Novatek Presentation: Trending EM Data and Considerations for Automation Novatek Case Study: How Pattern Recognition and Trending Assist in Root Cause Analysis Key Learnings: This case study is a real world exercise on how a to use a process based automated system to determine the root cause of multiple contamination events in a Grade D room. The…
Novatek was proud to feature their latest solution on the Automation of Cleaning Validation at the 11th Annual PDA Global Conference on Pharmaceutical Microbiology Poster Presentation. Our contribution to this year’s poster series was led by Susan Cleary, Director of Product Development at Novatek International. Our aim was to demonstrate the further use of software technology…
Environmental Monitoring (EM) programs for pharmaceutical manufacturing are evolving to a risk-based approach. The use of sampling data for the identification and mitigation of risk becomes a critical element in this process. No longer is it enough to utilize data for reactive excursion reporting. The case study provided in this white paper highlights the need…
TRANSFORM IDEAS INTO WINNING PROJECTS… Successful innovation programs more and more key to driving corporate growth and maintaining competitive advantage. Innovation programs must be sustainable and agile to keep pace with today’s rapidly changing environments. Companies struggle with how to establish and sustain the innovation process. Persons within the organization are an excellent resource for…
All healthcare and life science organizations that develop and manufacture products rely greatly on accurate informative text and printed labels to communicate to their end user and build their product brands successfully. Novatek’s software provides effective proof reading results to support the industry’s highest standards; eliminating printing errors in all product information documents thus holding…
In clinical studies, assessing and managing risks, as well as establishing areas of uncertainty that contribute to risk, are critical to a company’s decision making processes. Many business units within pharmaceutical, biotechnology and clinical research organizations must comply with federal regulations concerning their processes and computerized systems. One of the most challenging processes throughout clinical…
The inventory and tracking of columns and identifying what solvents are in an HPLC column are time consuming and challenging tasks for any laboratory within healthcare and life sciences organizations. Lab analysts within the research and or quality control departments must be aware of the packaging material and dimensions of their columns so they can…
Manual inventory systems can produce a large amount of time consuming paperwork requiring increased resources that that can increase operating costs. Investing in a inventory management system is essential to reduce the risk of incorrect or unreliable inventory records do the manual management and recording of data. Novatek’s Consumable Inventory Management software is a powerful…
Novatek’s Validation Management software creates a roadmap for validation practices that goes beyond customer processes, and promotes unified data views across any organization. The system is designed for variety of processes some of which that include: Validations Workload Forecasting Sample Inventory Sample Management Control & Distribution Testing of Validation Samples This type of information is…
Maintaining consistent product quality and quality processes can be challenging in today’s manufacturing environments. Regulated industries such as the Pharmaceutical, Biotech and Life Sciences are required to maintain Good Manufacturing Practices (GMP) to meet regulatory requirements. Not only do you need to meet GMP requirements you must also be able to prove this to the…
