QualityMaster

The Power of a Document Management System in the Pharmaceutical Industry

Sanjay Panjwani on February 21, 2024

document management system for pharmaceutical

“If it’s not written down, then it didn’t happen”.

Considering the context of our blog topic, this proverb fits perfectly. In the pharmaceutical manufacturing, documentation acts as a mirror to show what’s actually happening within the company.

Moreover, every pharma company must follow Good Manufacturing Practices (GMP). Equally important is the adoption of Good Documentation Practices.

Documents play a pivotal role in establishing consistency across operations and minimize the risk of misinterpretations and errors in communication, thereby ensuring improved product quality.

Adding to it is the need of managing hundreds may be thousands of formulas, both active and inactive along with their versions. Not to mention, regulatory bodies while inspecting a pharmaceutical manufacturing organization, precisely examines and validates all the documents and records, ensuring the processes, procedures, and products are adhering to the set industry standards, upholding the quality.

It is not overstating to say that in an industry like pharmaceuticals, where even a slightest error can have life-altering consequences for patients, documents act as the guardian of quality, safety, and compliance.

They act as the foundational stone for establishing quality management system in the pharmaceutical organizations.

However, a pharmaceutical manufacturing organization generates thousands of documents throughout the lifecycle of a product.

To manage such a huge volume of documents there should be a systematic and streamlined approach. And any system other than a document management system would succumb to errors and inefficiencies.

What is a Document Management System?

A document management system is defined as a systematic set of procedures and policies related to creating, capturing, storing, and tracking documents efficiently within an organization.

However, manual management of such a large volume of documents poses inherent risks and inefficiencies. Recognizing this, a crucial need for an automated document management software arises.

It eases the task of document management by providing a centralized, organized, and secured platform, enhancing efficiency of the tasks related to documents.

Features of an Effective Document Management Software-

An effective document management software encompasses a multitude of functionalities, elevating organizational convenience and streamlining operations.

Automating the Process of Document Management-

The software automates the complete document lifecycle right from creating to controlling, managing, organizing, and retrieving when required.

Moreover, it also manages multiple versions of documents separately, ensuring that only the Active version is being accessed by everyone.

Ensuring Timely Updates of Documents-

The software helps users to ensure that all the documents are up to date by providing alerts for expiry or whenever a document is due for revision/updates. It also sends notifications for release or pending approvals of documents.

Providing Easy Access to Crucial Documents-

By organizing all the documents at a centralized location, categorizing them based on file type, data type, and priority level, and allowing to search documents via metatags, a pharmaceutical document management software facilitates easy and quick access anytime, anywhere.

Ensuring Safety Through Access Control-

By enforcing access controls over the documents via passwords, a pharmaceutical document control software prevents from the risks of data theft or lost documents, ensuring tightened safety.

It also tracks all the activities performed on the documents, maintaining an audit trail of who and when viewed and modified the document.

Allows Effective Collaboration-

A robust pharmaceutical document management software enables such a capability that allows multiple people to collaborate and work on a common document without altering each other’s work.

Benefits of a Document Management Software-

When a pharmaceutical organization implements such an effective and capable document management software, it experiences immense benefits on multiple business fronts-

Benefits of Document Management System

Adherence to Compliance-

With an effective document management, a pharmaceutical organization will be audit-prepared every time with all the necessary regulatory documents, which will eventually lead to fewer compliance issues. This will even speed-up submitting documents for an Investigational New Drug Application.

Increased Operational Efficiency-

Today’s pharmaceutical industry demands an environment of agile decision-making and for this, critical documents accessibility plays a vital role. Enabling quick access to all the documents anywhere, anytime reduces the time usually spent on locating the required files, enhancing overall operational efficiency, and eliminating delays.

Maintains a Single Source of Truth-

By establishing a unified repository, a document management software for pharma industry ensures that all the stakeholders, researchers, and other employees access same information. This eliminates the risk of miscommunication between the departments that may arise when multiple documents are circulated.

Enhanced Security of Business Data-

Through role-based access, complete audit trail, and robust disaster recovery options, a document management software prevents loss or theft of data, ensuring high-end security.

Faster Time to Market-

A document management system (DMS) improves time-to-market by enhancing collaboration, ensuring version control, expediting approval processes, and facilitating quick document retrieval. With a centralized access to all documents of concepts and prototypes, automating workflows, and enhancing compliance management, a DMS accelerates the product development lifecycle, enabling faster delivery to market.

Final Thoughts-

Nowadays, pharmaceutical organizations that still relying on traditional (manual) practices of managing documents are likely to face a plethora of challenges.

So, implementing a document management software is the unavoidable need. However, choosing the right one is equally important for success. To your rescue come QualityMaster’s Document Management System. It proves to be the perfect choice.

It is a comprehensive Quality Management Software with having robust and effective document management module that not only offers you the aforementioned functionalities, but it also allows easy integration with other quality related modules like Change Management, Standard Operating Procedures (SOP), Risk Management, Audit Management, Training management, Complaint Management, etc.

What are the Different Methods of Document Version Control?

Sanjay Panjwani on December 7, 2023

In the fast-paced world of business today, document management is vital for productivity and compliance. Document version control, also known as versioning, plays a pivotal role in this process. It enables the tracking and management of document changes over time, ensuring accuracy, compliance, and seamless collaboration among team members.

Yet, managing versions manually can be cumbersome and prone to human errors, leading to version chaos. Document Management Software (DMS) makes things easier by putting all documents in one place, controlling versions, managing edits, and keeping track of changes. With DMS software, keeping documents up-to-date and compliant has never been easier.

Result: Smoother and reliable document management with 100% accuracy.

If you’re eager to explore version control, its best practices, and how DMS software simplifies it, then keep reading the blog. Something interesting is waiting for you at the end!

Table of Contents:

  • What is Version Control?
  • What do we need for Document Version Control?
  • Interesting Facts & Figures
  • Best Practices for Document Version Control
  • The Challenges of Managing Document Versions in a Manufacturing Business
  • What is Document Management Software and how does it help with Version control?
  • How QualityMaster Enhances Version Control?

What is Version Control?

Version control tracks different document versions and changes made over time. Imagine you are working with a team on a project. You are constantly updating and refining a document. This document could be a company policy or a research paper.

Version control tracks every change in a document, from the first draft to the final polished version. It records addition, deletion or modification, creating a sort of timeline or history. This is incredibly valuable, especially in collaborative efforts, because it lets you know who did what and when they did it.

Whether it’s correcting a typo, adding new information, or suggesting improvements, it ensures transparency in the entire document’s evolution, making it simple to review past decisions and understand why certain changes were made.

Version control is similar to a document’s diary. It records the document’s growth and assists in managing it effectively. Multiple individuals find this particularly useful when they are involved in its development.

What do we need for Document Version Control?

To successfully implement document version control, you should have the following elements in place:

  • Clear Versioning System: You’ll need a standardized way to label different versions of your documents. For instance, you can use numbers (like 1.0, 1.1, 2.0), letters (A, B, C), or a combination of both.
  • Audit Trail: A system that keeps track of and records all changes made to a document. This includes the person who made the changes, the time when they made them, and the specific changes that were made.
  • Access Control: Permissions and controls to limit who can edit a document, ensuring only authorized individuals can make modifications.
  • Storage and Retrieval: A secure place or document management system to safely store, organize, and easily find documents.
  • Collaboration Tools: Tools and features that make it easy for teams to work together on documents while still maintaining version control. For example, a check-in/check-out system can help prevent conflicts when multiple people are editing the same document.

Interesting Facts & Figures-

To illustrate the importance of document version control, consider these statistics:

  1. According to a McKinsey report, employees spend 1.8 hours every day searching and gathering information. On average, that’s 9.3 hours per week!
  2. In regulated industries like healthcare and pharmaceuticals, document version control is critical for compliance. Failure to comply with regulations can result in hefty fines.

For example, in 2020, the U.S. Department of Health and Human Services issued over $36 million in fines related to HIPAA violations.

Best Practices for Document Version Control-

Proper version control helps organizations maintain consistency, track changes, and mitigate errors. Here are some key reasons why implementing best practices for document version control is crucial:

Appoint an Administrator: Hire an EDMS administrator to oversee document management, compliance, and system maintenance.

Maintain Document History: Keep a clear version history to track changes and easily revert to previous versions, when needed.

Secure Documents: Use “check-out” features to protect documents from unauthorized edits and unnecessary revisions.

Member Controls: Implement precise access controls to restrict editing based on team roles.

Workflow Automation: Set up standardized workflows for tasks like watermarking, PDF generation, and electronic signatures.

Device Accessibility: Choose an accessible eDMS that’s interoperable from on computers, tablets, as well as smartphones.

Enhance Security: Implement encryption and backup plans to ensure document security and data integrity.

Integration: Connect your version control system with existing IT systems for better document management.

The Challenges of Managing Document Versions in a Manufacturing Business

The challenges that you might face while managing document versions manually are as follows:

Document version control methods

Production Blueprints:

In manufacturing, detailed blueprints and engineering drawings are essential. When manual version control is in place, it’s easy for errors to occur. For instance, using an outdated blueprint in the production process might lead to a costly error in the final product.

Example:

Imagine a car manufacturer working on a new model. If the team doesn’t use automated version control, they might use an old blueprint by mistake. This can cause design problems and delays in production.

Quality Standards: 

If multiple versions of a quality control manual exist, it can be challenging to ensure that workers are following the correct procedures, potentially leading to subpar products or safety issues.

Example:

Consider a food processing plant. Having multiple versions of the quality control guidelines can lead to workers being unaware of the latest safety procedures. This lack of knowledge increases the risk of contamination or product recalls.

Regulatory Compliance: 

Manufacturing businesses often operate under strict regulatory frameworks, such as ISO certifications or environmental standards. Failing to maintain precise version control can result in non-compliance and legal consequences.

Example:

In the aerospace industry, keeping track of the latest versions of documents related to safety and environmental regulations is crucial. Outdated versions could result in fines or even the suspension of operations.

Therefore, manufacturing companies often turn to automated Document Management Software to ensure precision, compliance, and efficiency in their operations.

What is Document Management Software and how does it help with Version control?

A Document Management System (DMS) is a digital tool that helps store, organize, and track documents. It ensures easy access, security, and version control. Document version control is crucial for managing information effectively within organizations.

It ensures that everyone works with the most current and accurate documents. Here’s how a Document Management System (DMS) enhances this process:

  • Accuracy: A DMS software maintains a single, updated version of each document, eliminating confusion caused by multiple versions circulating within a team.
  • Compliance: It tracks changes and provides an audit trail, simplifying compliance with industry regulations by ensuring documents adhere to necessary standards.
  • Efficiency: DMS software enables real-time collaborative work, allowing multiple users to edit documents simultaneously. It also preserves version history for easy tracking of changes.
  • Confidence: Employees can trust the documents they access, knowing they are the latest, approved versions. This confidence boosts productivity and decision-making.

Document Management Software automates these processes, ensuring documents are secure, easily accessible, and always up to date. One such automated document management system is QualityMaster.

How QualityMaster Enhances Version Control?

QualityMaster is a robust electronic Quality Management System (eQMS) that significantly enhances version control of documents and processes within an organization. Here’s how QualityMaster achieves this:

Enhances Version Control
  • Centralized Document Repository: QualityMaster provides a centralized repository for all documents, including policies, procedures, and work instructions. This ensures that all users access documents from a single, secure location, minimizing the risk of multiple versions floating around.
  • Automated Versioning: The system automates version numbering or naming, eliminating manual errors in labeling documents. It assigns version numbers or names consistently, making it easy to differentiate between document versions.
  • Access Control: QualityMaster allows administrators to define access permissions for users and groups. This means that only authorized employees can edit documents, ensuring version integrity and document security.
  • Version History Tracking: The system maintains a detailed version history for each document. It keeps a record of who made changes, when they made them, and the nature of the modifications. Users can easily review the document’s evolution and track all changes over time.
  • Collaboration Tools: QualityMaster facilitates collaboration among team members. Multiple users can work on the same document simultaneously, and the system seamlessly merges changes. This ensures that all contributions are incorporated into the final document.
  • Revision Control: The system enforces strict revision control, allowing organizations to manage document changes efficiently. Users can submit proposed changes for review and approval, ensuring that only authorized modifications are accepted.
  • Workflow Automation: QualityMaster streamlines document approval processes through workflow automation. This ensures that documents move through the approval chain smoothly and that the right individuals review and authorize changes.
  • Notification and Alerts: QualityMaster can send notifications and alerts to users when document changes occur or when approvals are required. This keeps users informed and ensures timely responses to document modifications.
  • Archiving and Backup: The system includes archiving and backup features, allowing organizations to retain historical document data. This ensures that previous versions are accessible if needed for reference or auditing purposes.

Concluding Thoughts,

So, are you ready to elevate your document version control? Take the next step toward enhanced accuracy, compliance, and efficiency with us. Contact today to learn more and start optimizing your document management process.

Feel free to write to us or visit our website to know more about it as well as our other products.

Why Automated Audit Management System is Important?

Sanjay Panjwani on October 11, 2022

Importance of audit management system
  • Overview
  • What is an audit? Why is it necessary?
  • Importance of automated audit management system
  • Conclusion

Overview

Before starting a blog about audit management, it is important to establish that the purpose of an audit is not to assign blame, but to find a solution. Many business owners and management personnel view audits as a necessary evil, a box to be ticked to satisfy compliance. However, in reality, an audit can add real value to your company. It can help you spot weaknesses in your infrastructure, expose non-conforming behavior and refine your business processes.

An audit ensures that all the steps of a manufacturing operation are being performed as intended. Manufacturing process audits should verify that procedures are properly followed, problems are quickly corrected, consistency of process is maintained, and there is continuous improvement and corrective action as needed. Companies can outperform their competition with the ability to take quick action on quality data gained from these audits and modify customer outcomes immediately.

Historically, the audit process was conducted manually with paper-based checklists. However, manual audits are no longer suitable in today’s digital age. Technology-enabled tools have taken over the responsibility of managing audit activities to ensure consistent quality and compliance. Regulated companies are increasingly using automated audit management systems to maximize effectiveness while managing costs and streamlining their audit process without sacrificing flexibility.

What is an audit? Why is it necessary?

An audit is the objective analysis and examination of a particular business operation to evaluate its conformity with the expected standards. Audits can have different purposes. A financial audit conducted to check the accuracy of the company’s financial records. Compliance audits are designed to ensure that the company is obeying the latest ISO 9001 standards. A quality audit checks for the application of predefined quality standards. These and many such audits can either be internal or external.

Types of audits

The procedure will depend on the type of audit being performed and the standards governing the auditor’s work. Audits are necessary as they can help the manufacturer pinpoint areas that need improvement. They offer a reliable assessment of the manufacturer’s capability and facilities and provide an overview of the company’s processes, operations, and workflows. Moreover, audits are valuable tools used to uphold employee safety, evaluate operational efficacy and uncover non-conformance issues.

Audit management system process

Importance of automated audit management systems

Technology aids in drastically reducing the cost of audits. Centralized operations and simplified reporting allow for accurate, actionable insights, so that auditors don’t have to waste time tracking down information in spreadsheets. An effective audit management system simplifies the day-to-day work by standardizing methods and automating repetitive tasks, hence boosting the performance and effectiveness of the entire auditing process.

An audit management software can plan, schedule, perform, report and close-out the process with automated workflows. It helps companies improve business performance by reducing risk and managing compliance. It also provides end-to-end functionality for the entirety of the audit life cycle which includes audit planning, checklists, data collection, audit reports and CAPA recommendations.

The key benefits of an automated audit management system are listed below:

Benefits of audit management system
  • Reducing Duplication – Conducting an on-site audit coupled with filling piles of duplicate data can be frustrating for the auditor. Using an audit management software, the auditor can gather evidence and answer questionnaires on the spot. With anytime & anywhere access, this software allows you to download the audit and attach relevant data as it is gathered. As a result, there is no duplication of effort, saving precious company hours or even days for every audit. The customizable report feature makes it easy to display data visually.
  • Data Accuracy – Writing notes or completing a paper-based checklist can be error-prone and bias driven. With an audit management system, auditors can capture real-time evidence and attach any type of common file including videos, photos and sound recordings. They can attach evidence of non-conformances that can be viewed by everyone in the same way, leaving no room for misinterpretation. The ability to collect data from different sources and applications reduces operational oversights and ensures a smarter decision-making system.
  • Pre-defined audit checklists – With an audit management system, companies can get pre-defined audit checklists. Audit managers can configure and add new fields in the checklist to suit business requirements. Standardization of processes and documents ensure the implementation of industry best practices. The checklist includes gathering preliminary information to scope the audit, determining the key business risks, identifying areas for more audit attention and informing managers about data needs.
  • Greater visibility – Audit management software has powerful reporting capabilities to provide greater visibility into critical audit results like findings, best practices & auditor recommendations. It also facilitates quick generation of detailed audit reports and distribute them to all the involved parties. Auditors can produce different types of reports for different types of audits, each providing you valuable insights. A unified dashboard of audit reports and results helps you make informed business decisions on the required improvements and changes.
  • Accurate compliance – Working from paper trails makes compliance difficult to prove – one missing file and you risk non-conformances or failing the audit completely. Audit management systems allow you to easily plan and schedule regular internal audits, with automated workflows triggered when a finding is raised. This makes it very easy to demonstrate commitment to regulations and other quality standards, delivering a full and comprehensive audit trail for anyone investigating your compliance.

Audit management solutions help enterprises align their critical processes with business quality objectives while mitigating operational challenges. They empower organizations by giving the more control and confidence in addressing compliance, quality, and operational risks efficiently through regular audits. One such software, QualityMaster prepares you to succeed with a next-generation approach to identify and eliminate inconsistencies throughout the quality system, products, and processes. If you want to automate your quality management activities with QualityMaster, click here.

Key Metrics That Drive Higher Manufacturing Quality

Sanjay Panjwani on February 7, 2022

key matrix of quality management

In all our previous blogs, we have discussed how quality is the most important attribute people look for in a product or service, and it is that predominant factor that decides the fate of products, services, as well as brands.

It is essentially why the business organizations across the globe focus on understanding the multi-layered concept of quality, and delivering it by inculcating a culture of quality within the organization, and integrating it throughout their operations.

This strategy of focusing on quality with the same intensity though each process, operation, and all the organizational resources helps them grow faster than their competitors, gain market share, and thwart price wars. And this holds true for organizations of all types and sizes…

…Including the manufacturing organizations

Quality gains greater significance in the manufacturing industry, where it is one of the biggest factors that determines customer satisfaction. Nobody wants to buy a product that’s prone to breakage, or might need to be replaced shortly after the purchase.

When we talk specifically about the process manufacturing industries such as pharmaceutical, food & beverage manufacturing, etc., within the broader manufacturing category, quality gains all the more significance, with the health of the consumers at stake.

Additionally, in these manufacturing businesses, poor quality of the products negatively impacts the manufacturing operations, as it can prove to be a costly proposition for the manufacturers to perform re-work on items that don’t meet quality standards.

Hence the need to drive higher manufacturing quality

More than any other industry, the manufacturing industry finds it paramount to maintain the quality standards of the products. In fact, it is one of their most essential responsibilities to ensure that the final output is safe, durable, and complies with all internal/external quality standards.

But when we talk about driving higher manufacturing quality, it is easier said than done. It may sound like an easy thing and a simple process, but in reality it is a complex thing to achieve. To begin with, it requires a thorough assessment of the manufacturing plant’s quality performance, which in turn relies on many metrics.

These metrics help identify whether you are producing a high number of quality products in the most efficient manner, and gain complete understanding of the current quality performance of your production facility while highlighting areas of improvement.

But, in the first place, what are metrics?

Manufacturing metrics or Key Performance Indicators (KPIs) are well-defined and quantifiable measure that the manufacturing businesses use to gauge their performance over time. These metrics can be defined as data and numbers that are indicator of a manufacturing company’s actions, abilities, and overall quality.

Organizations use these performance indicators to monitor, analyze, and optimize their manufacturing operations, and also to compare their efficiencies with those of their competitors. There are many different forms of metrics, and some examples include profit, return on investment, market share, customer satisfaction, customer reviews, and process excellence, etc.

These metrics are integral to an organization’s success, and hence it is important to track, manage, and eventually, improve them. Let’s understand the key metrics that can be measured, analyzed, and improved upon so as to drive higher manufacturing quality, in detail, and some others, in brief.

  • Metrics related to quality improvement

There are a few metrics that are directly related to quality improvement, such as yield, customer rejects/returns, and supplier’s quality incoming. Yield is the most basic quality performance metric for manufacturing businesses, as it reveals the percentage of quality products manufactured at a factory within a given time period.

Customer rejects/returns is a measure of the number of times customers reject or request a return for a product after it fails to meet the desired specification. Supplier’s quality incoming, on the other hand, suggests the percentage of good quality raw materials coming into the manufacturing process from a particular supplier.

  • Metrics related to customer satisfaction improvement

Customer satisfaction is another valuable measure of product quality. There are a few metrics that are a good indicator of the overall customer experience, and can help improve their satisfaction levels. Customer complaint is one such metric, which when tracked and addressed properly can throw light on areas of improvement and bring down quality control issues in future.

Then there are few other customer satisfaction metrics, such as your churn rate and the cost of customer acquisition. Then there’s also the ‘On-Time Delivery to Commit’ metric, which indicates the percentage of time when a completed product was delivered on the schedule that was committed to customers.

  • Metrics related to efficiency improvement

A few metrics such as throughput, capacity utilization, overall equipment effectiveness (OEE), etc. are a good indicator of an organization’s efficiency. While throughput measures what quantity of product is being produced on a machine, or plant over a defined period of time, capacity utilization indicates the total manufacturing output capacity which is utilized at any given point in time.

OEE takes into consideration availability, performance, and quality, and can be used to suggest the overall effectiveness of production equipment or an entire production line. Schedule attainment is yet another metric which indicates the percentage of time a target level of production is attained within a specified schedule.

  • Metrics related to compliance improvement

For an industry with so many moving parts, maintaining compliance is absolutely non-negotiable for manufacturing businesses. Hence, it is important for the manufacturers to track, measure, and manage key metrics related to compliance improvement, which eventually help drive higher manufacturing quality.

Metrics such as reportable health and safety incidents, which is an indicator of the number of health and safety incidents recorded in a defined period of time, and non-compliance events / year, a measure of the number of times a plant went outside the guidelines of normal regulatory compliance rules during a year, to operate, are also useful metrics.

  • Metrics related to cost reduction and profitability improvement

There are quite a few important metrics that impact cost reduction and improve profitability, and thus drive higher manufacturing quality. To name a few, ‘Total Manufacturing Cost Per Unit Excluding Materials’, ‘Manufacturing Cost As A Percentage Of Revenue’, ‘Net Operating Profit’, ‘Productivity In Revenue Per Employee’, and ‘Cash-To-Cash Cycle Time’, etc., are some of them.

Few more metrics that hold importance in manufacturing

  • Scrap rate
  • Cycle time
  • Demand forecasting
  • Inventory turns
  • Changeover time
  • Machine downtime rate
  • Inventory accuracy
  • Rework, etc.

QMS for manufacturing industries can help drive manufacturing quality

This list can still be expanded a bit further, depending on the need. But it should have given you a fair idea on what all metrics you should be measuring and monitoring in your manufacturing organization to make it a world-class manufacturing company that continuously strives for overall quality improvement.

Attaining higher quality levels has a tremendous effect throughout the organization, as everything is co-related. Reduced manufacturing cycle time improves order performance, which increases customer satisfaction, and in turn leads to more sales, reduction in cost of quality, as well as costs per unit of production excluding materials.

A good manufacturing quality management software such as QualityMaster can help your manufacturing organization drive higher manufacturing quality by executing the metric strategy, as well as all the quality initiatives from the top floor to the shop floor, to perfection. For any queries directed towards our in-house metric & quality experts, contact us here.