Author Archives: Ken Lownie

Beyond Compliance: How a Training Module Optimizes Quality

Training Management in QMS

Compliance with industry regulations is often the focal point in discussions about quality management systems (QMS). That’s not surprising since adherence to standards and regulations is an existential issue for any pharma company. However, another element of QMS systems that deserves more attention is how a complete QMS can drive teams to very high levels

Scigeniq Celebrates Rapid Growth, New Customers and Record Results

Scigeniq announces Q2, Q3 results

Dubai, UAE – October 3, 2023: Scigeniq, a provider of advisory services and software applications, announces continued rapid growth in the second and third quarters of 2023, adding to its product portfolio and dramatically expanding its customer base in the MENA region as well as Brazil.   In recent comments, Jawad Kamal, the CEO of

Preparing for Electronic Batch Records: A “To Do” List for Quality Managers

Preparing for Electronic Batch Records: A “To Do” List for Quality Managers

Quality and manufacturing managers know that a method for documenting and reviewing accurate batch records is the single most important element in a pharmaceutical manufacturing and quality process. That’s because, without accurate batch records, even a well-designed quality system will be vulnerable to audit findings and warning letters. After all, nobody wants to receive a

EBR and QMS Integration: Unlocking the Power of Detective Work in Pharmaceutical Manufacturing

EBR and QMS as a detective

Electronic Batch Records (EBRs) occupy a unique position in the complex world of pharmaceutical manufacturing, bridging the realms of Manufacturing Execution Systems (MES) and quality management and compliance systems. Traditionally viewed as records of production activities, EBRs have evolved into much more than mere documentation. They embody instructions, standard operating procedures (SOPs), recipes, and records,

Did You Say You’re Using an ERP System for Quality Management?

ERP is not a QMS

The first time I heard someone say they were considering using their ERP platform as their quality management system (QMS), I was pretty sure I had misheard them. However, by the third time I heard it, I realized my hearing was fine. I think it’s important to talk about this because leveraging an ERP platform

Regulatory Compliance Starts with Effective Document Management

Effective Document management in Pharma

Document management is an essential function for pharmaceutical companies. It allows them to efficiently store, organize, and retrieve important documents related to drug development, clinical trials, manufacturing, distribution, and other business critical information. Failure to effectively manage these documents can result in serious consequences such as fines, delays in product launch, and even legal action.