How Digitisation Can Optimise Your Stability Sample Management Process
How Digitisation Can Optimise Your Stability Sample Management Process Stability programmes are rarely short of compliance attention. Regulators expect them to be robust, and most quality teams already know where the risks sit. But there is another question that gets asked less often: how much time, space and effort does the process consume simply to […]
Leveraging Digital to Reduce Risk and Improve Compliance in Stability Sample Management
Leveraging Digital to Reduce Risk and Improve Compliance in Stability Sample Management Stability Sample Management is a critical process for all Pharma and BioPharma sites. It provides the ongoing assurance regulators demand that a product will remain safe and effective throughout its labelled life. And yet, at many sites, the process that underpins all of […]
How Targeted Power Apps Coaching Accelerated Delivery for a MedTech Client
How Targeted Power Apps Coaching Accelerated Delivery for a MedTech Client Many organisations adopt Microsoft Power Apps because it enables business users to build solutions without traditional software development expertise. However, while Power Apps is accessible, developing robust and maintainable business applications still requires good design decisions, sound architecture and practical development experience. For one […]
AI Governance in GxP Environments: 5 Pillars for Validation and Compliance
AI Governance in GxP Environments: 5 Pillars for Validation and Compliance Artificial intelligence is increasingly being considered for use across regulated pharmaceutical and life sciences environments. However, AI presents challenges that traditional computer system validation approaches were not originally designed to address. Traditional validation typically assumes that software behaves predictably and consistently. Artificial intelligence, particularly […]
Replacing Paper Logs: eLogBook Ticks all the Boxes
Replacing Paper Logs: eLogBook Ticks all the Boxes Paper log books are still widely used across manufacturing and laboratory environments for recording routine readings, checks and inspections. Dataworks eLogBook provides a practical digital alternative to paper-based records. The user-friendly application runs on tablets, mobile phones and desktop computers, allowing users to record readings and checks […]
Addressing Digital Gaps in Manufacturing Sites
Addressing Digital Gaps in Manufacturing Sites Most pharmaceutical and medical device manufacturers aren’t short on data. They’re short on connections between the data they already have. A shop floor system tracks output. A quality system tracks deviations. An enterprise platform tracks orders and inventory. Each one does its job well on its own, and that’s […]
Dataworks Partners with NIBRT to Deliver Power BI Training for BioPharma
Dataworks Partners with NIBRT to Deliver Power BI Training for BioPharma Dataworks is delighted to announce a new training partnership with NIBRT, one of the world’s leading organisations for biopharmaceutical manufacturing training and research. Through this partnership, Dataworks will deliver practical Microsoft Power Platform courses for professionals working in pharmaceutical and biopharmaceutical environments. Practical Digital […]
Supporting Your Manufacturing Methodology with Digital Solutions
Supporting Your Manufacturing Methodology with Digital Solutions Walk onto almost any Medical Device or Pharma manufacturing floor and you’ll find a system already at work – Tiered Meeting, Visual Management Boards, KPI trackers, Leader Standard Work and other tools. Today, digital solutions for manufacturing can strengthen these established ways of working without replacing the methodology behind them. Whether you call it a Manufacturing System, an Operational […]
Continued Process Verification in Pharma: A Practical Guide to Ongoing Process Validation
Continued Process Verification in Pharma: A Practical Guide to Ongoing Process Validation Moving Beyond Validation Completion: How CPV Ensures Pharmaceutical Processes Remain in a State of Control In pharmaceutical manufacturing, validation is no longer considered a one-time activity completed after successful process qualification batches. Regulatory expectations have evolved toward a lifecycle approach, where manufacturers must […]
GMP Inspection Readiness: Building a Validation Programme That Stands Up to Audit
GMP Inspection Readiness: Building a Validation Programme That Stands Up to Audit In today’s highly regulated GMP environment, inspection readiness has become a critical measure of an organisation’s quality maturity. Building a validation programme that can withstand audit scrutiny is no longer just about completing documentation; it is about demonstrating control, consistency, and a […]