ERA Sciences’ Post

Lots of companies apply a risk based approach to data integrity including training and focus efforts where they are needed most. It was great to be involved in the SGS data integrity training journey where no one just sits back and everyone challenges the status quo. We had great discussions on #ALCOA++ and what traceable data really means. We looked at #21CFRpart11 and #Annex11 requirements and worked examples of how these apply to CxO operations SGS. We also looked at Predicate rules and how most data integrity searches in WLs and 483s focus on these first rather than Part 11. Thanks to Darren Mc Connon, Donal Golden and all 80 attendees for brilliant engagement during training and commitment to data integrity excellence. 😞 And to prove a point about poor data integrity practices Posted on 03/Dec/2024 we again see data integrity violations being cited by FDA in this warning letter to LCC Ltd where non compliance with 211.166(a), 211.22(a), 21 CFR 211.160(b)) and 211.194(a) all rear their heads https://lnkd.in/eCvRZ9-Y

Turn the FDA inspection into an opportunity for growth and development. 🌱 While you usually receive an announcement at least 5 days before an inspection, the FDA could also show up unannounced. This unpredictability underscores the importance of having a QMS that's inspection-ready. Here are three ways you can consistently maintain readiness, making your organization audit-ready as an ongoing, perpetual process: 1️⃣ Cultivate a culture of quality: - Instill a company-wide appreciation for the significance of quality. - Incorporate ALCOA++ standards from the outset to uphold data integrity and precision. 2️⃣ Conduct regular internal audits for compliance: - Establish a proficient internal audit team. - Utilize internal audits to proactively identify and resolve issues. - Prioritize self-correction over waiting for FDA findings to maintain compliance and uphold quality standards. 3️⃣ Understand your role: - Prepare to respond to inquiries about your position, duties, and training. - Ensure clarity among all team members regarding their roles and responsibilities within the organization. ⬇ To discover more best practices and tips, take a look at our detailed guide! #QMS #QualityManagement #Inspection #Compliance

Testing and calibration laboratories play a critical role in ensuring the accuracy and reliability of measurements and tests across various industries. #compliance #accreditation #accredited #accreditedinvestors #iso #regionalsalesmanager #accreditedtraining #accreditations #accreditedinvestor #vision #conformity #assessment #bodies #ensure #credibility #report #certification

I'm happy to share that I have completed a course and received a certificate in ISO/IEC: 17025 from sciences co. During the course, I learned about the following important topics: - Types of laboratories - Health and safety protocols in laboratories - Classification of laboratory equipment - Basic components of the standard - Important terms and their definitions - Various devices used in laboratories and their types #ISO17025 #quality #certificate

Ensure Ofqual compliance with monthly reviews, one criterion at a time, guided by expert support. #OfqualCompliance #AwardingOrganisations #UKEducation #QualityAssurance #RegulatoryCompliance #EducationStandards #ComplianceReview #ProfessionalDevelopment #UKBusinessSupport #EducationLeadership #ExternalReviewer #UKQualifications #StandardsInEducation #ContinuousImprovement #RegulatedQualifications

Lean Six Sigma helps in compliance and regulation by optimizing processes, minimizing errors, and ensuring consistency, which are essential for meeting regulatory requirements. #LeanSixSigma #complianceandregulation #Certification #CareerGrowth #ProcessImprovement #AccreditedProgram #QualityManagement #IMCInstitute #leansixsigmacertification

#Iso 17025 tutorial series Case Study: A Critical Finding During an ISO 17025 Audit in a Dairy Testing Lab During a routine ISO/IEC 17025 surveillance audit for a dairy testing laboratory accredited by EGAC, the auditor uncovered multiple systemic issues that could lead to non-conformities: 1. The calibration standards (CRMs) for the milk analyzer used to test fat content were found to have expired three months earlier. Additionally, no documentation existed to demonstrate the traceability of these standards to a national or international metrological institute. 2. Upon reviewing the laboratory's measurement uncertainty (MU) calculations, it was revealed that several critical factors, such as environmental conditions (temperature variations common in the Middle East) and sample homogeneity, had not been considered. This resulted in underestimation of the MU for fat content testing by as much as 20%. 3. The laboratory's internal audit program did not detect the calibration or MU deficiencies, as it lacked detailed checks for traceability and technical soundness of the calibration process. 4. Outdated calibration data had been used for testing and issuing results to clients. Some of these results were near regulatory limits for fat content, potentially jeopardizing compliance with local standards. Question: If you were the auditor in this case, what Non-Conformities (NC) would you raise, and under which clauses of ISO/IEC 17025? Moreover, what corrective actions would you expect the lab to implement to resolve and prevent such issues in the future? Case study solving in comments! 👇 #Iso17025 #accredited_lab #knowledge_through_implementation

Knowledge gaining is best process in life and never ending in life. Thank you very much sir, Dr. #ChannaGhosh and team #HSSERisk, for organizing the Global Training course on ISO 14064. Very well organized and delivered training on: ISO 14064-1: 2018 for quantifying and reporting of GHGs emissions and removal at organizational levels. ISO 14064-2: 2019 GHG specifications with guidance at project level for quantifying, monitoring, and reporting of GHG reductions or removal enhancements. ISO 14064-3: 2019 for verifying and validating GHGs statements. ISO 14066: 2011 GHGs competence requirements. ISO 14067: 2018 for carbon footprint of products- requirements and guidelines for quantification. All aspects covered in a simplified way, keep educating and arranging such programs, that's the need of the hour!

A common problem in quality management: we get lumped with all the compliance activity and can be cornered into a role where we end up nagging to get stuff done, because "NATA is coming". If you feel like this is happening to you / your quality manager, check the link to blog in the comments below ⬇️ #ISO17025 #ISO15189 #laboratory #accreditation #NATA #GLP #NATAFAQs

“TO ACQUIRE KNOWLEDGE, ONE MUST STUDY; BUT TO ACQUIRE WISDOM, ONE MUST OBSERVE” An interactive session was conducted for EHS Champions at the Abbott Landhi plant on the topic of ISO 45001 and 14001 standards. Focus was on EHS capability enhancement through simulation on day today practical scenarios. #abbottproud #ehs #iso #teamwork #learninganddevelopment