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All You Need to Know About Quality Audits in the Pharmaceutical Industry

Chirag Panjwani on November 7, 2024

Audit management system for pharmaceuticals

Quality audits are very crucial in checking compliance with regulatory requirements in any industry. In a pharmaceutical setup, these audits check whether the complex processes and procedures of your pharmaceutical unit follow the set standard.

For examples, let us assume that your pharmaceutical company is making paracetamol to sell in the market. It is only through quality audits that your consumers, and regulatory bodies will have assurance that quality of your product meets the standard and therefore they are safe and effective to use.

Quality audits are very complex and time taking process.  But if you know how to prepare for quality audits, and how to be prepared for an audit, most of your worries will go away.

So, in this blog we will discuss all that you need to know regarding quality audit in pharmaceutical industry and will look into the ways to prepare for your next or probably the first audit.

What Is a Pharmaceutical Quality Audit?

Pharmaceutical quality audit is the systemized examination to check if your pharmaceutical organization follows the processes and procedures which are compliant to set standards. It also examines if the pharma company is producing products which match the set quality standards.  

These quality audits also give feedback to the organization and find out the scope of improvement in process, procedures, or quality of the product to meet the standard of the market.  

The entire motive of any pharmaceutical quality audit is to verify if the products being manufactured by the organization are safe to use for consumers or not.

Types of Audits in the Pharmaceutical Industry

Pharmaceutical industry will have three types of audits:  

  • Internal audit
  • External audit
  • Unannounced audit

Internal Audit – as an organization you audit your facilities, SOPs, other procedures frequently.  Internal audits help to keep the day-to-day work and procedures smooth and without flaw.

With the help of an audit management system, like QualityPro’s QMS software for pharmaceutical industry, you can plan internal audits by managing audit schedules, creating regular assignments, and sending out notification to the right set of people.

External Audit– External audits are conducted by external parties. It can involve independent organization, like notified bodies and authorities. With the help of a pharmaceutical audit management system like QualityPro, organizations can easily conduct external audits, make reports, and send recommendations, if any, for further improvement.

Unannounced audits– Unannounced audits can be conducted randomly by organizations or third parties. The more complex is your manufacturing product, the more frequent can be such unannounced audits.  

These are generally conducted to ensure that standard conduct and procedure following is in the DNA of the organization and it is not induced due to any audit requirement.

Ways in Which Pharmaceutical Audits are Conducted

There are three ways in which pharmaceutical audits are conducted:  

  • On-site audit  
  • Remote audit 
  • Self-audit

On-site audit– It is the audit in which third party auditor visits your organization and reviews documents, procedures, and processes. It will interview your staff, will see facilities and check if your organization meets the regulatory requirements.  

Remote audit– Remote audit is very similar to on-site audit but with an exception. Auditor does not visit the site physically but visits the site virtually and connects with the organization via video conference. There has been a surge in remote- auditing post and during Covid due to various physical restriction. Like all other industries, audit also went remote, and this practice has become very commonly acceptable now.

Self-audit– Self-audit is the audit conducted by a department personnel to check if the department functions as per the set standards of quality, adheres to various laws, and functions according to SOPs.  

Generally, these personnels are department heads who do self-audit. Self-audits are generally conducted frequently to make sure that all boxes of quality parameters are checked.

How to Prepare for Pharmaceutical Quality Audit?

How to Prepare for Pharmaceutical Quality Audit

Preparation to audits can avert various chaos at eleventh hour. Hence, it is always advisable to be prepared for it. Here is some check list for smooth audit preparation.  

Documentation–  

Review all the past audits. Based on that, prepare a list of documents which consists of (but not limited to)  

  • Batch records 
  • Master formula records 
  • Standard operation protocols 
  • Change controls 
  • Deviation 

These documents must be current and must be validated and arranged.  

At such point of time, an efficient pharmaceutical document management system such as QualityPro comes into use. With the help of such a tool, you can easily arrange documents, create new documents, digitize documents, and make various versions (while keeping old versions).  

Prepare an audit plan-

Prepare an audit plan and prepare a flow of the audit. This plan of action will be provided to audit inspector.  

QualityPro by TecWork helps you to plan, define and document audit objectives, including the scope, purpose, and goals of the audit.  It can also help to schedule different audits to execute in near future such as ISO and FDA as per your convenience.  

Conduct an internal audit-  

Internal audit will do a dry run before final audit. This will highlight any loophole in the process, procedure before the final audit. Remember to deploy an independent team for internal audit to make the audit fruitful.  

Tips to Make Auditing Smooth: 

  1. Make sure that all the key personnels are available at the time of audit.  
  2. Provide a separate room for auditor. 
  3. Be on time.  
  4. Maintain professionalism. 
  5. Take notes of auditing.  
  6. Answer auditor’s all questions honestly.  
  7. Provide only copies of documents and not originals.  
  8. Don’t leave the auditor with your documents and notes.  
  9. Conduct an exit interview with the auditor after the audit.  
  10. Soon after the audit is completed, prepare for your answer for any discrepancy highlighted by the auditor.  

Pharmaceutical Audit Management Software Solution: 

Pharmaceutical companies depending upon old paper and pen-based model struggle and face lot of challenges regularly.  

Recording on paper-based system is a very long and time-consuming process and generally it is error vulnerable. Documentation errors can lead to regulation non-compliance. This can be costly for the company in terms of money, brand image and time.  

With the help of audit management software like QualityPro, organization can remove error-prone processes and digitize documentation recording process. It can offer tighter safety protocols, maintain audit trails, streamline audit workflow, and help organization to analyze findings and act proactively.  

It offers an intuitive dashboard to get all audit related information like past audits, open findings, critical findings, CAPAs etc.  

QualityPro for Pharmaceutical Industry Offers Numerous Benefits Like:

  • It simplifies complete audit process 
  • Automates all time-consuming tasks saving time and resources 
  • Ensures compliance regulations 
  • Identifies potential risk and vulnerabilities 
  • Helps maintain integrity throughout the organization 
  • Pinpoint he grey areas in your organization that need improvement

To explore and discuss more on the benefits of QualityPro by TecWork for your pharmaceutical company or to explore how aptly does it fit to your unique requirement.

The Power of a Document Management System in the Pharmaceutical Industry

Chirag 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 QualityPro’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.

Ultimate Guide for Quality and Compliance Management 2024

Chirag Panjwani on January 4, 2024

Quality and Compliance are two pillars of a profitable business. How to ensure good quality of products and 100% compliance to norms? Take a dive to know.

Overview:

Quality and compliance, these are not just terms. For organisations these are mandates for existence. Although they have very little connection with each other on broad level, they are highly connected on a deeper level. They both impact the product as whole.

Consumers today are quality conscious. At the same time, they are equally concerned to know if the products they use follow the norms and standards or not. Therefore, these two attributes can make or break reputation of an organisation.

If quality and compliance are so important, then obviously, there must be some effective way to ensure that the organisation follow quality and compliance norms.

In this blog we will discuss quality and compliance at length. We will try to find out the possible Quality and Compliance Management Software which can help organisations to deliver quality product and yet remain compliant to the norms.

Stay on the page for full information.

What is Quality?

Quality refers to set of qualities expected out of a product or a service. It is a mixed effect of various factors like design, production, efficiency, safety, economy, timeliness and many more.

In other words, quality is a measure of how close it is to specific standards. It also stands for measure of how well a product or service meets its purpose.

What is Quality Management?

It is the process of overseeing the activities, tasks, and processes to produce each time a service or a product with set of expected quality. There are four components of it, namely:

  • Quality planning
  • Quality assurance
  • Quality control
  • Quality improvement

The process of implementing all four is called Total Quality Management (TQM).

What is Quality Management System (QMS)?

It is a system to document policies, processes, and procedures for achieving quality goals.

Since quality is a key differentiator in global market, implementing QMS is important to ensure that the processes run effectively and reduce cost for an organisation.

Benefits of Quality management system

Fundamentals of Modern Quality Management Systems:

Outdated QMS are complicated and have limited capabilities to cater to the present-day requirement.  Modern quality management systems are built on following fundamentals:

Unified application –

Fragmented and disconnected QMS system waste time and money. They put organisation at risk. Therefore, the QMS must have capabilities to unify all division of quality management, like document management, data analysis, training, and others.

One such QMS is QualityPro. This is a unified application having all the modules integrated and well connected with each other. QualityPro lets you:

  • Schedule training
  • Store and manage documents
  • Manage risk
  • Manage compliance and audits
  • Take corrective and preventive action

Visibility –

In the fast-moving business times, businesses must be aware of any significant risk right at the moment when they are happening, and not once the damage is done.

Modern QMS should include real-time visibility into all quality activities to eliminate delays in quality analysis.

QualityPro gives you a deep visibility. It lets you manage risk effectively. It is a full featured product designed to deal with unforeseen risk and help businesses to acquire a systematic approach to stay prepared against risks.

Based on visibility it provides, it flags nonconformance and allows you to take corrective and preventive actions to lower down such nonconformance in future. This way it mitigates possibility of triggering risk and nonconformance in future.

Control – Keeping important and sensitive data unprotected and accessible to everyone leads to many concerns. It can harm reputation of organisation and can cause financial loss.

Modern QMS such as QualityPro allows you to give conditional access to data, leaving away unauthorized access.  This way, it ensures data integrity.

Essential components of modern Quality Management Software Systems:

Essential components of quality management system

Modern QMS like QualityPro consists of all the above said modules, providing organisations surety of quality.

Now, as we have discussed quality, quality management and quality management system at length, let us steer towards compliance, compliance management and compliance management software.

What is Compliance?

In general, compliance means following to the rule. It is the state of being as per the guidelines. Definition of compliance also encompasses industry regulations and government regulations.

Companies and organizations today are being more and more compliance aware, because of increasing industry compliance norms, governments laws and consumer awareness.

Overruling compliance might result in huge penalties, cost reputation of the brand and deflect customers to competitors.

What is Compliance Management System?

There are various software which help you manage compliance with various regulations, standards, and legal requirement.

The software automates, consolidates, and streamlines an organisation’s compliance meeting processes. These are called Compliance Management System.

A compliance management system:

  • Manages compliance obligations of an organisation.
  • Automates various tasks in organisation, such as managing contracts or providing auditing tool for internal controls including documentation, report generation, etc.

Aim of a compliance management software is to provide staff with better visibility of compliance requirements and minimize possibilities of your organisation to be penalized.

Benefits of Compliance Management System:

Compliance management system has multiple benefits, like:

  • saving time by automating various processes like data collection, communication
  • tracking changes in compliance requirements
  • integrating the changed or updated compliance with the whole system

An efficient compliance management system like QualityPro (which is also an effective QMS) has many benefits, like:

  • Efficiently organise and manage information about regulatory environment of organisation. 
  • Easily identify which regulation apply to your organisation.
  • Automating repetitive tasks related to regulatory compliance across various departments of an organisation.
  • Saving from legal suites and penalties

QualityPro: Quality Management System or Compliance Management System?

QualityPro is a comprehensive Quality and Compliance management system. Loaded with the benefits of both, it is a Quality and Compliance software.

It is a modern software which makes sure that your products are good in quality and stick to the compliance.

By offering quality products, it helps attracting consumers and building brand image through its host of features like-

  • Supports food-related labelling and reporting requirements falling under FDA, FSMA, GMP, and such along with flagging of ingredients if their nutritional properties in formula exceed established industry standards.
  • Sticking to food labelling and reporting requirements, including GMP, FDA, GFSA requirements.
  • Supporting chemical related labelling and reporting including GMP, SARA Type III, REACH, HAZMAT, SDS, MSDS, INCI requirements.
  • Supporting special reporting of allergen and organic ingredients, as well as of Kosher and Halal products
  • Maintaining master batch records and other key audit records.
  • Graphical bi-directional lot traceability inquiries and recall reports.

On the other hand, by sticking to all the compliances, it is keeping penalties away from your organisation.

Thus, if you are a manufacturer and looking for a Quality and Compliance Management Software, QualityPro is a perfect solution.

To explore how it can benefit your organisation, feel free to connect to our sales team or visit our website.

5 Ways QMS Software will Transform your Food Manufacturing in 2024

Chirag Panjwani on January 4, 2024

Food QMS software trends in 2023

We are all aware that the food industry works with perishable products that directly impact the health and lives of ones consuming them. People may become unwell or become vulnerable to contamination if there is even the slightest lapse in the product’s quality. Thus, manufacturers must uphold quality standards and fulfil quality requirements before sending the products to market.

The narrative doesn’t finish here; this industry faces numerous other difficulties and obstacles, but it strives to overcome them in order to prosper. And their partner in this journey is food quality control software. Continue reading the blog to know more about it –

Overview:

Food production is one of the oldest, largest, fastest growing, but most complex manufacturing industry in the world. They operate on thin margins, deal with “increasingly aware” consumers, and issues such as labor complexities, complex supply chains, perishable inventory, and stringent regulatory & food safety requirements etc. These stringent regulatory requirements make it one of the most tightly regulated and controlled industries, and rightly so, as there have been a number of foodborne diseases reported in recent times, and the risk of contamination due to long, complex supply chains, has always been there.

In response to these challenges, FDA and other regulators seek for higher transparency in the food supply chain, and thus push manufacturers towards adhering to stringent industry regulations. This has made them look for solutions that can help them meet the industry-specific regulatory requirements, as well as maintain the food safety & quality standards.

And what can help them in this? Food Quality Control Software.

Food manufacturers have realized that QMS for food can help in combating the challenges related to managing critical quality operations, meeting compliance as well as standards, following ISO guidelines, and in turn, decreasing wastage and losses.

Benefits of using Quality Management System in food industry

A QMS offers document control, change control, training control, audits, CAPA, customer complaints, &
support for other quality processes.

Benefits of Food QMS system

5 ways QMS Software will transform your Food Manufacturing In 2024

Food manufacturers continue to put their trust on software for food quality control. And an efficient food quality management software can help them maintain food safety and quality. Knowing the fact that this software has tremendous potential to solve many problems faced by the industry, let’s know how it will transform the food manufacturing in a bigger frame:

5 ways QMS system will trasform the food manufacturing

Following compliances and regulation

Food industry is all about adhering to international standards as well as national laws, rules, and regulations. Doing it manually is an extremely time-consuming affair and often leads to errors and inaccuracy. However, a   QMS in food industry helps in staying in line with regulations and customs.

A food quality control software can prevent this mistake, ensure that the final product complies with all regulations which keeps businesses stay away from legal obligations and heavy penalties.

Preserving food safety and quality

Today’s consumers are increasingly concerned about the quality of the food they eat. They are keen on finding out about the complete supply chain for consumables, from farm to table.

Quality, food safety, and traceability all play a big part in this situation. A quality control software can enable producers to track each inventory item along the supply chain, perform quality checks at every stage, and ensure that there is constant, unobstructed visibility both forward and backward.

Syncing with the Go-green mission

By following the HACCP guidelines, it ensures maximum productivity by eliminating spoilage, reducing scraps and food wastages. In this way, our environment is also less polluted, and food producers can help contribute to being more environmentally sustainable and green.

Every quality process in the food business is automated and streamlined by a QMS, and as a result, the entire process becomes digital, eliminating the need for paperwork and an enormous number of files and folder actions. Only those with authenticated rights can access the central platform where the papers can be stored, modified, and secured.

Determining the issues & fixing them permanently

If non-conformances (deviations caused from the set standards) are not identified and handled on time, they can create chaos and havoc. For example: The mentioned ingredients of the food product don’t match the actual product.

A QMS in food industry, however, helps in determining issues like these and records them so that they could be fixed and ensures that the same issue never happens in future.

Improvement in supplier/vendor relationships

A QMS solution in food industry helps food manufacturers in evaluating & managing all aspects of suppliers that can have a direct impact on the product quality and also on, brand reputation. It brings every single detail of suppliers in a centralized manner and keeps all the departments on same page. It also helps in supplier verification and background checks.

How Can the Food Industry Benefit from QualityPro software for food quality control?

QualityPro – One of the best next-gen QMS tools for food industry that enables the food manufacturing organizations to achieve the highest-possible levels of quality, while maintaining the production efficiency as well as profitability.

Furthermore, it makes it simpler for the producers to comply with the regulatory standards by providing end-to-end visibility and traceability.

QualityPro software for total quality management in the food industry is a closed-loop quality system and has a variety of standard and unique features that enable food operators to manage all product quality, safety, and compliance issues throughout the production processes and into the supply chain.

Modules Included:

  • Non-conformance -Captures, manages, reports, and tracks, non-conformances from internal/external sources, and performs root cause analysis.
  • CAPA -Identifies quality-related issues, executes containment actions, mitigates recurrence, and verifies the effectiveness of root cause elimination.
  • Complaint Management –Manages and tracks quality-related customer complaints from investigation to resolution.
  • Training Management –Automates the paper-based training processes and tracks all the training records.
  • Change Management -Establishes a proper workflow for documenting changes and automates entire change control process.
  • Document Management –Stores, creates, tracks, retrieves, and manages organizational documents through the value chain.
  • Compliance Management – Automated alerts for potential issues and handle regulatory compliance with ease.
  • Risk Management –Assesses future risks and their impact and drive continuous process improvement through risk control and mitigation.
  • Audit Management –Automates and streamlines the entire audit process to plan, schedule, and conduct audits.

Click here to know how QualityPro can help your food manufacturing business!

Upsides of QualityPro’s Food Quality Management System

QualityPro is the preferred option for operators in the food manufacturing industry due to the following advantages to businesses:

Advantages of food QMS software

To sum up:

QualityPro comes with a strong Quality Control functionality and has been serving the needs of food manufacturing businesses successfully for over 30 years now. With this software for quality management in food industry, the food manufacturers can maintain the safety & quality of the products and meet the industry-specific regulatory requirements with élan.

To know more about its benefits to your food manufacturing business, connect with us.

What are the Different Methods of Document Version Control?

Chirag 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 QualityPro 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 QualityPro.

How QualityPro Enhances Version Control?

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

Enhances Version Control
  • Centralized Document Repository: QualityPro 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: QualityPro 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: QualityPro 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: QualityPro 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: QualityPro 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.