Electronic Quality Management Software (EQMS)

Life Sciences firms can only keep up with their rapid expansion, regulatory requirements, data integrity concerns, and surprise audits by using automated solutions.

Pharmaceutical and biotech businesses may easily manage their QMS processes using AmpleLogic Electronic QMS Software. As a result of recurrent efforts, manual document management and tracking can be time-consuming and labor-intensive. Because of this software, audits can be conducted more efficiently, and decisions may be made with greater confidence.

EQMS Software

AmpleLogic has created low code-based eQMS software with 9 key modules, focussed on addressing automation problems in Pharma businesses.

1. CAPA

CAPA Management Software

Every pharmaceutical company undergoes a quality system inspection method (QSIT), which involves an examination of the company’s CAPA system. Its requirements for FDA-regulated pharmaceutical firms are stated in 21 CFR part 11, which specifies that “each manufacturer shall establish and maintain procedures for implementing corrective and preventive action”.

Read More
2. Change Control

Change Control Management Software

Managing change is crucial in the life sciences industry. Pharmaceutical companies operating in GMP environments are required to disclose all changes. All changes must be approved by authorities before they can be implemented. Only after receiving clearance from regulatory agencies such as the US FDA and MHRA would a pharmaceutical organization make modifications to a current product.

Read More
3. Market Complaints

Market Complaints Management and Tracking Software

Customer Complaint Handling Procedures are regarded as a criterion of Good Manufacturing Practices in the Life Sciences Industry. Market complaints are usually about substandard or ineffective medications. These issues need to be addressed immediately, with a thorough examination and action taken to avoid a recurrence.

Read More
4. Audit Management

Audit Management Software

Pharmaceutical companies place a high value on auditing. Conducting GMP audits in the life sciences industry has the goal of determining whether or not Good Manufacturing Practices are being followed and making recommendations for any required changes. To assist pharmaceutical and biotech companies to improve their quality systems, audit checklists identify weaknesses.

Read More
5. Deviation Management

Deviation Management Software

Deviation management is a subset of the rules stated in good manufacturing practices in the life sciences industry. All deviations may be related to disparities between actual and expected or normal values for a process or product condition. Deviations require immediate attention, comprehensive examination, and immediate remedial action to prevent a recurrence.

Read More
6. Vendor Qualification

Vendor Qualification Management

Part of the standards established by international regulatory authorities such as the FDA, MHRA, and EU Annex 11 is for pharmaceutical and life sciences companies to create and design an Effective Vendor Qualification Management system that checks vendors and third parties who patronize their products globally.

Read More
7. Out of Specification

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.

Read More
8. Out Of Trend

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.

Read More
9. Lab Incident Reporting

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.

Read More

The most crucial component of Pharma Manufacturing Operations is QMS

Usually, this is performed manually by a key individual in the company, and the absence or neglect of this person influences the audit quality. Automation, thus, being a superior alternative, enhances efficiency and offers a better outcome on data integrity.

Our Enterprise Quality Management Solution is a COTS system that facilitates compliance and automates the whole process. There are quality criteria for the program, which provides for maximum control and transparency. The software also addresses quality concerns at their source, allowing pharmaceutical businesses to adapt and comply strictly with the rigorous requirements imposed by worldwide regulatory authorities. For example, the US Food and Drug Administration, the MHRA, and the WHO

CAPA Tracking, Change Control, Market Complaints, Deviation management, vendor qualification, audit management, OOS/OOT, document management, and training management alongside powerful automation with intelligent tracking are some of the modules found in the pre-configured Integrated Quality Management System (QMS)

Enterprise Quality Management Software(EQMS) system minimizes the chances of quality process failures, lowers the total cost, and improves organizational compliance.

Despite these benefits, are Life sciences companies ready to make an immediate shift from manual to automated processes?

AmpleLogic has created a low code-based eQMS software based on input from Pharma businesses on their automation problems as well as their work cultures. This program provides users with a comprehensive perspective of the Quality management process. With highly flexible processes, organizations may now easily control and comply with the most stringent quality requirements (such as 21 CFR part 11, EU ANNEX 11, and cGMP).

Due to AmpleLogic’s LOW CODE Platform, organizations may experience a seamless connection between modules, reduced rework, address data reliability, and Security with 21 CFR Part 11 and other GMP compliance standards.

Features of Pharma Quality Management Software

  • For each Quality metric, such as deviations, change control, CAPA, audit management, BOM releases and specifications, stability research activities, market complaints, and real-time achievement, AmpleLogic’s Total Quality Management System (TQM) software shows dashboards. The software is automated to provide a complete solution to access, record, and generate each function’s activity. However, there is the option to carry out these processes manually.
  • It is a web-based application that is available 24 hours a day, seven days a week, with access to a very safe centralized database and end-user access.
  • Improved process management and business communication with fewer user mistakes and no reliance on individuals
  • With automatic and programmed preemptive alerts, prompts, and escalations, you can ensure prompt authorization and closure.
  • All QMS procedures are initiated, approved, assessed, and verified online, using an electronic signature and an activity stamp.
  • Individual filtering options are available on a built-in notebook of the QMS electronic records.
  • It keeps track of workflows, processes, modules, and admin-level operations and records them in detail.
  • Communication with customers and regulatory authorities is simple and straightforward because of the built-in emailing feature.
  • Allows for simple monitoring of unit/department productivity and efficiency status through the use of KPI-driven evaluation metrics and traceability trends. This provides up-to-date graphical details such as pending work, work done, personnel responsible, and timelines in an appealing visual format.
  • An adaptable workflow, compliant with 21 CFR Part 11 and tailored to the customer’s procedure, is one of its key characteristics. Customizations might be made to the existing technique.
  • There are customizable triggers, email notifications, and escalation in this Pharma eQMS Software. A customer or regulatory authority can be notified of document evaluations and approvals based on established process stages.
  • Its adaptable QMS Architecture interacts easily with other systems such as ERP, SAP, LIMS, Legacy Systems, electronic batch record (MES), Document Management (DMS), Training Management (LMS), and others.
  • When it comes to internal and external audits, product releases, and needed modifications, the AmpleLogic Digital Quality Management System (eQMS) Software increases the response time.
  • It can provide statistics, record and analyze trends, and provide real-time informational reports utilizing an appealing visual representation that enables rapid decision making.
  • Because it is a web-based solution, geographical that restricts distribution is eliminated.
  • The Pharma QMS Software reduces repeated administrative work by automating workflow allocation and monitoring established procedures.
  • Through web-based access, the system provides openness and detailed traceability throughout the Integrated Quality Systems.
  • Its increased CAPA (Corrective and Preventive Action) capabilities provides a methodical approach to inquiry, process mapping, and problem management. It can also analyze the efficiency of CAPA.

Benefits of Enterprise QMS Software in the Life sciences, Pharmaceutical and Biotech Industries

  • In Life Sciences organizations, an efficient LOW-CODE Quality Management Software helps you to keep track of quality concerns across departments and makes it easy for you to address them. Duplicated or missing documents, as well as unregulated versions, are all eliminated by the eQMS Software.
  • It provides a centralized repository for quality records as well as recorded proof. This helps to keep the organization ready for assessment at all times. It also guarantees that records are retained and retrieved efficiently while conforming to retention regulations.
  • 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.
  • The Digital QMS Software offers quality metrics analysis and analytic patterns that are guided by KPIs
  • Because the business process is automated via customizable procedures, manual work is reduced.
  • The low code-driven development reduces the expenses of modification and approval.
  • When combined with Learning Management Systems (LMS), our Life Sciences and Pharma QMS helps ensure that each staff member receives the necessary education and training.
  • It shortens problem resolution times and boosts executive awareness.

The AmpleLogic QMS satisfies the electronic record standards of the TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH.

Our On-Premise and Cloud-Based Quality Management Software can also be used in the following fields:

  • Biologics
  • Medical Devices
  • Chemical
  • Contract Manufacturing
  • General Manufacturing
  • Food & Beverages

The AmpleLogic Electronic Quality Management System may help your company in a variety of ways. Please contact us for more details (eQMS).

Improve Quality. Increase Efficiency. Ensure Compliance.

Schedule a live demonstration now.

Request demo

Electronic Quality Management Software (EQMS)

Life Sciences firms can only keep up with their rapid expansion, regulatory requirements, data integrity concerns, and surprise audits by using automated solutions.

Pharmaceutical and biotech businesses may easily manage their QMS processes using AmpleLogic Electronic QMS Software. As a result of recurrent efforts, manual document management and tracking can be time-consuming and labor-intensive. Because of this software, audits can be conducted more efficiently, and decisions may be made with greater confidence.

Electronic Quality Management Software (EQMS)
Integrated Quality Management Modules

AmpleLogic has created low code-based eQMS software with 9 key modules, focussed on addressing automation problems in Pharma businesses.

1. CAPA

CAPA Management Software

Every pharmaceutical company undergoes a quality system inspection method (QSIT), which involves an examination of the company’s CAPA system. Its requirements for FDA-regulated pharmaceutical firms are stated in 21 CFR part 11, which specifies that “each manufacturer shall establish and maintain procedures for implementing corrective and preventive action”.

Read More
2. Change Control

Change Control Management Software

Managing change is crucial in the life sciences industry. Pharmaceutical companies operating in GMP environments are required to disclose all changes. All changes must be approved by authorities before they can be implemented. Only after receiving clearance from regulatory agencies such as the US FDA and MHRA would a pharmaceutical organization make modifications to a current product.

Read More
3. Market Complaints

Market Complaints Management and Tracking Software

Customer Complaint Handling Procedures are regarded as a criterion of Good Manufacturing Practices in the Life Sciences Industry. Market complaints are usually about substandard or ineffective medications. These issues need to be addressed immediately, with a thorough examination and action taken to avoid a recurrence.

Read More
4. Audit Management

Audit Management Software

Pharmaceutical companies place a high value on auditing. Conducting GMP audits in the life sciences industry has the goal of determining whether or not Good Manufacturing Practices are being followed and making recommendations for any required changes. To assist pharmaceutical and biotech companies to improve their quality systems, audit checklists identify weaknesses.

Read More
5. Deviation Management

Deviation Management Software

Deviation management is a subset of the rules stated in good manufacturing practices in the life sciences industry. All deviations may be related to disparities between actual and expected or normal values for a process or product condition. Deviations require immediate attention, comprehensive examination, and immediate remedial action to prevent a recurrence.

Read More
6. Vendor Qualification

Vendor Qualification Management

Part of the standards established by international regulatory authorities such as the FDA, MHRA, and EU Annex 11 is for pharmaceutical and life sciences companies to create and design an Effective Vendor Qualification Management system that checks vendors and third parties who patronize their products globally.

Read More
7. Out of Specification

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.

Read More
8. Out Of Trend

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.

Read More
9. Lab Incident Reporting

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.

Read More

The most crucial component of Pharma Manufacturing Operations is QMS

Usually, this is performed manually by a key individual in the company, and the absence or neglect of this person influences the audit quality. Automation, thus, being a superior alternative, enhances efficiency and offers a better outcome on data integrity.

Our Enterprise Quality Management Solution is a COTS system that facilitates compliance and automates the whole process. There are quality criteria for the program, which provides for maximum control and transparency. The software also addresses quality concerns at their source, allowing pharmaceutical businesses to adapt and comply strictly with the rigorous requirements imposed by worldwide regulatory authorities. For example, the US Food and Drug Administration, the MHRA, and the WHO

CAPA Tracking, Change Control, Market Complaints, Deviation management, vendor qualification, audit management, OOS/OOT, document management, and training management alongside powerful automation with intelligent tracking are some of the modules found in the pre-configured Integrated Quality Management System (QMS)

Enterprise Quality Management Software (EQMS) system minimizes the chances of quality process failures, lowers the total cost, and improves organizational compliance.

Despite these benefits, are Life sciences companies ready to make an immediate shift from manual to automated processes?

AmpleLogic has created a low code-based eQMS software based on input from Pharma businesses on their automation problems as well as their work cultures. This program provides users with a comprehensive perspective of the Quality management process. With highly flexible processes, organizations may now easily control and comply with the most stringent quality requirements (such as 21 CFR part 11, EU ANNEX 11, and cGMP).

Due to AmpleLogic’s LOW CODE Platform, organizations may experience a seamless connection between modules, reduced rework, address data reliability, and Security with 21 CFR Part 11 and other GMP compliance standards.

Features of eQMS Software

  • For each Quality metric, such as deviations, change control, CAPA, audit management, BOM releases and specifications, stability research activities, market complaints, and real-time achievement, AmpleLogic’s Total Quality Management System (TQM) software shows dashboards. The software is automated to provide a complete solution to access, record, and generate each function’s activity. However, there is the option to carry out these processes manually.
  • It is a web-based application that is available 24 hours a day, seven days a week, with access to a very safe centralized database and end-user access.
  • Improved process management and business communication with fewer user mistakes and no reliance on individuals
  • With automatic and programmed preemptive alerts, prompts, and escalations, you can ensure prompt authorization and closure.
  • All QMS procedures are initiated, approved, assessed, and verified online, using an electronic signature and an activity stamp.
  • Individual filtering options are available on a built-in notebook of the QMS electronic records.
  • It keeps track of workflows, processes, modules, and admin-level operations and records them in detail.
  • Communication with customers and regulatory authorities is simple and straightforward because of the built-in emailing feature.
  • Allows for simple monitoring of unit/department productivity and efficiency status through the use of KPI-driven evaluation metrics and traceability trends. This provides up-to-date graphical details such as pending work, work done, personnel responsible, and timelines in an appealing visual format.
  • An adaptable workflow, compliant with 21 CFR Part 11 and tailored to the customer’s procedure, is one of its key characteristics. Customizations might be made to the existing technique.
  • There are customizable triggers, email notifications, and escalation in this Pharma eQMS. A customer or regulatory authority can be notified of document evaluations and approvals based on established process stages.
  • Its adaptable QMS Architecture interacts easily with other systems such as ERP, SAP, LIMS, Legacy Systems, electronic batch record (MES), Document Management (DMS), Training Management (LMS), and others.
  • When it comes to internal and external audits, product releases, and needed modifications, the AmpleLogic Quality Management System (eQMS) Software increases the response time.
  • It can provide statistics, record and analyze trends, and provide real-time informational reports utilizing an appealing visual representation that enables rapid decision making.
  • Because it is a web-based solution, geographical that restricts distribution is eliminated.
  • The Pharma QMS Software reduces repeated administrative work by automating workflow allocation and monitoring established procedures.
  • Through web-based access, the system provides openness and detailed traceability throughout the Integrated Quality Systems.
  • Its increased CAPA (Corrective and Preventive Action) capabilities provides a methodical approach to inquiry, process mapping, and problem management. It can also analyze the efficiency of CAPA.

Benefits of Enterprise QMS Software in the Life sciences, Pharmaceutical and Biotech Industries

  • In Life Sciences organizations, an efficient LOW-CODE Quality Management Software helps you to keep track of quality concerns across departments and makes it easy for you to address them. Duplicated or missing documents, as well as unregulated versions, are all eliminated by the eQMS Software.
  • It provides a centralized repository for quality records as well as recorded proof. This helps to keep the organization ready for assessment at all times. It also guarantees that records are retained and retrieved efficiently while conforming to retention regulations.
  • 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.
  • The software offers quality metrics analysis and analytic patterns that are guided by KPIs
  • Because the business process is automated via customizable procedures, manual work is reduced.
  • The low code-driven development reduces the expenses of modification and approval.
  • When combined with Learning Management Systems (LMS), our Life Sciences and Pharma QMS helps ensure that each staff member receives the necessary education and training.
  • It shortens problem resolution times and boosts executive awareness.

The AmpleLogic QMS satisfies the electronic record standards of the TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH.

Our On-Premise and Cloud-Based Quality Management Software can also be used in the following fields:

  • Biologics
  • Medical Devices
  • Chemical
  • Contract Manufacturing
  • General Manufacturing
  • Food & Beverages

The AmpleLogic Electronic Quality Management System may help your company in a variety of ways. Please contact us for more details (eQMS).

Improve Quality. Increase Efficiency. Ensure Compliance.

Schedule a live demonstration now.

Request demo

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