Tag: GMP Compliance

  • Utilizing Blue Mountain RAM to Enhance Change Control Processes

    It is a requirement for organizations to track changes in a GMP environment. Effective and efficient change control processes are key to achieving quality and compliance. At this month’s Blue Mountain Customer Lab, we took a few polls of our audience to determine how customers are currently tracking changes. The results were as follows: 39% […]

  • Blue Mountain RAM Workflow Capabilities

    At February’s Blue Mountain Customer Lab, we discussed how workflow management is a major driver for compliance and productivity. Therefore, a powerful workflow automation engine is a key component of an effective and compliant paperless system. Blue Mountain RAM’s Rule Builder is an interval piece of the system that manages workflow automation. The Rule Builder […]

  • The Impact of Quality Standards on Compounding Pharmacies

    Pharmaceutical compounding as we know today has grown exponentially since its origin – creating greater complexities than ever before. Drug compounding was once the job of local community pharmacists – preparing personalized medications based on patient-specific needs. More recently, the industry experienced a growth in mass production of compounded drugs due an increase in cost. […]

  • The FDA’s New Draft Guidance

    More recently, the FDA has begun seeing data integrity as a major concern to the violations discovered during audits. As a result, the FDA published its new draft guidance, Data Integrity and Compliance with cGMP, in April 2016 with the purpose to provide organizations with recommendations to ensure reliable and precise data documentation; which will […]

  • Could The United Kingdom Be The Next Life Sciences Hub?

    Implications of the Historic Brexit Verdict Since the final votes of the Brexit were counted, a majority of the UK’s decision to leave the EU has appeared pessimistic for the Biotech and Pharmaceuticals industries. As a result, there has been very little talk about any positive outcomes for the Life Sciences. Yet, can we truly […]

  • Departmental Roles of Data Integrity

    Adherence to cGMPs is vital to all Life Sciences manufacturers and data integrity is one component that impacts cGMP. A corporation’s data integrity is influenced by everyone at an organization. As a result, it is essential that employees at all levels understand their roles and responsibilities with data integrity. Let’s take a look at a […]

  • What Is Data Integrity?

    Data integrity is vital to success in cGMP manufacturing. Companies can produce safer and higher quality products when they document reliable, accurate data. However, in order to ensure data integrity in your organization, you must first have a good understanding of what data integrity is. The FDA defines data integrity as “complete, consistent and accurate […]

  • The Difference Between Industry Standards: GAMP, ASTM, and ICH

    We often get questions from our customers about adherence to different industry standards.  “Which ONE do you follow?” The answer is not as simple as it appears. In fact, the question itself is much more complex. Theories and standards of GAMP, ASTM E2500, ICH Q8, ICH Q9, ICH Q10, and 21CFR part 11 work together […]

  • Lean Manufacturing Series: Lean in the Life Sciences Industry

    Lean manufacturing is becoming prominent in the Life Sciences industry. The model has seen much success in a variety of other industries. This blog series will focus on revealing how Enterprise Asset Management (EAM) can drive lean. We will shed light on lean in the Life Sciences industry; digging deeper into the understanding of how […]

  • Compliance Series 6: Leveraging EAM Functionality to Manage Compliance Risks

    Now that I laid the framework for purpose-built EAM software and some core functionality requirements for regulated companies, I want to go into more detail about using EAM/CMMS features to manage compliance risks.  There are two important factors to note surrounding EAM/CMMSs in GMP environments: Maintenance and calibration work should be streamlined and simplified for […]