A leading technology firm in the United Kingdom (UK) once set out to find out the single-most important attribute customers desired from a product or service. What followed was a global survey conducted across the United States of America (USA), Europe, and Asia.
The results of that survey uncovered quality as the top attribute users demanded for, with 30% of respondents stating it to be the most important attribute. At 24%, reliability was the second most valued attribute. And as quality essentially drives reliability, it is fair to say that more than half of the respondents felt that quality is an indispensable and integral part of any product or service.
Such is the significance of quality that it translates into customer’s trust, and eventually higher sales numbers. Whereas, its absence from a product or a service may lead to a brand losing the customer for good. No wonder, quality is the most crucial aspect any business must focus on to ensure its success.
Quality- the most important facet for pharmaceutical industry too
When it comes to pharmaceutical manufacturing industry, which happens to be one of world’s most highly-regulated sectors, the significance of quality goes several notches higher. Quality is not a choice, but a prerequisite to be in this industry, and hence quality management becomes quite important because of the functions involved and a lot being at stake — including life.
In pharma industry, the poor-quality drugs or medical devices can put one life to risk, and hence managing quality right from the initial stage of manufacturing becomes paramount. Sourcing the top-quality raw materials & ingredients for manufacturing, adopting & following the industry best practices for manufacturing, and ensuring quality even after production is integral to pharma manufacturing.
By managing the quality throughout, pharma manufacturers can minutely scrutinize their processes and products, track even the slightest of deviation, and ensure quality at every level of manufacturing to develop effective and reliable products of highest quality.
And, a quality management software (QMS) helps make it possible
An efficient QMS software for pharmaceutical industry is basic infrastructure needed to build Quality culture in the organization. It can help the pharma manufacturers in a lot of ways. To begin with, it can manage all the records, workflows, and processes in a certain order that helps the manufacturers ensure the products meet the requisite safety and quality requirements.
By helping manage quality, a QMS system in pharma can make the life less stressful for the pharma manufacturers by reducing the risk of poor quality, and product recalls, and by facilitating better decision-making. Besides, it can also help manufacturers deal with some of their biggest challenges such as handling the increasing regulatory demands, and improving manufacturing performance, among others.
And how exactly does a quality management system in pharmaceutical industry make it possible? The answer lies in its essential elements. Let’s understand them at length to get a better idea of the crucial role played by the QMS in pharma.
The most essential element of a QMS in pharma happens to be the Quality Control (QC) module. It allows creation and storage of QC tests with target values for particular items/item group. Through it, the management can set tests at every step of the value chain- i.e., when the materials come into the facility, when they are used for production, and at other instances.
Manufacturers can ensure quality at all stages by managing the records of passed/failed tests, accepting/rejecting the product based on inspection result, and initiating actions like recall, destruction etc. against the items that fail inspection. The best ERP for pharmaceutical industry quality control also empowers the manufacturers to access information on how many times the test has been executed, performance of the test case, its status, and generate customized Certificates of Analysis (CoA) etc.
Nonconformance (NC)& corrective & preventative actions (CAPA)
A good quality management system in pharmaceutical industry also features NC and CAPA as essential elements, which enable tracking non-conformance and performing CAPA for rejected materials. This is made possible by allowing the documenting of every product issue identified during the process of quality check, and proceeding with right corrective and preventive actions for the valid non-conformance issues recorded, while directly terminating the invalid ones.
The training module effectively manages the training process, and tracks training records to ensure that the employees are adequately trained. It also helps organizations perform analysis of current or future training needs and cost by keeping the employee and training records up to date and compliant with their quality system.
A vital part of the QMS system, it automates and streamlines a pharma business’ paper-based training systems, and offers a host of benefits such as it increases business’ efficiency by automating the management of all training tasks- right from scheduling to completion. Businesses can organize/schedule/ training, manage certifications, develop training curriculums, define evaluation methods, and store results, records and history- all in one platform.
Another important element of a QMS in pharma industry is the audit management functionality, which helps organizations to manage and control their audit operations. It provides the pharma companies with a methodical flow of functions including creation, scheduling, preparation, execution, tracking, and following-up of their annual, half-yearly, and quarterly audits accurately and timely.
Another critical element of a QMS system in pharma happens to be documentation (SOPs, procedures, policies, etc.) management, which directly influences product safety and quality. It may include information about the right dosage for different age groups, how to take the medicine, and most importantly, how dangerous it can be an excessive amount.
A QMS software for pharmaceutical industry stores, creates, tracks, retrieves, and manages all types of documents, allowing the manufacturers to keep all such information documented at one place so that it can be released with the product, by offering guidelines and rules for storage, copying, access & permissions, version control of the electronic records, etc.
The compliance management feature of a quality management system in pharmaceutical industry allows the manufacturers to monitor and record the manufacturing activities in real-time and check whether they are in accordance with the norms of FDA and other regulatory bodies such as Good Manufacturing Practice (GMP).
Additionally, it also helps pharma companies comply with 21 CFR Part 11, the guideline that applies to all FDA-governed industries for electronic records and electronic signatures, and all other local, regional, national, or international regulatory requirements.
The complaint module of a QMS in pharma streamlines the entire complaint resolution process. Right from maintaining to investigating the complaint, then communicating the resolution back to the customer and finally closing the issue – it allows smooth and hassle-free conduct of the processes in an easy-to-use environment. This helps manufacturers ensure industry and regulatory compliance, improve product quality, and reduction in fines and costs associated with customer complaints and resulting recalls.
The change management module allows companies to establish a proper workflow for documenting the changes. Through it, the manufacturers can automate and manage every step of the change control process- right from initiating change requests, through impact evaluation, actual implementation, verification, approval to closure.
Additionally, it offers the organizations a way to set-up department-wise approvals, besides providing real-time notifications and validations for approvals, change executions, implementations, closure, and training. This helps the pharma businesses meet FDA and Quality System requirements thereby enabling to achieve change management objectives seamlessly.
All the essential elements of a quality management software for pharmaceutical industry you just read about are a must-have for any pharma manufacturing organization in the current business scenario. A good QMS system in pharma, possesses all these elements, and more.
BatchMaster QMS is one such end-to-end solution that facilitates enterprise-wide transparency and collaboration in managing quality initiatives for the pharma businesses. Available as a standalone QMS solution, it can also be integrated with BatchMaster ERP solutions, and even its desired modules can be completely integrated allowing swift movement of data from one module to another.