Then sustain this effort by making ethics and data integrity a crucial part of your quality system. Send Article (Must Login) Just as peanut butter, jelly and bread go together, so do ethics, data integrity, and quality. It starts with key definitions and then goes on to address critical issues such as inclusion or exclusion of data from decision making process, access control, validation of data, good documentation practices, audit trails, electronic and paper raw data, training, ways to handle data falsification, and scope of an FDA audit of data. Now let’s consider ethics as it applies to the workplace.

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Accept nothing less than the best from yourself and others. Does your laboratory have “ethical muscle”? It can be very simple. Stine actively represents L-A-B in accreditation activities with APLAC and ILAC which includes acting as the L-A-B delegate for MRA council decisions and participating in various committees assisting in development of international accreditation requirements. Third, they need to be encouraged to bring forward possible issues with their data and have enough integrity where their work is concerned to not alter their data in any way that is unacceptable. They are there for you to read, or not.

… Do you ask the question when you’re unsure or do you let it go, thinking that no one will care or notice? Let’s first consider how to train the employees. If you are a member of the team, challenge yourself to flex your own ethical muscles by fully participating in your laboratory’s ethics and data integrity program. First, employees in the laboratory need to be trained in how to correctly produce and review their data. The three most common data integrity issues cited by FDA for inspections from 2013 to 2015 were the lack of controls to prevent alterations of data by staff, failure to maintain records of accurate data, and delayed reporting of data. Good quality data is critical. Ethics and data integrity should be an integral part of your laboratory’s quality program. Data integrity violations can result in financial loss for pharmaceutical companies due to facility shutdown, product recalls, import bans, and delayed or denied drug approvals. One of the first questions I ask during the interview process when bringing on a new employee to be part of our laboratory team is the following: “How would you describe your work ethic?”. Second, they need to be trained in how to recognize data that is of questionable quality. Is this enough to ensure that all employees fully understand and retain the importance of this topic and will comply? So please consider turning off your ad blocker for our site.

While a recent increase in data integrity violations has prompted the FDA’s increased focus in this area, the majority of non-compliance citations in routine inspections result from poor systems rather than intentional fraudulent activity. It doesn’t have to be a complex process if you don’t want it to be. Based on this policy, procedures should be put in place that define exactly how the policy will be implemented and ensured. Having an appropriate work ethic leads to making sound ethical decisions in the laboratory. A formal policy regarding ethics and data integrity is also a good idea. However, someone has to pay for this content. Maybe there is a deadline that must be met for a research project or your boss is counting on you to finish the project in order to obtain funding for their next research endeavor. Jason Stine It’s that simple. And that’s where advertising comes in. All ads in Quality Digest apply directly to products and services that most of our readers need. Maybe you run across a situation with your own work that causes you to question whether it’s acceptable to do it this way or that way. Quality Digest does not charge readers for its content. Given that the FDA is clearly concerned about data integrity and intends to enforce cGMP rules related to this topic, how can you be sure that your operations are aligned with the FDA’s current thinking on data integrity? In other words, the FDA is applying a “guilty until proven innocent” approach to data integrity. How can your laboratory effectively provide “confidence in its competence, impartiality, judgment or operational integrity?” This can be ensured through the use of detailed policies, procedures, and a program that specifically addresses these topics. I would argue it also means being honest and forthright in the workplace. Discuss in Chemical Engineering from the University of Virginia and an M.B.A. from the Drexel University LeBow College of Business. A recent analysis by PricewaterhouseCoopers’ Health Research Institute (HRI) shows that a growing number of pharmaceutical companies have been warned by the FDA for data integrity violations since 2010 – from 2010 to 2012, the FDA warned five companies for such violations; between 2013 and 2015, the number was 24. Laboratories often state within their quality manuals that they ensure the integrity of their operations but provide limited details for how this is ensured. So please consider turning off your ad blocker for our site. What matters is that you have a sense of right and wrong as it applies to your job. Do you feel your employees are flexing this muscle? Dale Curtis Jr. is the President of Astrix Technology Group. Further, don’t release data until you are confident of its quality.

It may also mean starting over from square one. In addition, conduct a yearly refresher on this subject for all members of your team. Take these pitfalls into consideration as you develop your color measurement and management procedures, A brief survey of leading coordinate metrology solutions, Unique approach facilitates more proactive CAPA, mitigates cost of quality and recalls, Measuring before, during, and after a part build, Contactless gauging system for measuring steel wire for tires, copper wire for electrical cables, CO2 welding wire, and more, Resolve CMM productivity issues with MetraSCAN-R BLACK|Elite, CUBE-R 3D, and digital twin environment software, Videos address common topics related to surface specification, measurement, and interpretation, in five minutes or less, Scan 99% of parts without touching the scanner exposure, New AVX550 system combines best features of vision and touch-probe inspection, Scan was used to create 80% to-scale 3D-printed replica, Quickly captured complex geometries resulting in optimally designed roof racks and greatly accelerated completion time, Designed for scientists, engineers, technicians working in medical devices, automotive, aerospace, and other fields, New line of micrometers are easy to use, have enhanced features and performance, competitively priced, Log in or create FREE account to continue. ISO/IEC 17025, subclause 4.1.5 d, requires that your management system “have policies and procedures to avoid involvement in any activities that would diminish confidence in its competence, impartiality, judgment, or operational integrity.”. 4.4 Any data integrity identified shall be handled as per quality management system and risk assessment shall be performed wherever applicable. The laboratory should have a policy in place addressing the lab’s exact position on ethics, integrity, and code of conduct. From the perspective of regulatory agencies, data integrity violations arise from poor systematic control of data management systems. 5.3 Any identified data integrity issue shall be handled as per the quality management system and proper corrective and preventive action shall be taken according to risk assessment.

Enter your Quality Digest password. Training is the key to producing quality data. The main purpose of the guidance seems to provide clear and concise solutions to common issues in an easy to follow Q&A format. A few examples include improper manual integration, time travel, dry labbing, and unwarranted manipulation of computer software. By logging in you agree to receive communication from Quality Digest. Thanks,

Comment Rss “Quality Digest" is a trademark owned by Quality Circle Institute, Inc. You like FREE content. Do you feel your employees are flexing this muscle? There may also be some kind of a confidentially or ethics agreement in place that personnel signed when hired. As a fellow scientist, I am passionate about ethics and data integrity. For over 18 years, Mr. Curtis has built an impressive track record of leadership and success in high technology/scientific enterprise software sales, business development and service delivery. If you are a manager, encourage your team to flex their ethical muscles. Then you need to know how to sustain. In addition…document, document, document. Many companies simply fail to employ robust systems with built-in features that inhibit data integrity failures.

I don’t claim to have all the answers, but I seek those answers when needed. However, someone has to pay for this content. According to Mirriam-Webster, it is “the principles of conduct governing an individual or group.” But its simpler meaning is to do what’s right and not do what’s wrong, with the assumption that all individuals know the right thing to do. A formal policy regarding ethics and data integrity is also a good idea. For the quality assurance managers out there, an excellent way of achieving this is to perform periodic monitoring of data integrity. Consider how ethics relates to data integrity for laboratories. Enter your Quality Digest username OR email address. Astrix 360 Degree Laboratory Informatics Services, Scientific and Technical Outsourced Services, Good Data and Records Management Practices, good manufacturing practice (GMP) guidance to ensure the integrity of data, According to a recent article published in BioProcess International, Laboratory Informatics Webcast Series – The Digital Laboratory: What the Future Holds, Tips for SampleManager LIMS Instrument Integration, Tips for SampleManager Implementation and Upgrades, National Institutes of Health (NIH) Research Updates – October 2020, The World Health Organization (WHO) published its final version of “, The European Medicines Agency (EMA) issued, The Food and Drug Administration (FDA) issued a “. Good quality data is also critical for trust…trust from the laboratories’ customers, regulatory agencies, and your fellow coworkers and management team. Laboratories often state within their quality manuals that they ensure the integrity of their operations but provide limited details for how this is ensured. Author Archive At the other end of the spectrum, managers have the moral duty to uphold their end of the bargain.

Inform them and empower them to make the right choices. This leads to data produced in laboratories being of good quality. We believe that industry news is important for you to do your job, and Quality Digest supports businesses of all types. We like getting a paycheck. Especially critical is that they practice the true corrective action if their data does not pass the assigned quality-control criteria. Print Out of the nearly 10 years technical experience that Jason Stine has in various ISO/IEC 17025 mechanical testing laboratories, he has served more than five years as the testing program manager and the lead assessor for Laboratory Accreditation Bureau (L-A-B), performing  assessements of more than 75 laboratories.

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