AmpleLogic Annual Product Quality Review (APQR)

11 reviews

AmpleLogic Annual Product Quality Review (APQR) Software is a web and cloud based application that eliminates the need for a paper based documentation required for review of every batch product manufactured

AmpleLogic Application Platform as a Service (aPaaS)

11 reviews

LOW CODE Application Development Platform How does it sound to develop an instant application? With AmpleLogic, developing applications is as simple as drag and drop to create the workflow. When you create apps with us, you can develop it 10X faster with ROI in 3 months.

AmpleLogic QC Planning and Scheduling

10 reviews

Life Sciences companies include Pharmaceutical, Contract Development and Manufacturing Organization (CDMO), Biotechnology, Contract Research Organization (CRO) and Biosimilars continue to operate in a highly competitive environment. The Quality Control (QC) laboratory in a pharmaceutical company plays a critical role in the testing of Raw Materials, Stability, In-process and FG Samples. QC Analysts from different sections analyze incoming samples of different kinds. These include Finished Goods (FG), in-process products, stability samples, and environmental samples. Analysts may also be required to analyze raw materials. In organizations with diversified drug products, the number of samples to be tested per week will range from 150 – 400 Samples and each sample must go through a minimum of 6 tests. In such a scenario it is a challenge to prioritize the samples and assign equipment like HPLC/GC to the QC Analyst manually. HOD’s of QC Labs are under steady pressure to improve the lab operations in order to meet the Sample TAT (Turn Around Time). The equipment used in the Pharmaceutical and Biotech product testing are highly sophisticated, extremely sensitive, and very expensive. Maximizing both staff (Laboratory technicians and managers) time and machine time is essential in the QC lab to address the problems of varying demands and to maximize resource efficiency. Consequently, Planners/Managers are finding a way to move towards lean QC lab by improving their processes, improving effective utilization of resources, reducing lead times, and at the same time, increasing reliability by accelerating authorization processes for compliance. This affects both production and batch release. A good Quality Control Planning describes how an organization will achieve its quality goals by specifying the quality assurance and control activities which are performed as part of daily lab operations

AmpleLogic Stability Management

10 reviews

AmpleLogic’s Stability Management Software is a comprehensive cGMP software designed to satisfy the demands of biotech, life sciences, pharmaceutical stability testing programs, and stability management. This Stability Management Software helps to simplify and test their organization’s operations and also specify the testing parameters for stability investigations

AmpleLogic Electronic Logbook (eLogbook)

9 reviews

AmpleLogic Electronic Logbook is a web-based software or platform that records general production requirements and keeps track of Area and Equipment operational usage, Packing, Cleaning, Break Down, Clearance, and Preventive Maintenance, Fogging and Defogging Log, Granulation, Calibration, Equipment Usage, Stability Schedule, Standards Usage, Service Log, Dispensing, Production, Chemical Usage Log, and many other equipment details log. This eLogbook Software is designed to assist users in converting manual paper forms to electronic equivalents. Additionally, the logbook software guarantees that details or log are entered accurately and on time, and that they may be validated, reviewed, and authorized via approval workflows. AmpleLogic Equipment Usage Logbook Software is compliant with FDA regulations governing electronic records and signatures, including 21 CFR Part 11. This solution also complies with other regulatory standards such as EU Annex 11, MHRA, GAMP, Good Manufacturing Practice (GMP), Standard Operating Procedures (SOP’s), and ISO. The software was created having in mind the requirements of major regulatory authorities, and to better serve our clients The AmpleLogic eLogbook Software/Electronic Logbook guarantees that information is disseminated throughout the organization’s essential operational departments including the quality, production, planning, and maintenance departments; and they serve to bring clarity and transparency to the entire organization’s production and QC lab activities.

AmpleLogic Electronic Batch Manufacturing Record (EBMR)

7 reviews

AmpleLogic Electronic Batch Manufacturing Record (eBMR) Software is designed for pharmaceutical companies to automate manual paper-based batch manufacturing records to ensure compliance.