White Papers
  • The Pharmaceuticals, biotechnology manufacturing companies’ annual product quality review uses excel spreadsheets and other legacy systems for data analysis, but it is very time consuming, cumbersome and labor intensive and requires a lot of efforts and manpower to produce annual quality review reports. Annual Product Quality Review (APQR) or Product Quality Review (PQR) is a Read More …

  • All the pharma manufacturing companies are required to keep logbooks in place for documentation of usage logs of equipments, calibration, preventive maintenance, environmental conditions, cleaning, repairs, quality control logs, stability logs and other major equipment logs and needs to comply with Good Manufacturing Practices (GMP) regulations. They maintain different sets of logbooks depending on the Read More …

  • Finding the right Learning Management Solution to either replace your traditional methods of compliance training or switch to Electronic LMS System that is crucial to meet the learning requirements of your organization. There are many different LMSs system on the market. In many cases, they provide number of similar functionalities and features that you should keep Read More …

  • Are you thinking of investing in a new electronic quality management software (eQMS) for your organization? You have heard so much about how the software can help companies swiftly deliver the best quality products and are interested in it.  Companies should look for an eQMS solution that will provide a rapid return on investment. Most importantly, Read More …

  • Large Life Sciences, Biotechnology and Pharmaceutical drug manufacturers accumulate large volume of quality and regulatory documents to complete every week. As a result the retrieval and storage of these documents can become increasingly problematic and costly. Between the documents required for process workflow, compliance, and auditing purposes, it can be difficult to track the necessary Read More …

  • Training Management Solution for Pharmaceutical Industry Traditionally, a paper-based and legacy systems has been used in life sciences, pharmaceutical, biotechnology and other drug manufacturing organizations for documenting all training completions and it is critical that organizations are able to keep the accurate records of individuals and their training plans. But as these companies grow in Read More …

  • Integrated management systems with the Integration of different quality management systems can increase efficiency, accuracy and effectiveness. It also helps to reduce costs due to unnecessary delays. It is essential for any organisation to increase its performance for continuous improvement and maintains their employee and customer satisfaction. Integrated systems let your management systems work together Read More …

  • In recent years due to the advancement in the Lifesciences manufacturing technology, a lot of data is available and it becomes necessary to collect, store and organise this data. Pharmaceutical companies, therefore, considering Artificial Intelligence and big data as a solution for their data management challenges. The key insights which can be derived from the data can Read More …

  • The Life sciences manufacturing industry such as pharmaceutical, biotech and API manufacturers is under constant pressure to manage the increasing complexity of their operations with strict regulatory requirements and frequent changes. Now many manufacturers realised the need for enhancing the agility and flexibility of their Quality Management System(QMS) to meet market needs. But, this has Read More …

  • As we know that Life sciences companies such as pharmaceutical, biotech and API manufacturers need to meet minimum standards which are called GMPs in its product development and execution phase to get their product or process accepted. These standards include hygienic practices, work environment, record keeping, specification, testing procedures of finished products. Data integrity has Read More …

  •   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 the Read More …

  • 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 innovative technologies on Read More …

  • 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 manual Read More …

  • 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 with Read More …

  • 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 training Read More …

  • 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 impact. Read More …

  • Low-code platforms for pharma QMS software development is preferable because it makes easy to change the existing pharmaceutical Quality management software to suit the new requirements of the industry. 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 Read More …

  • 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 and Read More …

  • Pharmaceutical, Health Care, Life Science, and Biotech are few of the industries are operating under various quality and regulatory standard bodies like US FDA, MHRA, EMEA, WHO, TGA and CDSCO. As these drug manufacturing industries are delivering drug products to enhance the level of health of mankind, hence need to ensure the safety, efficacy, and Read More …

  • Benefits of Training Management System Here’s what a Training Management System can, and should, do for you: Learning or Training Management System makes it very easy for trainers to update existing training content or add new content in a short timeComply and Meet essential regulatory requirements and other best practices more easily Enhance managers and Read More …

  • The Role of Quality Management System (QMS) in pharmaceutical drug manufacturing industries is very crucial. When you are working in any life sciences industries, it is a fact that regulations and inspections are becoming very strict for both small to large-sized companies. A thorough Quality Management System (QMS) supported by any IT Systems or paper-based Read More …

  • Before explaining the benefits of Low Code Application Development or No Code App Development Platform, let’s first understand the problems with the traditional method of application development. The traditional process includes an enormous amount of coding, involves interrupted maintenance and has bugs that need to be found and fixed. A new update in any application (either for web Read More …

  • AmpleLogic Corrective and Preventive Action(CAPA) Software To manage the quality of any system or organization CAPA is required. Corrective and Preventive Action (CAPA) Software helps in addressing and improving the real-time problems of the Pharmaceutical, Biotechnology and Life Science industries, ensuring that each identified risk and the problem addressed completely in compliance with 21 CFR Read More …

  • AmpleLogic Pharma GMP Compliance software system has been pre-configured to specifically address the requirements with the standards of FDA, 21 CFR part 11, EU Annex 11 and other regulatory bodies. Pharmaceutical Business Process – Ready to Use Modules