Breaking Boundaries: Achieving Superior Quality in Pharma through an Advanced Management System

In this fast-paced world, “recovery” from an illness stands on the second ladder, while “faster recovery” is on the first.

Increasingly pharmaceutical organizations are striving hard to make newer innovative versions of existing medicines that are safer, better and faster in treating illness.

To formulate and effectively develop such medicines, organizations need to make substantial changes that not only help them achieve faster results, while meeting top quality standards, but also helps stay compliant with the regulatory norms.?

In this blog, we will discuss how pharmaceutical organizations can break the boundaries of “recovery” and achieve superior quality to attain a “faster recovery” stage while staying compliant with the norms. We’ll highlight the role of advanced management systems in this journey of transition.

What is an Advanced Quality Management System?

Advanced Management System is the workflow that manages every aspect of pharmaceutical operations, processes, and resources. It ensures that all parts of the organization are at a required level quality-wise.?

Need for Advanced Management Software in the System:

The software that documents these systems and keeps them accessible in a controlled manner at a centralized hub is known as modern Quality Management Software. One such software is BM QualityMaster.?

Every organization has various departments. Each department has a lot of documents like policies, contracts, workflows and many other documents to handle and store. Keeping them organized is a compliance mandate as well as a mandate for the smooth functioning of the organization.

An advanced management software or say advanced quality management software helps organizations to manage these documents, formulate new documents, identify nonconformance (which is a deviation from the standard result), take necessary corrective and preventive actions, and instill a culture of continuous improvement in the organization.?

In other words, an advanced Quality Management Software helps organizations to make products of superior quality that are compliant with the norms.

How Advanced Management Software Helps in Achieving Superior Quality?

A Quality Management Software is equipped with various modules. These modules help the organization to document actions and activities of various functions related to the organization.?

By documenting and analyzing these activities, organizations can advance to provide better quality output.?Following are some modules of these advanced Quality Management Software in pharma to help organizations produce superior quality results:? ?

Document Management Module –?

Every organization has multiple documents to store. These documents are related to certificates, licenses, approvals from government, contracts, MOUs, etc.

Arranging these documents in a systematic and ‘easy to fetch’ way is critical for pharmaceutical organizations.

The advanced QMS in the pharma manufacturing industry not only helps to arrange and store these documents systematically, but it also provides access to various departments as and when required.

Hence, organizations never miss or lose any important document, can update documents from time to time, refer to these documents as and when necessary, and follow the laws and regulations to produce goods.?

These standard documents become the blueprint for organizations to prepare customer-centric medicines in a way that is beneficial not only for consumers but also for the organization.

Moreover, having a systematic arrangement of these documents makes the process and organization follow stringent regulatory and compliance laws.?All these together lead to a quality output and this superior quality in pharma.

Non-Conformance Module?-

Pharmaceutical organizations must function towards zero error vision. Yet, there are instances when the function of a department deviates from the defined standards.?

Advanced pharma QMS software provides features to document and register these deviations. Registering and preserving such nonconformances help in two ways:

1. It acts as a reference for future non-conformance (NC). If the same or similar NC triggers in the future, an organization can refer to the present one.
2. It helps organizations to detect nonstandard products beforehand. This proactive approach saves further process with the deviation and helps an organization to stop sending the final, deviated from standard product into the market. This helps to save probable nasty repercussions against the organization.

The documentation of NC also helps an organization to rectify its process and function and make such arrangements which will avert the recurrence of the same NC. This builds up a culture of continuous improvement and thus superior quality.

Corrective and Preventive Action (CAPA) -

Only detecting the deviation from the standard is not sufficient. Organizations must find the root cause of this deviation and rectify the issue to ensure quality output.?

Hence, before correcting the error or even attempting the correction, the organization must find the root cause.

This module enables businesses to register and analyze the root cause of the deviation. Basis the root cause, an organization can take necessary corrective actions.?

For example- Suppose in a tablet of paracetamol, the content of paracetamol is found to be less than the required. The root cause of this deviation was the inaccurate calibration of machines used to mix the salt.?

Upon finding this, the company must document it and take necessary action to correct this fault, which is to repair the machine for correct calibration.

Now once the corrective action is taken, it is time to ensure that the same fault or error does not trigger in the future again. Hence, the organization will go for Preventive action.?

Organizations must analyze the preventive actions and document them too.?

This documentation of action, its feasibility, its impact on the department, and expected output will be stored in the CAPA repository and will act as a reference for future triggers.?

With the help of CAPA, pharma organizations can not only correct the current errors but also anticipate future ones and can take necessary actions.

With each NC and CAPA, the organization becomes better and better in its process and procedures, thereby nurturing the culture of superior quality production.?

Change Management Module?-

Issues and problems are the origin of growth. True for the pharma industry also. Once an organization predicts an issue, it will document CAPA. Actions described in CAPA will bring meaningful change in the process, or documents to ensure that the same error is not triggered in the future.?

Hence, the change management module will register the proposed change, impacting the department, the cost of the change, and the expected outcome of the change.?

With the help of this module, all concerned can immediately be informed about the viable change, ensuring its timely implementation which ultimately leads to better processes and in turn quality.

Risk Management Module?-

The module acts as a visualizer for the organization. It can assess probable risks that can occur in the present or in the future.

For example, if a gel capsule leaks and liquid or salt comes out then what will be the consequence, how to curb it, how to handle and identify it???

Advanced QMS software like BM QualityMaster helps to record, assess, avoid and mitigate risks. It even generates a risk scoreboard highlighting risks that need immediate attention.

When risks are easier to analyze and find, its mitigation becomes faster, which leads to better quality processes and products.

Audit Management Module?–

In any pharmaceutical industry compliance and integrity are paramount and these are ensured by Audit.?

The audit Management module of BM QualityMaster QMS software helps pharmaceutical organizations to stay audit-ready. With the help of this module, pharma organizations can conduct internal as well as external audits swiftly. Right from making an audit checklist to defining different audit classes like internal, external, remote, etc., advanced QMS software like BM QualityMaster facilitates all.

An audit-passed medicine is quality-wise superior, compliance-wise abiding, and therefore always market viable.?

Training Management Module –?

With the changes in types of diseases, organizations need to upgrade and innovate. Also, they need to catch up with the changes in the market. To make their employees competent enough and to mold them as per the latest pharmaceutical trends, organizations must train their employees.

The training module of a QMS software like BM QualityMaster helps organizations to design training courses, identify training requirements, design training schedules, create training batches, select the apt trainer, generate training certificates, and track the training of the staff.?

With proper training, staff can be more prepared for changes in the market, and they can uplift their efficiency to make better and superior quality drugs to help people live a healthy life.?

Complaint Management Module?–

Complaints are feedback from consumers or internal stakeholders. Organizations that listen to this feedback and handle complaints effectively are the ones that grow.?

With advanced QMS software, organizations can register complaints, sort them as per their severity, assign personnel to resolve them, and add notes and details of the complaint.?

This accelerates complaint resolution speed and hence, creates a happy customer.?

Also, sometimes, these complaints might bring some ignored or neglected areas of the pharmaceutical business to notice.

Highlighting this ignored area will improve the quality of the drug, procedures involved, or processes followed which eventually will positively impact the quality of the medicines as final output.?

Final Thought:?

The pharmaceutical industry is overly sensitive. It has a widespread impact and therefore organizations aspire to produce superior quality of drugs to not just stay on top in the market but to keep away fines, penalties and brand defamation.?

In such a competitive market, an advanced QMS software like BM QualityMaster helps these organizations bring quality drugs to the market.?

BM QualityMaster brings all essential QMS modules under one roof. The software is easy to use and implement. With numerous users worldwide, BM QualityMaster is an apt solution for your quality management needs.?

To know more about it, visit?BM QualityMaster.