Events

Digital Solution for Pharmaceutical Quality systems

  In the present market of the pharmaceutical industry, there is no clear idea about the influence of digitalization in the industry. This is due to the lack of understanding of potential opportunities created by digitalization. Let us discuss some cases to understand how digital solutions for pharma quality systems can transform Quality in...

How to Select a Productive and GMP Compliant Automated System?

Due to increased regulatory compliance in the pharma manufacturing industry, Clinical laboratories are feeling the pressure to ensure GMP compliance while balancing the productivity demand on the other side. Handling large sample sets successfully and automating the workflows of complex multi-step processes will significantly increase productivity. It will also help us to introduce advanced...

Why should you automate your manual paper-based logbooks?

eLog or logbook software helps to record all the details or logs at the right time. It also helps in verification, reviewing and approval of these details in logbooks. Dispersion of logs between various departments such as quality, planning, production and maintenance increases the transparency of the production process of the organisation. Challenges with...

CSA (Computer Software Assurance) A move from Traditional CSV

FDA’s Draft Guidance on Computer Software Assurance for Manufacturing, Operations and Quality System Software has emphasized on ‘Critical Thinking’ to be a crucial part while implementation of automated systems. In brief it is a paradigm shift from document focused computer system validation practices to critical thinking assurance practices. The industry and the FDA are...

Why Do We Need to Automate Deviation Management in Pharma?

Automated deviation management will initiate and process all the corrective actions across All the Operations and dispositions. Challenges with manual paper-based deviation management Manual Deviation Management involves reports, Excel spreadsheets and Microsoft Word documents for reporting and tracking the adverse events which include deviations, defects, laboratory incidents and issues with supplied material. Daily meetings...

How to Implement a Learning Management System Software(LMS) for a Faster Growing Company?

It is challenging to manage employee training without a proper learning management system software in a rapidly growing organisation especially in companies where there are frequent updates in manufacturing practices and guidelines. Many organisations will have a limited training budget and a small training team which is not sufficient for their training needs.  Employee...

What are the Key Features of a GMP Compliant Automated QMS?

Many life science manufacturing companies want to implement GMP compliant automated qms to streamline their processes. As a result, their quality management systems have become more efficient and leaner. Organisations with automated quality management systems save a lot of time. Now, their employees can focus on more value-added activities where there is a bigger...

Low Code Platforms for Pharma QMS Software! A Right Choice?

Electronic Quality Management System (eQMS) software for pharma companies The pharmaceutical industries have to deliver products with the highest level of quality and safety to the market. In case of any issues, companies might face a recall, a loss of credibility and brand equity, as well as revenue. Keeping this in mind we have...

Document Tracking System For a Business to Get Succeed

In the beginning, many companies used to manage their documents manually with a mixture of papers, spreadsheets and file cabinet storage systems. As the company grows and with it’s the volume of information and File storage will also grow. The process of manual document management will be slow, time-consuming, prone to errors, missing documents...

Case Study on QMS Software for Pharmaceutical Industry

QMS Software for Pharmaceutical Industry, Pharma Quality Systems Read how this client found its solution in AmpleLogic Quality Solutions‘ automated platform, enabling it to manage its QMS Process like CAPA, Change Control, Market Complaints, Deviation, OOS/OOT and Audit Management Activities with standardized processes and have instant visibility in a real-time. AmpleLogic offers a complete...