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Out of Trend Software

The chemical, instrumental, microbiological, and physical analysis of the raw materials and finished goods samples generates a large amount of informative data for the Life Sciences Industry from the Quality Control Labs. Drug production companies use QC Sample Out of Trend (OOT) to make sure that the products meet the laid down specifications. This important information will be used to predict and revise alerts and action limits for quality specifications. In a case where sample results differ or deviate from the sample’s historical results, a case of Out of Trend must be investigated.

Annual Product Quality Review (APQR) Software

Every commercial product manufactured in the Pharmaceutical, Biotech, and Bio-sciences Industries undergo a Product Quality Review (PQR). This requirement is published as the final current good manufacturing practices (CGMP) regulations for drug products (21 CFR 211.180(e), 21 CFR 211.180(e)).

The PQR has largely been termed ‘Product Annual Review’ or the ‘Annual Product Review’ (APQR) by FDA and within the pharmaceutical industry. The products follow the established protocols of the US FDA with GMP standards, and they are distributed within the United States markets. Read more to know about AmpleLogic’s APQR product.

Compliance Management Software

The Compliance Management System is a one-of-a-kind web-based solution from AmpleLogic. It contributes to operational clarity by organizing a set of internal controls that are carried out accurately in accordance with the constantly changing requirements. These criteria are derived mostly from regulatory standards, policies, legislation, and regulations that have been made public to facilitate manufacturing.

Microbial Environmental Monitoring Software

Currently Pharma companies are manually testing lifecycle management for various types of monitoring i.e. Air, Surface, Water, Personnel etc. and its difficult to manually record sampling data, incubation, result recording, reporting. Its difficult to manually record observations for monitoring of settle plate, microbial air sampling, microbial surface monitoring, Non viable particle monitoring etc.

AmpleLogic Environmental Monitoring (EM) software mitigates the current industry challenges to ensure product safety during the drug production process. Our software is compliant with the regulatory standards of organizations such as the US Food and Drug Administration (US FDA) and MHRA.

Lab Incident Reporting Software

The Lab Incident Reporting Solution is a web-based application designed for pharmaceutical, biotech, healthcare, and life science organizations to enable digital incident management while also making sure of effective documentation, assessment, reporting, and escalation.

Out of Specification Software

All test results that exceed the stipulated limits defined by the manufacturer in the drug applications and drug master files (DMFs) are included in the OOS results of the samples.

Electronic Batch Record (eBMR) Software

In the Life Sciences Industry, a batch record confirms that an organization manages and documents all important procedures involved in producing a batch of a product properly. Current batch manufacturing records in GMP environments use manual recording methods.

By implementing AmpleLogic eBMR, an electronic batch record system (eBMR), organizations can enhance the integrity and accuracy of their data. It has the potential to streamline procedures and boost operational efficiency, which has a beneficial effect on the bottom line.

Calibration Management Software

Calibration is important for all equipment used in the processing and assessment of resources and products. Time, date, calibration date, and next calibration are all included in a paper calibration record that is cumbersome to keep track of. The paper-based recording of calibration schedules may result in audit observations and documentation on paper is tedious and vulnerable to human mistakes, even if it is compliant with rules.

To ensure that instruments are calibrated correctly, the AmpleLogic calibration schedules tracking system ensures that preventative maintenance of the equipment is conducted accurately and on time. With our Calibration Management and Tracking Software, organizations can increase efficiency, decrease burden, and develop an efficient calibration program that conforms with 21 CFR Part 11 as well as EU Annex 11 regulations.

LMS – Learning Management System

AmpleLogic’s Learning Management System (LMS) is designed to organize and monitor a vast number of GMP and non-GMP training for life sciences, pharmaceutical manufacturing, biotechnology, and contract research organizations (CROs), including SOP, technical, HR, external, and research training. AmpleLogic Training Software aids in determining training requirements depending on a user’s Role. It’s also possible to create a department-specific training calendar, carry out and assess various forms of employee training programs, guarantee compliance through appropriate tracking, and keep training records annually with the creation of reports for management review.

Electronic Logbook (eLogbook) Software

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 Logs, Granulation, Calibration, Equipment Usage, Stability Schedule, Standards Usage, Service Logs, Dispensing, Production, Chemical Usage Logs, 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 logs are entered accurately and on time, and that they may be validated, reviewed and authorized via approval workflows.

Alarm Management System

The roles of alarms in the life sciences industry cannot be underestimated. Given how influential they are on product quality, they are monitored and given close attention. As a result, many companies have established clear-cut procedures for manage their alarm systems.

The reality of Pharma 4.0 in this fast-paced and scientifically advanced age has rendered manual monitoring of alarms largely inefficient. The consequences of the lapses and shortcomings of a manually monitored alarm could prompt 483 observations from the US FDA. Pharmaceutical, biotech, biosimilar, and API manufacturing industries are some of the life sciences organizations that need to put in place adequate facilities and systems that would aid their alarm management.

Electronic Document Management (DMS) Software

In order to keep up with the pace and compete in the dynamic market, adopting automation is a vital first step for any pharmaceutical, biotechnology, life sciences, and medical device company involved.

Managing documents from several sources becomes challenging and time-consuming. AmpleLogic Electronic Document Management System (EDMS) ensures the best experience to handle all documents and helps organizations manage them on the go from anywhere. Our software is exclusively designed for Pharmaceutical and Biotech companies, developed and implemented exclusively to meet the cGMP needs of Pharma domain with 21CFR Part 11 compliance, EU Annex 11 compliance  can easily  eliminate all the challenges faced by different companies

Quality Control Solutions in Pharmaceutical Industry

AmpleLogic Pharma Quality Control Laboratory Automation Solution i.e. Stability Studies and schedules Management, Standards Management and Column Management modules implemented at USFDA, MHRA approved plants Including the World’s Largest Pharmaceutical Companies

Stability Testing Software for Pharmaceutical Industry

Stability studies are conducted in the Life Sciences industry to better understand drug product behaviour under various storage environments throughout its shelf life. Stability studies aid in ensuring the effectiveness of a product. Pharmaceutical industries place a high premium on product stability testing to confirm that they adhere to established processes and standards.

AmpleLogic’s Stability Management Software, built on our Low Code Platform is a comprehensive cGMP software designed to satisfy the demands of biotech, life sciences, pharmaceutical stability testing programs, and stability management.

Quality Metrics Software

Quality Metrics, often known as Metrics, is a tool used by the FDA to inspect products’ adherence to specific compliance standards and laws. It assists the FDA in appraising metrics for each product, as well as making comparisons between production sites and facilities.

To ensure that consumers get acceptable products and deliverables that meet approved standards, quality metrics play an important role in the overall quality management plan. It also assists companies in adopting a more safe and risk-free culture to avoid production issues or problems that result in the medicine not being pulled from the market.

Regulatory Information Management System (RIMS)

RIMS (Regulatory Information Management System) allows companies to team up, preserve application information data from various locations and enhance the processes of preparing a submission, as well as simplify the publishing and tracking of all regulatory activities that support a product’s complete life cycle.

Organizational regulatory information efforts begin with drug development to drug registration and commercial launch. Multiple divisions within a company are required to gather the regulatory data information required to supervise all processes in manufacturing, registering, and launching the drug. This information includes the design profile, ideas, technical information or specifications, and prototypes (if any). Many organizations currently keep and handle these operations using spreadsheets and paper records.

Regulatory Surveillance and Tracking Software

Pharmaceutical companies are subjected to many inspections by government agencies such as the FDA and MHRA. As part of the audits, observations are made in the following areas: production; packing and branding; material; laboratory controls; quality; and the facility. Case 483/Warning Letter/Import Alert/No Objection Certificate/Notice of Concern/GMP Trend are examples of typical observations.

AmpleLogic Regulatory Surveillance & Tracking Software is a versatile web-based solution that can be readily customized to meet any organizational requirement, allowing you to constantly assess and record compliance.

User Access Management System for Life Sciences

Corporate security relies greatly on User Access Management. A US FDA 483 Observation for Pharmaceutical and Biotech Companies may be issued in GMP environments if illegal access authorization is granted to application software and instrument software.

The number of automated applications continues to increase in the Life Sciences Industry. Among these various software packages are ERP, LIMS, LMS, QMS, DMS, eBMR, eLogs, and Chromeleon, to mention just a few. Several Cloud solutions are also available to them along with on-premise ones. It is not uncommon for major corporations to have between 100 and 200 software applications.