Digital Transformation: Why Is It Important for Quality?

Posted by Romeo Elias on Mon, Aug 06, 2018 @ 01:03 PM

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With the advancement of technology, more and more businesses are opting to undergo a digital transformation. It’s understandable, as it improves core business functions by making them more efficient.

However, there’s more to digital transformation than using apps that speed up a company’s processes. Innovation is an integral part of it — everyone wants an advantage over the competition which digital technologies might provide. Still, what all businesses need to understand is that digital transformation is also significant for Quality, and here’s why:

Shared Customer-Centric Focus

The end goal of digital conversion or any other IT initiative is improved end-user experience. Quality Assurance shares this focus as it aims to preserve good corporate reputation. However, that’s not the only goal of Quality Assurance — other than consistently good IT service and security for all users, QA needs to worry about the seamless launching of products and services. Staying ahead of the competition is crucial, but not at the cost of sufficient assurance of quality.

Importance for Innovation

There has been some discussion on what counts as “true” digital transformation. CIOs often merely digitally optimize their business, but they don’t transform it and innovate. It’s of paramount importance to have a good business vision when it comes to digital transformation, which is usually disruptive to the business or industry. Without QA to ensure business outcomes and a high level of customer value, that becomes even harder to accomplish.

Quality Challenges in Digital Transformation

Digital transformation covers plenty of different areas such as omnichannel solutions, IoT, and devices, mobile solutions, big data and analytics solutions, cloud services, etc. QA needs to adapt in all of these areas and provide the best customer value by focusing on eliminating some of the known weak points of each area.

For example, with mobile solutions, quality would have to work on improving the security and performance, while increasing functionality and making it all more straightforward to use than it’s ever been. To do this efficiently, QA would have to be able to test its solutions extensively — and that requires tools and expert staff.

How QA Can Meet a Company’s Digital Transformation Needs

Every QA strategy ultimately focuses on improving the end-user experience, which is what digital transformation is all about. However, working towards the same goals may not be enough. Business would still have to invest more funds into QA for it to keep up with the ever-increasing demands of IT advancement. Security and integration testing need to become a continuous practice, especially during the early stages of developing a system or software.

EQMS as a Way to Improve QA

A right way of ensuring that QA does a consistently good job throughout the entire process is using an eQMS to back up your digital transformation system. Despite the potentially high costs, if an eQMS is implemented well, it could make the process of digital transformation easier and improve your bottom line.

Our very own Intellect eQMS can quickly adapt to your company’s unique digital transformation needs. It’s an out of the box solution that can keep your workflow intact while making it possible for you to smoothly go through your digital transformation process and keep your QA on a high level.

Tags: digital transformation, quality challeneges, quality, eqms, Quality Management Software, Quality Management System, QMS

Benefits of Access: Capturing Quality Data on Manufacturing Mobile Apps

Posted by Romeo Elias on Wed, Mar 07, 2018 @ 09:33 AM

 

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The ability to use mobile devices on factory floors and laboratories is transforming many aspects of manufacturing in highly-regulated manufacturing industries such as pharmaceutical, nutrition, and medical.

Regarding healthcare, mobile devices have become so common that there’s been rapid growth in the development of medical software apps. These apps assist health care professionals in communications and consulting, data and time management, health record maintenance and access, patient monitoring, education and training, and even clinical decision-making.

Many manufacturing companies have seen how mobile devices have revolutionized the healthcare industry and are now also leveraging mobile technology with the intent to use them increasingly in the monitoring of production and to ensure factory efficiency and safety.

In the past, computing and communications meant having to rely on multiple devices which included pagers, PDAs, and cellphones that could only make and receive calls. With today’s smartphones, you have all the capabilities of those electronics in one device. But beyond the ability to make voice calls and send texts, today’s smartphones and tablets have browsers, GPS, sound recorders, and high-quality cameras. And most importantly, access to industry-specific apps.

With smartphones and tablets, you can now capture data and get quality assistance from ultimately anywhere. The ability to capture everything from deviations during sampling and testing to calculating batch measurements in real-time means that non-conformance and corrective actions can be enforced almost immediately. Also, having offline capability to still capture data on mobile if there is no internet connection can help with situations where the factory floor doesn’t have good reception on the mobile device.

In manufacturing, the significant benefits of allowing workers to bring their mobile devices to the floor are giving them the ability to contact other employees, communicate with off-site personnel, and reference manufacturers’ documents. With mobile technologies, there is a significant improvement in logistics and supply chain coordination with suppliers. Customer responsiveness is enhanced thanks to the capability to integrate mobile CRM systems with order management, pricing, and fulfillment.

This improvement in efficiency is saving manufacturers significant sums of money each year. It may seem trivial when you think about how the reduction in time wasted between capturing the information and relaying it to the relevant people is a matter of minutes. However, consider how much valuable time is lost every year when you add up all those lost minutes that ultimately equate to hours, days, and weeks of misspent time. This could have easily been avoided if everyone was equipped with a mobile device that allows them to deliver up-to-the-minute data.

Factory environments are also becoming increasingly safer as workers have access to relevant and real-time data which traditionally, was confined to a desktop in the control room. Access to real-time adjustments and improvement in supplier traceability of critical materials means having the most accurate information, ensuring extra levels of safety and enhancement in quality levels.

Highly-regulated manufacturing industries such as medical products need to be constantly calibrated. With mobile-based sensors, data is captured and reported in real-time to production, allowing quality engineering teams to immediately act and ensure the floor is continuously in compliance.

Thanks to these realizations, manufacturing landscape is changing and CEOs are embracing digital transformation, prioritizing the importance of mobile technologies in the form of mobile apps and integrating them in their strategies, procedures, and processes to increase accuracy and speed to production centers. The goal is to deliver better communication, promote collaboration, and increase responsiveness to deadlines and delivery dates.

 

Tags: mobile apps, mobile applications, quality, quality data, mobile web, Quality Management Software, QMS, Quality Management System

Software Compliance in Life Science Product Industries

Posted by Romeo Elias on Mon, Jan 08, 2018 @ 02:58 PM

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Operating a business in a government-regulated environment carries a high expectation of compliance and strict adherence to guidelines and policies. For companies that operate in the hyper-regulated scope of the Food and Drug Administration, software compliance is a top priority that must meet rigorously enforced standards.

There is no room for error in either medical or pharmaceutical software applications. The greatest concerns in each area focus on electronic recordkeeping and signatures (ERES) as mandated by Title 21 Part 11 of the Code of Federal Regulations.

 

WHO MUST COMPLY

Part 11 compliance applies primarily to medical device manufacturers and pharmaceutical companies. However, business operating in any of a number of life science product related industries must also ensure software compliance:

● Biotech and nanoscience companies

● Biologic and other drug developers

● Some cosmetic company applications

● Contract research organizations

There are few exceptions, but generally speaking, any company involved in the research, development, manufacture, or distribution of an FDA regulated product must be operating ERES software that complies with Part 11 guidelines.

 

FOCUSED ON RELIABILITY

Prior to cloud origination, digital conversion, and full-software integration, FDA regulated companies stored and submitted records in paper form. Hard-copy records carried a certain degree of reliability and trustworthiness necessary in the closely watched industry of medical and pharmaceutical development.

As technology advances, so have storage solutions and records. It is no longer efficient or economical to maintain volumes of paper when digital storage and filing are industry-wide norms. Twenty years ago, the FDA implemented Part 11 as part of an effort to standardize and regulate the quality, reliability, and trustworthiness of non-paper records, signatures, and filings with the agency.

Since the implementation of Part 11, software regulations have become an integral part of compliance issues and guidelines. When any company generates reports and signs off electronically, and submits digital documents to the FDA, it must comply with Part 11 regulations. Any software application used in the process must meet strict requirements.

 

SOFTWARE REQUIREMENTS

The FDA mandates a wide-range of complex and technical software requirements that individual companies must meet to comply with Part 11 rules. Since the accuracy and reliability of ERES data is the key focus of FDA concerns, software must include:

● Some validation process to ensure accuracy and identify altered or invalid records

● The ability to generate complete copies in various forms

● Security controls to limit access to authorized users

● Long-term storage and retrieval

● Appropriate training and tracking of electronic signature use

● Time and date stamped audit trails

In addition to these compliance requirements, companies must also have written policies regarding the use, control, and authorization of ERES systems among other strictly applied security and authenticity issues.

As technologies change and become obsolete more quickly, companies experience regular software issues and compliance questions. When evaluating software compliance, a good rule of thumb is for companies to exercise Part 11 software practices in any instance where records meet Part 11 definitions.

If your company’s software is out of date, lacks security and verification assurances, or has other compliance issues, it is time to find a solution. Ensure your company’s systems meet the latest Part 11 iterations and do not risk FDA sanctions because of a failed software audit.

Tags: FDA, regulatory, quality, validation, Compliance, Quality Management Software, QMS

Managed Workflow Equals Quality

Posted by Romeo Elias on Tue, Jan 02, 2018 @ 12:43 PM

 

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Managing workflow in any business or industry can be like trying to tame an octopus with its many tentacles, especially in today’s tech-centric production lines. However, effective workflow management and planning can do more than lead to efficiency and cost savings. It can also increase the success of data gathering and analysis in across the board quality management systems including CAPA and Document Control.

By keeping the right people in the loop and informed though a transition to digital workflow, your management team can improve information sharing and communication. Effective workflow management stems from a variety of practices and technological inclusions that replace older practices not designed to keep up with today’s rapidly changing business environments.

Get Back On Track Quickly

No business functions without quality and improvement. Systems like CAPA and Document Control benefit from improved workflow because information is disseminated, returned, and processed more quickly and accurately. When CAPA practices detect a regulatory anomaly on a pharmaceutical or medical device production line, efficient workflow enables a rapid correction to ensure a near instantaneous return to compliance.

Efficient workflow management reduces communication discrepancies and lags that may lead to production disruptions. When companies increase the reliability of delivered information and corrective planning and action, they reduce down time and the traditional non-digital evaluation period between a business process interruption and return to service.

Communicate Effectively with Team Members

One obstacle facing production businesses, especially those operating in remote and multiple sites, is ensuring that all team members have the latest and most accurate information regarding a company goal, directive, case management, or other time-sensitive communication. Information delivery provides feedback that leads to productivity, solutions, and drives quality control and customer satisfaction. A lack of shared information results in policy and procedural breakdowns that impair quality output and other business processes.

With employees working off-site, separate from management and quality control teams, the simultaneous delivery of information and management decisions ensures that your entire team functions as a unit. Some examples of synchronized information delivery accomplished through increased workflow management include:

  • Regulatory issues and updates
  • Workload assignments
  • Customer feedback
  • Task notices and deadlines adjustments

When every member of your team receives the same information, it eliminates the occasional system-wide hiccups that interrupt quality management, production, and output. Synchronized digital delivery eliminates the redundancy of paper copies and the need to file documents at a number of locations and offices when a single cloud-based alternative serves multiple recipients.

Keep Teams on the Same Digital Page

When a business relies on compliance and regulatory issues — such as FDA directives codified at the ubiquitous 21 CFR — every member of the quality control team needs the same up-to-date information at their fingertips. Communication among management personnel relies on integrated and autonomous workflow that includes delivery to key personnel who are aware of assigned tasks and problem solving procedures.

Effective business process management demands on-the-fly delivery, communication, and tasking. When a quality issue arises, you cannot afford to have team members thumbing through outdated manuals and regulations or not knowing their position in the QMS flow.

For businesses focused on strict regulatory compliance to critical standards, workflow management assures heightened responsiveness and effective quality performance. Eliminate lag times, outdated documents, and interactive missteps with an out-of-the-box QMS solution that incorporates workflow in both CAPA and Document Control modules. Should you wish to develop your workflow by customizing these modules or creating new ones, this is an ideal solution for your business.

Tags: Workflow, QMS, Hosted Workflow, quality, Quality Management System, Quality Management Software, Workflow Managment, Workflow and Business Process Management, Workflow Process Management, workflow automation, CAPA, Regulations, regulatory, Compliance, Customer Complaints, FDA, Document Control

QMS + WORKFLOW

Posted by Romeo Elias on Sat, Feb 11, 2017 @ 01:43 PM

Workflow Modeling and Automation

A core feature of Business Process Management is Workflow Automation.  This feature enables companies to describe their business process in a block diagram view, definding the flows, the roles, the activities, and business rules.  And once defined, the Business Process Management (BPM) Platform can automate and execute this workflow, notifying users when they are required to complete a task, providing them the information they need in context to complete the work, reminding them if they are late and keeping them up to date on the overall process status.  Managers can oversee the process in real time and be notified of any delays, audit the history and decisions that were made and ensure that everyone is following the company standard.

An Example Document Workflow
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The diagram above represents a document control workflow indicating the path the document followed, colored in green, to completion.

Most of the core processes in Quality Management Systems require workflow.  Document control is an obvious process where there are mutliple people collaborating together on the authoring, reviewing and approving of a document.  Workflow Modeling capability enables you to model your company's document control process, specifying all the roles, steps, rules, approvals, and decisions.  They system will then execute the workflow everytime a new document is created or is selected to be updated.  

One of the key advantages of this capability, as can be seen above, is a realtime view on the status of each document: where is it, who has it, how long has someone been reviewing it, was it approved or rejected, an so on.  A detailed and complete audit trail provides all the historical information necessary to pass any inspection or audit and to meet compliance with all ISO and 21 CFR standards.

In addition, the workflow model is defined by the company to meet their unique process needs. If the process changes, the modeler allows the company to very quickly update the workflow model so that it reflects the new process.  No programming or speciall skill sets are required.  Just an understanding of the company process and simple drag and drop.

Workflow capability is a very powerful feature to have in your QMS system.  Not only will it help you enforce your own unique company process, it also ensures everyone is following the right process, with full auditable history and visibility.

Do you have a Workflow Modeling feature in your QMS? Sign up today for a demo to see the power of Workflow + QMS. 

Tags: Workflow, QMS, Document Control, BPM, BPMS, Quality Management Software, Quality Management System, Workflow Managment, business process, Compliance

electronic signatures

Posted by Romeo Elias on Mon, Dec 12, 2016 @ 11:06 AM

After the advent of electronic record keeping and digitized business processes, the natural evolution for companies was to support electronic signatures.  The technological requirements to support this feature have been around for some time but the laws and regulations had to catch up.  Today, electronic signatures are very common and legally accepted in numerous industries to meet a wide variety of use cases and regulations. There are also many online signature tools like DocuSign and Adobe Sign (formerly EchoSign) that have become standard for applications in real estate, contracts, and insurance transactions.

Given the flexibility in interpretation of the applicable laws and regulations, there are many ways for business software systems to support electronic signatures.  Here are a few of the requirements you should consider when evaluating software options:

1. Association

Is the electronic signature associated with the specific electronic record or document that is being reviewed?  There has to be a technological and auditable way to link the electronic signature to the record.  This can be accomplished by taking a snapshot of the record when digitally signed and associating that snapshot with the signature.  It can also be accomplished by encoding the signature and other parameters to the specific document, i.e., inside the PDF or Word document itself.

2. Authentication

How do you ensure that the user digitally signing is authenticated? This can be accomplished in a number of ways.  Some systems rely on the user simply being logged in as a form of authentication and when digitally signing, the assumption is that it is the same person.  However, more stringent regulations like the FDA’s 21 CFR Part 11 require more verification that the user digitally signing is the same person and this can be accomplished by requiring the user to enter their password again at the point of digital signature to ensure authentication.  Some systems go further and require that the user maintain two separate signatures, one for the logging into the system and another for signing.

3. Auditability

How do you track and maintain a historical record of the electronic signature? Many systems provide a full historical trail of who signed the document or record and when it was signed.  Given the nature of electronic data and that it can be changed, some go further and track the exact information that was signed off on at the time of signature, so there is an exact record of what exactly was reviewed, even if the data changed later on.

Electronic signatures are critical for meeting compliance and for a comprehensive Quality Management System (QMS), among many others. In the not too distant future, electronic signatures will permeate all aspects of our lives.  I am sure the technology will evolve further and leverage other types of authentication and means of signature that we haven’t conceived of yet.

Tags: Paperless, Paperless Office, electronic signature, Document Control, QMS, Quality Management System, Quality Management Software, Workflow, BPM, Audits

Are You still customizing your QMS by modifying source code?

Posted by Romeo Elias on Mon, Dec 05, 2016 @ 11:21 AM

It is surprising how many companies today are solving their need to customize their Quality Management Software by modifying source code.  It is understandable why a company may want to customize a software to meet its unique business and quality processes.  However, software platforms have evolved so much that there shouldn't be a need to change or add code to the vendor platform.  Not only does this require expensive development skills and expertise, it also means that the company can no longer receive vendor upgrades to their platforms as they have branched out with their own custom solutions.

Intellect has built a full Quality Management suite on our award winning Business Process Management (BPM) platform, Intellect Accelerate, to solve this problem and provide many additional benefits.

  1. Below are just 5 of the many benefits of working with Intellect:

      1. 1. BPM Platform with No Coding Required

      2. BPM platforms are designed to enable companies to automate any business process. In addition, they are designed to enable constant changes to those processes. However, the process of automating a business process on a BPM platform does not require programming.  It is a drag and drop environment designed for business analysts and process owners. It enables them to control and make all the changes they want. They don’t have to rely on the vendor.

  2. 2. QMS Suite with Incredible Flexibility

  3. Intellect Accelerate is available with an out of the box QMS solution that includes all the core modules like Nonconformance Management (NCM), Corrective and Preventive Actions (CAPA), Document Control, Change Management, Audit, Training, Supplier Management and Risk Management.  But being built on a BPM platform means every one of these processes can be modified by the company to fit their unique needs and process requirements.  Companies can add, remove or modify data fields, change business rules, change the workflow model, create custom reports and dashboards, modify security settings and on and on.  All this can be performed quickly and through simple drag and drop, without programming or modifying source code.

  4. 3. Automate Much More Than Just QMS

  5. With Intellect Accelerate, you are not limited to just the QMS processes.  The platform enables automation of any business process.  This means you can expand and automate other processes like Customer Complaints and Returns, Project Management, Time Tracking, Expense Reporting, Capital Expenditures, HR onboarding, Employee Lifecycle Management, Inventory, Asset Tracking, Bug Tracking, Issue Management, Incident Reporting, Work Management and many others.

  6. 4. Always Access the Latest Release

  7. Despite all the configuration changes you make to the processes or additional processes you automate, you can always upgrade to the latest release, and get the latest platform tools, enhancements and bug fixes. You are not stuck with an outdated custom solution that can no longer benefit from vendor innovations because you have modified source code.  BPM is designed with the expectation that each company will configure its own unique processes and make changes to them.

  8. 5. Advanced Workflow

  9. BPM includes a core feature which is critical for compliance and audits – workflow management.  With workflow, you can model your process flows, assign roles and requirements, and easily track each process with status indicators, reminders, notification, escalations, reports and full audit trails. In addition, you can easily modify the workflow as your process changes and evolves over time.

  10. The days of customizing source code to modify quality processes to fit a company's needs are numbered.  Sign up today for a demo to see how easy it is to use and modify the quality processes built on Intellect Accelerate.

Tags: QMS, BPM, Workflow, Compliance, Document Control, Paperless, configurable, nonconformance, NCM, CAPA, Corrective Action, Preventive Action, Risk Management, Training, Supplier Management, Change Management, Customer Complaints, Audits, Quality Management Software, Quality Management System

8 Mandatory Elements of a QMS System

Posted by Chris Fisher on Thu, Sep 01, 2016 @ 01:31 PM

 

Managing NonConformance (NCM) is an integral part of an organization’s continual improvement plan. Intellect’s QMS Platform enables organizations to capture, track and maintain accurate, auditable nonconformance records through a centralized database to have transparency for departments, sites, or locations. This allows organizations the ability to exceed audit, nonconformance, and corrective and preventive action requirements of common standards including ISO 9001, ISO 14001 and OHSAS 18001.

Complaints Management software is needed for customer retention, compliance with industry regulations and avoidance of potential product liability lawsuits. Quality, compliance, safety, efficiency, and costs are impacted in addition to poor communication without a proper QMS in place. Intellect QMS includes change management, automation, version control, and workflows to communicate, acknowledge, and then implement any requirements.

Change Management software is imperative for closed-loop quality and requires automation, version control, and workflows. Intellect QMS integrates with any enterprise system, so full transparency is included in the change management process. The submission of change requests and control plan revisions can be included at any point in production.

CAPA (Corrective and Preventive Action) and product registration tracking are standard features to allow implementation of corrective and preventive actions. This will meet compliance with industry regulations including GMP, ISO 9001 and 14001, TSCA, REACH, etc. CAPA process workflows provide a controlled environment and reduce the risk of repeat issues by ensuring that defined CAPA solutions and processes are met.

Document Control/management organizes all documents into a centralized database with approval workflows and audit trails. This eliminates document redundancy, reduces the risk of manufacturing products with out of date SOPs, and creates efficiency in organizing documents.

Supplier Quality Management manages the process of qualifying, selecting, and monitoring suppliers and supply chain partners. Other requirements are supplier qualification workflows and tracking systems for supplier non-conformances and CAPA. Intellect QMS offers the flexibility and configurability to adapt to company specific business processes, requirements and needs. This allows organizations to define, track, manage, and report actions.

Audit Software reduces risk by enforcing consistent and harmonized processes while securely managing all information in a centralized system. In addition, it facilitates compliance with global government regulations and industry standards providing management the data needed to evaluate audit system effectiveness. It also provides auditors authoring tools required in the field.

Employee Training Software creates a single interface to develop and manage training initiatives organizationally. This allows enterprises to maintain a complete inventory of employee education levels, job descriptions and certification records. This will maximize the effectiveness of developing employee skills internally. Intellect QMS keeps employee certifications up-to-date as a full employee life-cycle enterprise management system.

If you’d like to learn more and create a QMS Proof of Concept app with Intellect, click here for a free trial. http://www.intellect.com/free-trial

 

Tags: QMS, Quality Management System, Quality Management Software, Document Control, Audits, BPM, Workflow, Training, Risk Management, CAPA, NCM, nonconformance, Change Management, Customer Complaints