accordance with regulatory requirements by using purpose-built digital solutions. Avoiding Quality and Compliance Oversights This brief presents six common quality and compliance missteps that pharma companies either inadvertently enable or unknowingly perpetuate over time. It also recommends actions organizations can take today to help mitigate the long-and short-term problems caused by each oversight. Oversight #1: Failure to Adapt to Regulators’ Risk-Based Approach to Quality Over the past decade, the regulations and standards that affect pharmaceutical companies have been trending toward a greater focus on risk management and risk-based thinking, a shift that has undoubtedly been accelerated by the COVID-19 pandemic. With each update to an existing standard or new regulation that goes into effect, regulatory agencies are placing more emphasis on risk management and mitigation. Regulators across the globe are shifting from what was once a one-size-fits-all regulatory mentality to a more segmented approach that is primarily driven by data. This compliance trend is expected to become more prevalent, as indicated by the U.S. Food and Drug Administration (FDA) Q9 Quality Risk Management guidance which specifies that greater assurance of a company’s ability to deal with potential risks “might affect the extent and level of direct regulatory oversight.”i As the role of good quality data (and auditors’ access to it) becomes increasingly vital to the enforcement of regulatory policies, effective risk management is emerging as the cornerstone of compliance. But risk-based quality management isn’t just important for compliance reasons — it is essential for neutralizing the effects (and potential effects) of quality events that commonly occur in pharma environments.
White Paper: Prmaconsulting
Given that it can take up to 12 years and cost £400 mn to £1.15 bn¹ to bring a new drug to market, it is understandable that organizations are capitalizing on the benefits of new technologies to try to reduce uncertainty, costs, and time to market. For many leading companies, digital applications are informing direction and becoming an essential enabler in realizing their vision. So why are digital applications transforming the value and access functions? We believe that there are three key benefits for market access. Facilitating proactive planning and agility While companies may already have a market access planning process, digital applications can facilitate a proactive approach by providing a structured checklist of activities and identifying vital gaps mapped against the latest HTA requirements. In addition, tasks can be assigned, alerts raised when items have not been addressed, and progress or completed tasks tracked. This provides confidence that a market access plan can be formulated early, is always current, and can adapted whenever there is a business need to change direction. Improving real-time decision-making and accelerating cross-functional productivity Digital applications and cloud technology can provide a consistent framework for real-time decision-making across the multifunctional groups that feed into market access planning and implementation. From as early as Phase 1 development, market access issues can be captured, the risks and benefits of considerations such as parallel consultation defined, and the requirements for HTA submissions considered. Capturing data in a centralized system provides an institutional memory of decision-making and allows more rapid and efficient cross-functional working.
White Paper: DMLogic
Implementing a Serialization Project Post DSCSA With growing concern surrounding the integrity of the pharmaceutical supply chain, many companies have chosen to implement serialization method to prevent counterfeit drugs from reaching market.To conform with the new DSCSA, manufacturers are making an investment in the systems, equipment and processes to ensure that their drugs are serialized at every stage of the supply chain. The only way to counteract the distribution of falsified medicines is the reliable serialization and labeling systems of pharmaceutical products that can put an end to the very serious global trade in illegal drugs. This whitepaper gives you insights on overcoming the practical challenges of pharmaceutical serialization, best practice deployment and achieving business benefits. Download the guide now to discover: How serialization will address issues in the integrity of the supply chain? How reliable serialization and labeling systems of pharmaceutical products can put an end to the very serious global trade in illegal drugs? Understand how serialization will affect operations? What are the challenges of serialization?
Track and Trace in the Pharmaceutical Industry
White Paper: Gep
The pharmaceutical industry is not short of challenges — patent cliffs, regulatory scrutiny, and R&D productivity, as well as a complex supply chain. Pharmaceutical products see several changes of hands — from the manufacturers to distributors to dispensers and, finally, the patients — allowing easy entry of counterfeit drugs and drug diversions. According to estimates by the WHO, nearly $40 billion is lost each year to counterfeit products.
Epic Fail: Five Proven Ways to Botch Your Supplier Relationship Management Program And Steps You Can Take to Avoid Them and Create Success
White Paper: Gep
Supplier Relationship Management (SRM) is not a new concept, but it has been growing in importance. The theory is that SRM helps enterprises drive value in both recessionary periods – like that of the last few years – by enabling cost reductions, and also in high growth phases by supporting increases in market share. The reality, however, is that very few organizations have seen demonstrable results from SRM programs – very few of these initiatives are truly effective or sustainable, primarily due to poor strategy and execution.
Titration Theory and Practice
White Paper: Mettler Toledo
Titration is the method of analyzing the concentration of an unknown substance in a solution with the help of a titrant of known concentration based on the complete chemical reaction that occurs between the unknown substance and the titrant. It is one of the widely used laboratory technique of quantitative chemical analysis in the fields of chemical, electronic, food and beverage industries. The titration theory is determined by the type of the chemical reaction that occurs in the different titration process which is then monitored through a color indicator or potentiometric principle and a distinction between endpoint and equivalence point is made to establish the concentration of the unknown substance. Key takeaways from this white paper: Titration is a well-established analytic technique with higher precision and accuracy. It also provides good price and performance ratio compared to other techniques. Distinct differences between automated titration and manual titration are established. A complete guide for Karl Fisher’s titration process is provided in details. Detailed understanding of titration components and process.
White Paper: Mettler Toledo
A clean work area leads to better results contributing to a healthier environment. Cleaning imparts a significant effect to both the operator safety as well as minimizing the risk of cross-contamination. A Clean Balance for your laboratory is a first step towards safe and accurate weighing results. It also helps in providing an enhanced shelf-life to your instrument. Engaging into cleaning procedures, not only increases operating reliability, but also, reduces equipment failure rates. Find out more on balance cleaning through the Whitepaper below that will help in addressing your concerns: Are my equipments well cleaned, sterilized, decontaminated, or disinfected? Are you using the appropriate cleaning agent for your instrument? What are the standard balance cleaning procedures to be taken?
White Paper: Mettler Toledo
While it is important for researchers to choose the most appropriate type and volume range of pipettes, it is equally important to establish a regular pipette testing program to confirm that performance remains within the specified limits, supported by preventive maintenance and calibration if necessary. The more frequent pipette performance tests, the sooner defective pipettes will be detected and taken out of service, decreasing the risk of incorrect results and helping to minimize the need for corrective action. For assuring pipette performance, organizations have to follow essential requirements of a pipette care, maintenance plan, regulatory scheduled testing, and maintenance. What is the use of pipette maintenance? What is the impact of pipette performance testing? What is the future of pipette performance management and storage of pipettes? Move ahead and read the following white paper that will address all your questions, including these: What are the various types of pipettes? What are the best practices for pipette performance management and pipette performance assurance? What are the different testing, calibration, and preventive maintenance for pipettes? How to find a good service provider and manage the full service cycle?
White Paper: Mettler Toledo
A pipette being the most important of all equipments in a laboratory requires to be well chosen. The pipetting system helps researchers to make informed choices on various equipments for calibration and routine operations. Choosing the right pipette helps in achieving accurate results. Dosing small volumes of liquid into different apparatuses can be tiresome at times, and is practiced on daily basis for research purposes. Thus, it is essential to use high-quality pipettes and controllers for increased level of productivity, and reducing person-hours at laboratories. Read a detailed guideline on Pipetting Systems with the White paper published below to address your concerns: Does your current pipette equipment give results with precision and consuming less time? How does pipetting techniques and use of good quality pipettes made from PVDF polymers enhance your result accuracy? Is the right pipette chosen for conducting the research study?
White Paper: Mettler Toledo
The understanding of behavior process of weighing devices is known as calibration. A weighing instrument can be calibrated without making adjustments. Calibration certificates have passed and failed sections to determine whether a measurement device is working ‘well enough’ with the help of tolerance. Standards weights are defined for particular units as test weight. The relationship between the known value and the measured value helps in understanding the behavior of the weighing instrument. Key takeaways from this white paper: Calibration is not the same as an adjustment. The calibration process can be done without adjustments. Tolerance is gathered from a variety of sources and the correct tolerance does not exist. Measurement uncertainty determines the difference between actual value and the measured value. Calculation of measurement uncertainties helps in determining the minimum weight. The relative measurement uncertainty is smaller than the weighing tolerance requirement during weighing more than the minimum weight.
Considerations for Modernizing Scientific Compute Research Platforms
White Paper: Avere Systems
Present life sciences research organizations deals with petabytes of data which requires new performance and data management for IT infrastructures and storage solutions. To address the performance and data management issues found in life sciences organizations, a high performance hybrid file system is used which stores data closets to compute resources that can modernize infrastructure and enable discovery. The whitepaper addresses the following questions: What are the considerations for modernizing scientific compute research platforms? What is the impact of infrastructure issues on research and discovery projects? What changes have greatest impact on infrastructure? What are the characteristics of a modern research environment infrastructure? What is the need for adopting a high performance hybrid file system?
Orchestrated Customer Engagement: Build customer trust and loyalty through more effective engagement
White Paper: IMS Health
Orchestrated Customer Engagement (OCE) has now proven itself to be the next generation of customer engagement beyond Multichannel Marketing and Omni-channel Marketing. Orchestrated Customer Engagement is an innovative strategy that helps life sciences companies align their sales and marketing functions, integrate customer-engagement activities across the organization, and support it all with a foundation of robust information management. This whitepaper discusses how companies can orchestrate customer engagement. Key takeaways from this whitepaper: Illustration showing comparison between how Life Sciences companies interact with their customers before and after implementing Orchestrated Customer Engagement Why do Life Sciences companies need Orchestrated Customer Engagement? Key ways in which Orchestrated Customer Engagement helps organizations address several challenges How Orchestrated Customer Engagement works: A use case scenario
White Paper: Iptor Supply Chain Systems
To say competition in the pharmaceutical industry is fierce would be an understatement as the current trends in healthcare demands more from the supply chain partners. There is a pressing need for a more powerful, intuitive enterprise pharma solution. The pharma solutions are not only presented in response to current trends generally, but are also practical, affordable and available now. This whitepaper discusses the following four key pillars necessary to ensure competitive relevance in the pharmaceutical industry over the following five years: An intuitive enterprise solution for a pharma distribution center A reliable ordering process that hit pharma DCs every business day Specialized warehouse capabilities to rapidly respond to changing global pharmaceutical emergencies End-to-end track-and-trace technology along the supply chain
White Paper: IDBS
Knowledge is among the most valuable strategic assets in the life science organizations today. Exploiting the research information to effectively turn it into knowledge is crucial in the competitive environment of life sciences industry. Electronic Lab Notebooks (ELNs) offer an effective knowledge capture and data management solution for today’s information-rich laboratories. But how maximum value can be extracted from a life sciences organization’s primary asset – knowledge? This whitepaper provides the organizations with secure knowledge management that can be accessed and shared with ease. It includes: Capture, protect and exploit corporate knowledge Increasing efficiency and productivity with ELNs Return on Investment (ROI) of an ELN It also fulfils each researcher’s requirements of an Electronic Lab Notebooks in one application, minimizing IT support and protecting corporate knowledge in a fully compliant environment.
White Paper: SHYFT Analytics, Inc.
Why Real World Evidence (RWE) is important to drive improvements in patient outcomes? Real World Evidence (RWE) has long been heralded as a “game changer” for the life sciences industry. Real World Evidence is the term used to describe research findings that use data that is gathered outside of standard clinical trials. This informative whitepaper highlights the growth, importance and benefits of Real World Evidence data to the pharma industry.It addresses the questions such as: Why Real World Evidence (RWE) is an important driver of decision-making in healthcare? How does Real World Evidence analytics accelerate the Improved patient Journey and descision making ? What are some of the main challenges in establishing Real World Evidence programs? What are the ongoing data challenges and unrealized opportunities when it comes to Real World Evidence data? What are the steps taken by the organizations in order to standardize the collection and structure of Real World Evidence data?
White Paper: Scientific Technologies Corporation
The state immunization registry, or immunization information system (IIS), is an important resource for consolidated patient immunization records so that vaccination providers can access this information.Over the years state immunization registry have evolved into sophisticated data management and clinical decision support tools for vaccination providers. Read this informative whitepaper that brings you the best practices to improve vaccination rates and quality of care in retail pharmacies through state immunization registry.It addresses below questions : What are the biggest barriers to provide immunization services in community practice? Why the retail-based pharmacist vaccinators have not taken up using the IIS as part of their daily pharmacy vaccination workflow? Did having the registry information provide a positive return on investment in terms of benefits gained? How using the registry impact the vaccination rates for the patients receiving pharmacy immunizations? How to take advantage of an immunization information programs to increase vaccination rates? What steps do private companies take to increase vaccination rates and why? Download this whitepaper to learn how to make immunization registry the best possible way to improve Vaccination Rates and Quality of Care in Retail Pharmacies
White Paper: Pacific Biomarkers
Biomarkers for the prediction of acute kidney injury: A review on current status and future challenges Biomarker of acute kidney injury (AKI) is strongly associated with increased morbidity and mortality in critically ill patients. The approach to analyzing AKI biomarkers has been to provide pharmaceutical and biotech companies with services for testing robust novel biomarkers that have undergone thorough analytical validation and clinical qualification with the expectation to diagnose early organ injury. Read this insightful whitepaper on ''Biomarkers for early detection of acute kidney injury'' to know more on: How to target biomarkers that can detect acute kidney injury (AKI) and what the potential of an AKI biomarker program is. What are the issues surrounding the best methods of collecting and storing urine used for detection of AKI in human subjects? Acute kidney injury biomarkers performance assesment
White Paper: Pacific Biomarkers
Testing for incretins, and other gut hormones, presents numerous challenges because of their instability. Therefore, proper sample collection and meticulous pre-analytical and analytical sample handling are crucial for successful quantification of these biomarkers. Incretins, which are insulinotropic gastrointestinal hormones, are produced mainly in K and L cells of the small intestine under the influence of nutritional stimuli. This insightful whitepaper sees into queries like: What are the significant challenges in the measurement of incretins and gut hormones? What is the best practice for minimizing pre-analytical variability associated with blood collection, processing and storage? What are the additional pre-analytical steps that should be considered when samples are obtained for quantification of active acylated ghrelin? Download this whitepaper that provides insights about the challenges, best practices and major concerns regarding commercial assays for reliable quantification of incretins and gut hormones and specific pre-analytical and analytical processes as well as data analysis to improve sensitivity.
Preanalytical Considerations in the Design of Clinical Trials and Epidemiological Studies
White Paper: Pacific Biomarkers
Preanalytical considerations in the design of clinical trials and epidemiologic studies are the cornerstones of the biochemical analyses. The main subject of clinical study design and epidemiology research is to monitor health, detect the harmful side effects and study the impact of therapeutic interventions. However, the largest contribution of errors in the clinical study design and epidemiology is associated with preanalytical phase. Do you think preanalytical variables are given sufficient consideration when designing clinical trials or epidemiologic studies? What strategies can be used to minimize preanalytical variables in clinical trials or epidemiologic studies? Is there a technology or a process to improve stability of sample analytes so that future investigations will not suffer from poor sample quality? What are the common challenges encountered during the preanalytical phase? This whitepaper discusses the factors to be considered during clinical trial designing and challenges faced during preanalytical phase such as: Availability of limited resources during the clinical designing. Technology and storage processes used to store the biomarker samples. Time elapsed between the sample collection and the stabilizing agents used to store the samples. Download this whitepaper with a brief insight into the issues of preanalytical variables and how they impact the clinical trial design and epidemiologic studies.
Integrating FDA GLP Compliant Capabilities into a CAP/Clinical Trials Production Laboratory: An Alternate Approach
White Paper: Pacific Biomarkers
Good Laboratory Practices (GLP): In order to enhance patient safety and improve the quality of testing performed in laboratories, there is a need for integrating good laboratory practices. There are many areas and processes that a laboratory should consider before adding waived testing to the panel of services. Incorporating FDA GLP capabilities into CAP/clinical facility poses certain challenges. Starting a FDA GLP compliant facility from scratch or bringing FDA GLP compliant capabilities into a facility that is already established under a different set of regulations or practices is challenging. So what are the common challenges in implementing regulations for good laboratory practices and how can they be overcome? Read this whitepaper to know about the common queries on more advanced topics related to integrating good laboratory practice. How can we incorporate CAP and FDA GLP compliant testing in the same space? What are the models used by a facility for incorporating FDA GLP capabilities into its CAP / clinical facility? What are the activities associated with good laboratory practices? Download this whitepaper now to learn more about FDA GLP and CAP regulations for integrating good laboratory practices in your clinical facility.
Improving Your Company's Efficiency and Effectiveness, No Matter its Size
White Paper: SAP BusinessObjects
Your company’s focus has been on streamlining operations, acquiring customers, increasing revenues and profitability, and outpacing the competition. And while your company has continued to improve its operating efficiencies (sometimes by quickly learning from past mistakes), you feel your company should be spending more time analyzing what’s going on and predicting and planning for the future – rather than having your employees constantly running around trying to solve operational problems based on history and putting out fires.
White Paper: DATUM
Viral content is contagious and the persuasion of viral marketing has an enormously strong pull.The goal of viral marketing is to create vcontent that goes viral and it spreads quickly via social media and is viewed, read and shared hundreds or thousands of times. But does creating viral content can benefit your products and services? Will the audience enjoy a little bit of purposeful viral marketing? Focusing on creating highly valuable and useful content that caters to audience’s needs should be main goal. When it comes to viral content and marketing, the ability to gauge your audience is extremely important. This white-paper focus on highlighting some truths about the anatomy of viral content including the topics such as: Setting the realistic goals and reasons for creating a viral content What’s the difference between viral marketing and viral content? Why Viral Marketing can be dishonest? Does viral content provide more value to the customers?