6 Tips to avoid 483 letters

Posted by Peter Hargittay on Wed, Nov 28, 2018 @ 02:40 PM

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The U.S. Food and Drug Administration (FDA) is authorized to perform random inspections and audits, and these inspections can lead to FDA warning letters and FDA Form 483 observations. Quality managers must take several proactive steps to reduce the risk of warning letters, but what exactly should be done, besides the obvious, which is to be in compliance with defined regulations?  

First, let’s define and understand the meaning of warning letters and Form 483 observations.  Warning letters are considered to be informal and advisory by the FDA.  Nevertheless, organizations are expected to voluntarily comply with the law and to take corrective actions.  The FDA Form 483 provides support for the alleged violation and communicates the concerns discovered during the inspection.

Organizations are given an opportunity to voluntarily and promptly respond in writing and include a corrective action plan.  However, if issues highlighted by the FDA are not addressed and communicated in a timely manner, the FDA will initiate an enforcement action, and these actions can include product recalls, fines, penalties, and, of course, your reputation is at stake.

Here are some tips on how to avoid a warning letter and  form 483 observation:

  1. Be inspection ready

Have a QMS in place that meets your operational needs and compliance requirements, conduct your own internal audits on a regular basis, identify audit team members and assign tasks, provide a schedule of meetings, identify confidentiality requirements, and involve senior management.  Inform your employees about audits, provide resources needed, and appoint staff to accompany auditors when they do arrive.

  1. Clearly Written Standard Operating Procedures

The Standard Operating Procedures (SOPs) need to be clearly and concisely written, but also maintained by getting them modified when necessary. Make sure you document any changes and that only the most recent version is available to your team and to inspectors.  

  1. Proper Document Control

An automated document control system provides proper version control of your documents, including SOPs.  Your document control should eliminate the possibility of human errors and provide standardization to your version control, revision history, and approval process.  Establish proper permissions to prevent unauthorized access and changes to your documents.

  1. Develop a compliance culture

Make quality and compliance a cornerstone of your culture.  A corporate culture is often driven by the organization’s CEO.  You need your CEO and executive team to be on board, and to understand and communicate the importance of compliance and quality to the entire organization.  One way to ensure senior management involvement is to actively involve them in the initial meeting of an audit, during the audit process, and in the final meeting.  Make sure to keep senior management involved with all subsequent communications with the FDA.

  1. Correct observations real-time

Take every effort possible to correct observations while the FDA investigator is still onsite and express that remaining issues are in the process of being addressed, ideally with a stated timeline.  It’s important to communicate these changes or planned changes before or during a close-out meeting, and before the FDA inspection report is completed. Remain professional, provide proof whenever possible, and keep copies of signed-off documents.

  1. A hyper-adaptive Quality Management Software

QMS software has evolved from customizable solutions that are typically expensive, time consuming, and with limited configurability capabilities to quality automation software that empower users with tremendous flexibility and at a lower total cost of ownership.  A modern and hyper-adaptive quality automation solution will ensure compliance today and into the future as you can easily address new business and regulatory changes.

If you want to own your own quality and compliance experience, learn more about Intellect’s comprehensive, integrated and hyper-adaptive eQMS software suite and automation platform.


Tags: 483 Warning Letters, FDA regulations, FDA compliance, FDA, fda standards, Document Control, warning letter

3 Compliance Issues That Can Be Solved By Automation

Posted by Romeo Elias on Mon, Jul 16, 2018 @ 01:31 PM

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For compliance managers in any industry, it’s imperative to provide tools and practices for a company-wide commitment to quality. Whether the industry is construction, government, education, healthcare or manufacturing, there are usually plenty of different compliance regulations to meet.

In that kind of a corporate climate, being as efficient as possible at ensuring compliance can be a significant time-saver. Not only that, but efficiency at implementing some of the necessary compliance solutions can ensure that human error has been reduced to a minimum. And in today’s environment of technological advancement, efficiency is often the synonym for automation.

Automating compliance processes is something any company can benefit from, regardless of the industry. Still, automation is beneficial for those organizations that need to comply with ISO and FDA quality standards. Let’s have a look at three compliance issues that can be solved by automation:

Staying on Track with Quality Objectives

Automation of quality management doesn’t only mean that it will be easier to complete compliance and quality management processes in the technical sense. It also helps everyone in the organization be aware of the organization-wide quality objectives. Losing sight of them makes for inconsistent employee performance, and the organization might fail at building a culture around compliance and quality.

Since quality standards and goals are visible to everyone in an automated system, it makes it easier for the employees to meet them. And, in the case of collaboration with external teams, it ensures that the same quality standards will apply to them.

Corrective And Preventive Actions (CAPA)

CAPA is an integral part of any automated QMS, and it’s crucial to staying within compliance standards. In case of any undesirable events, the CAPA can help identify its cause. After that, it’s only a matter of prevention and coming up with a plan that won’t let it happen again. A procedure that helps set everything back on track is necessary. By having an automated solution that handles it, everyone in the organization will be aware of how best to handle any unwanted situation and resolve it quickly.

Document Control

An automated system creates a centralized hub for all organization-related activity. And when it comes to daily functions of an organization, document control is one of the most critical processes. Without a well-organized document control system, you’re inviting chaos into your organization (and most likely inspection as well.) Since FDA-regulated and ISO-certified companies are required to have a document control system, it’s clear to see how problems in this area can affect the whole company. Keeping up with audits and making sure that all necessary documents are created, stored and shared according to the company’s quality standards helps maintain a team that’s more accountable and informed. Therefore, automating document control can significantly improve an organization, not only with compliance but with the day-to-day operation as well.


Today’s business revolves around complex rules and regulations. To ignore any of them is a fatal mistake, but to comply most efficiently, you need a staunch ally. An automated compliance solution that can meet your company’s unique needs could be the difference between success and failure.

With Intellect’s QMS solution, you don’t have to develop your workflow unless you want to customize the existing ones. It works out of the box and makes sure you have an easy time automating your organization’s quality management and compliance processes.

Tags: automated solutions, business automation, workflow automation, iso compliance, laboratory compliance, FDA compliance, mobile compliance, Compliance, CAPA, Document Control

The Effects of Document Control on Certain Industries and Risk Management

Posted by Romeo Elias on Thu, Mar 15, 2018 @ 09:41 AM

 

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The purpose of document control is to enforce controlled processes and practices in industries such as pharmaceutical, nutrition, and medical where there is a need to create, review, modify, issue, distribute, and access documents. Document control ensures critical data is indexed and searchable. It helps reduce errors in documentation and allows automation of tasks.

Document control ensures that documentation is accessible at all official points within an organization and is trusted by its users to contain accurate, up-to-date information that’s reliable and formally approved.

Document control applies to any business as it ensures efficiency, reliability, traceability, performance, quality, and safety. It is also a requirement from the ISO 9001 international standard which improves your market entry chances and gains your business a decisive competitive advantage.

ISO 9001 sets the foundation for you to increase efficiency and improve your processes and structures while minimizing your liability risk as it establishes the standards for creating and maintaining a quality management system (QMS).

Requirements of ISO 9001

  • Maintain a set of procedures that cover all key processes in the business
  • Monitor processes to ensure that they are effective
  • Keep adequate records
  • Check product output for defects, and use appropriate corrective action when necessary
  • Regularly review individual processes and the quality system itself for effectiveness
  • Facilitate continual improvement according to ISO 9001 standards

The Pharmaceutical Industry

In the pharmaceutical industry, document control is closely intertwined with quality control. According to the Good Manufacturing Practice (cGMP) regulations that are applied in the pharmaceutical industry, the responsibilities and procedures applicable to the quality control unit be in writing. These written procedures must be followed, and any deviations from them must be justified and documented.

The Food Industry

At the core of food control activities is the establishment of standards for safety, quality, and labeling. The food industry has a broad view of food control that involves factors such as safety, nutrition, quality, and value.

In nutrition, controlled processes include maintaining nutrient levels in food ingredients and formulating nutritional profiles that contribute to consumer interest. Appropriate documentation of procedures must be established to ensure that their control systems are defined, recorded, and maintained to permit auditing and verification that the systems have been correctly applied.

The Medical Industry

In the medical industry, document control systems are also at the heart of an effective quality system as it allows organizations to centralize their documents which include everything from work instructions to policies and procedures. An automated document control system has been the key to avoid errors committed by manual and time-consuming processes.

Document Control and Risk Management

These automated document control tools impact risk management as it significantly improves project accountability. Routing for revision and approval is automated, and access to essential documents is centralized.

Having accurate records requires access controls and tracking. Access is limited to individuals with the relevant permissions thus eliminating versioning issues, delays, or lost items. Only a system that automatically creates and stores copies of all date and automatically collects acknowledgment receipts whenever people access specific documents can accomplish that.

 

Tags: quality, Risk Management, Document Control, Quality Management System, Quality Management Software

Benefits of an Automated Digitized Solution for Document Control to Help Meet ISO and FDA Regulations

Posted by Romeo Elias on Mon, Feb 12, 2018 @ 11:56 AM

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Why do people cringe at the very thought of compliance and change? Perhaps it’s because compliance means having to behave according to someone else’s command, and it’s our natural reflex to be resistant to being controlled, and skeptical of change.

But what if our reluctance to change was causing our organizations to lose massive amounts of money due to inadequacies caused by outdated processes?

The loss of revenue that occurs when document control systems are inefficient can be significant, and can cost manufacturers millions of dollars. These inefficiencies can be traced to the use of paper/hybrid-electronic systems which partially involve a manual approach or the combination of both digital and paper files. As with any manual approach, this was prone to error which resulted in delays.

And for this reason, FDA-regulated and ISO-certified companies mandated with a document change control system have shifted to automated digitized solutions which eliminate the laborious and time-consuming manual management of documents.

Here are the main benefits of an automated digitized solution for document control and how it helps ensure companies meet ISO and FDA regulations:

Easy Creation of Various Types of Documents

An automated digitized solution simplifies document creation. Different document types mean handling each document differently and may consist of separate approvers and workflows. An automated solution simplifies the creation and approval of documents, assigning the correct workflow based on each document's unique routing.

Faster Review and Approval

It’s up to the system to route documents to be reviewed by the relevant employees, ensuring final approval is received on all documents before they are used and distributed. Automated digitized solutions

have intelligent business rules that make room for deviations in the process when necessary.

Employee Training Integration

When the Training Management system is integrated with a document control system, companies can easily define which employee needs training on each document. The systems updates training records, allows self-training, and automatically updates employee status when training has been completed.

Promotes Collaboration Through Visible Reporting

When the reporting system is integrated with good document control, employees can quickly and effectively look at data to run the necessary reports. Visibility allows employees to look at data and keep business processes consistent and controlled.

Keep Data Secure Through Intuitive Filtering

A centralized system doesn’t mean that all users should be granted access. For security reasons, employees should only have the appropriate access to documents needed for them to approve, review, and make any necessary changes. A document control system allows you to filter and secure data thus limiting visibility data to only what is relevant to each user.

In conclusion, document control systems are put in place to ensure manufacturers are building products that are reliable and safe. ISO and FDA regulations are enforced to ensure that both process and documentation follow pre-approved methods.

For a company to thrive, it needs to recognize that compliance is a necessary tool that will give it a competitive edge. Achieving and maintaining compliance ultimately leads to efficiency and better output. Having an automated digitized solution helps you achieve all that by eliminating manual processes that are prone to error, giving your ability to filter access, automate redundant processes, and ensuring the correct routing and workflows.

Tags: Document Control, FDA, ISO, regulatory, Regulations, automated solutions, Business Automaton

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