Electronic Quality Management Software for Pharmaceutical Industry
Rapid growth of Lifesciences companies, regulatory needs, data integrity issues, and surprise audits are forcing Organizations to adopt automated systems. AmpleLogic Electronic QMS Software helps Pharmaceutical and Biotech companies manage their QMS process with confidence. It enhances decision making, visibility, and supports preparedness for audits better than ever before. Manual document maintenance and tracking turns to be laborious and consumes time on repetitive efforts.
Quality Management is a critical aspect of pharma manufacturing operations and absence of the key person impacts the audit quality. On the other side automation improves process efficiency and gives better results on data Integrity.
But are the Lifesciences companies geared up to make an immediate shift from manual to automated processes?
After listening to the automation challenges faced by the pharma companies and understanding their work cultures, AmpleLogic has introduced a low code based eQMS software which offers an extensive view on Quality management process. It helps organizations control and comply with the most stringent quality standards such as 21 CFR Part 11, EU ANNEX 11 and cGMP with highly configurable workflows.
AmpleLogic Enterprise Quality Management System is Commercial-Off-The-Shelf (COTS), eQMS is a powerful solution that enables compliance, provides a holistically automated process control and transparency in the process according to a set quality specification. It also resolves quality issues at its root. This helps pharma companies adopt and adhere to strict stipulations set by global regulatory bodies like US FDA, MHRA, and WHO.
This pre-configured Integrated Quality Management System (QMS) comprises of various modules including CAPA Tracking, Change Control, Market Complaints, Deviation Management, Vendor Qualification, Audit Management, OOS/OOT, Document Management and, Training Management, with powerful automation with intelligent tracking.
Enterprise Quality Management Software (EQMS) System reduces the risk of quality process failures, lowering overall Costs and making the organizational processes more compliant.
AmpleLogic Electronic QMS developed on LOW CODE PLATFORM, allows seamless integration between modules reduce rework, address data reliability and Security with 21 CFR Part 11 and other GMP compliance standards.
eQMS Software Features
- AmpleLogic TQM software displays the dashboards for each Quality metric like Deviations, Change Control, CAPA, Audit Management, BOM Releases, Specifications, Stability study activity, Market complaints, real time performance
- AmpleLogic Total Quality Management (TQM) software will provide complete solution to access, record, and generate each function’s activity in automation. The option to carry out these processes manually will also be applicable.
- Quality Metrics should have dash boards showing Load, Initiation, Closure, Pending, repeat instances, Aging etc.
- 24*7 web-based application accessibility with highly secure centralized data base and end user access.
- Better process control & effective business communication with less human error and no human dependency.
- Assured Timely approvals & Closure with automated and predefined preventive notifications, reminders and escalations.
- Online Initiation, approval, assessments and Verification of all QMS processes with electronic signature and activity stamp
- Easy access on inbuilt QMS electronic records’ notebook with desirable filter options on individual level.
- Traces and details transactions on workflow, process, module and admin level activities.
- Smooth and easy communication with Customers and regulatory agencies with inbuilt emailing functionality
- KPI driven Quality Metrics reporting and traceability Trends to check the Unit/Department Productivity and Performance status that provide up to date graphical report like pending tasks, completed tasks, personnel involved, and time frames with eye catching visual representation
- 21 CFR Part 11 Complaint and Customizable workflows suiting to customer’s process and on the fly configurable changes in existing process.
- Flexible QMS Architecture integrates seamlessly with other ERP, SAP, LIMS, Legacy Systems, electronic Batch record (MES), Document Management (DMS), Training Management (LMS) and other systems.
- Provides configurable triggers, email alerts or notifications and reporting capabilities to Customer/ Regulatory body at defined workflows steps for appropriate document reviews and approvals.
- eQMS Software improves the response times for both internal and external audits, product releases and required changes.
- Capable to provide metrics reporting and analytical trending that gives real life informational reports with an eye-catching visual representation for quick decision making.
- AmpleLogic Pharmaceutical Quality Management System (QMS) is a web-based solution that eliminates geographical dispersion constraints.
- This Pharma QMS helps to reduce administrative recurring tasks by automating workflow distribution and tracking with defined workflows.
- It gives transparency with in-depth traceability across the Integrated Quality Systems through web-based access.
- Enhanced capabilities of CAPA (Corrective and Preventive Action), enabling systematic approach in Investigation, Root Cause Analysis and resolution of your issues. It can also track CAPA Effectiveness.
Benefits of Enterprise QMS Software in Lifesciences, Pharmaceutical and Biotech Industries
- An effective LOW-CODE QMS Software allows you to record quality issues of different departments in Life Sciences companies and makes it easier to solve those issues
- eQMS Software eliminates the issues such as duplicate or lost documents, and uncontrolled versions.
- A single source that contains quality records along with documented evidence will help to maintain the organization inspection-ready state all the time. It ensures efficient record retention and retrieval process while adhering to retention policies
- AmpleLogic Pharmaceutical QMS Software with its advanced capabilities provides data from different sources to help the quality unit and management identify a root cause among SOP changes and suggest immediate changes necessary to maintain product quality.
- AmpleLogic Pharmaceutical QMS Software provides KPI driven Quality metrics reporting and analytical trends.
- Our Life sciences and Pharmaceutical eQMS Software can work along with LMS systems to ensure that each staff member receives appropriate learning and training.
- Reduce manual effort by automating your business process through configurable workflows
- LOW CODE driven development minimizes the cost of change and validation efforts
- Improve problem resolution time frames and increase executive visibility
AmpleLogic QMS complies with electronic Record standards defined by TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA and MoH.
Other Industries that can benefit from our On-Premise and Cloud Based Quality Management Software
- Medical Devices
- Contract Manufacturing
- General Manufacturing
- Food & Beverages