4 Steps to Achieve Workflow Compliance

Posted by Romeo Elias on Thu, Apr 19, 2018 @ 11:29 AM

 

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All companies, regardless of industry, are responsible for ensuring that their policies and processes are designed to comply with applicable laws and regulations. Because of the complexities of regulations and requirements, many companies struggle to secure compliance.

Companies who compliment their efforts with technology have found that staying compliant has become far less challenging. In the past, businesses had no choice but to rely on Excel sheets and Word docs to keep track of all their people and processes. It meant exchanging numerous emails and risking communications getting lost. Innovative software means the end to duplicate reporting and copying data repeatedly.

These centralized technology tools meant having confidence in your compliance and meeting regulatory requirements. Compliance workflow automation gives you the ability to audit multiple tasks into one process and schedule these processes to run on a regular basis automatically.

While the technology has been revolutionary, it still doesn’t relieve compliance teams of monitoring people, processes, and anyone else who must meet compliance obligations.

One of the crucial steps to ensuring compliance is streamlining workflows to ensure that only employees who should have access to specific data have relevant access. The purpose of a workflow is to divide processes into smaller steps which are passed to different people with the company.

Because of the multiple exchange of hands in documents, there could be numerous submissions for review and need for amendments. All the necessary steps should be taken into account and control processes must be enforced, and verification of information should be ensured.

Here are some tips track and monitor workflows to ensure that they achieve compliance, and nothing is overlooked or goes missing:

1. Identify Legal Obligations

What are all the compliance obligations and how do they impact your business? Once you have identified what these are, interpret them into specific compliance requirement statements.

Each of these requirements should be organized according to underlying regulations and codes along with common requirements such as policy development and monitoring requirements.

2. List All Parties Subject to Audits

List everyone who will be held responsible for meeting compliance obligations; this includes people, vendors, 3rd parties, sites, and processes. Because this will likely be a comprehensive list, be sure to organize them in department folders.

3. Evaluate Level of Risk

It’s impossible to monitor every aspect of your business at all times; instead of attempting to do so, focus your attention on where risk is highest. Identify who you would consider as compliance risks to your business based on criteria that evaluate the levels of risk.

4. Determine of Level of Attention

Set up your system to conduct audits regularly. Audit frequency should be established based on the level of risk. For obvious reasons, high-risk people, processes, and parties should be audited more frequently than those that are considered as low-level risks.

While the right software can help you achieve workflow compliance, the reality is that your employees are the risk that you will have the least control over. To become fully compliant, it’s important to not only streamline your processes and systems but also regularly review your people.

 

 

Tags: Workflow, Workflow and Business Process Management, Compliance, Workflow Managment, workflow automation, Audits, Risk Management, quality data, digital transformation, legal, risks

Preparing Your Business For Digital Transformation And Compliance

Posted by Romeo Elias on Thu, Apr 12, 2018 @ 11:53 AM

 

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For businesses to keep up with the competition and respond to the change in consumer demand, they need to let go of outdated interfaces and practices. But before a company can make the digital transformation, it needs to decide how ready they are.

Beyond adapting to new IT systems and equipment, business culture will also be transformed. Not only will leadership need to establish a digital transformation strategy in relation to systems, process, and technology, but it needs to manage any resistance from employees who may worry about being replaced by new technology.

As you prepare for your digital transformation, alleviate the fears of your employees by empowering them with knowledge through updates and training. Your compliance team should also be involved in the early stages of your digital transformation to ensure alignment and keep all departments on the same digital page with regards to conducting business in full compliance with all laws and regulations.

In preparation for the transition, establish where your company is currently and what your goals are. You also have to determine if your organization has the resources and expertise to get you there. There are three main categories that your company is probably currently in:

Legacy system -  A legacy system refers to old method technology or an outdated computer system. These systems do not integrate with IoT. And without the ability to connect via IoT, a company with a legacy system will be out of sync with real-time operations. These systems will not be fit to meet the demands of today’s digital environment.

Web-enabled – While not ideal for digital transformations that are data-intensive, web-enabled platforms provide some data interaction. They also have a more user-friendly interface.

Digital ready – Your digital transformation will be hindered if your company doesn’t have a digital-ready culture. Digital-ready cultures are those that are highly innovative and whose decision-making is data-driven. If digital ideas and solution are your default option, then your organization has a digital-first mindset and are, therefore, digital ready.

In preparation for a digital transformation, your company must have a digital-ready culture and systems. One of the crucial first steps towards your digital transformation is deciding the right type of cloud that meets your company’s specific needs. Choosing between public, private, or hybrid will depend on your budget, scalability, and how much control you want to maintain.

You will also have some decisions to make on services within the cloud itself such as Software as a service (SaaS), Platform as a Service (PaaS) and Infrastructure as a Service (IaaS). Each comes with their own pros and cons.

The next step is data migration. It’s a chance for you to eliminate the unnecessary data that will only clutter your new systems, slowing down the migration process. Think of data migration as an opportunity to start fresh with only the relevant data you need. Remember that as you migrate to a completely new system, you need to rethink best practices. What worked in the past won’t be as effective.

Remember that adapting to your new system will not happen overnight and means developing a plan that will keep your business running as changes take place. As your company embraces digital transformation, leadership must champion the change to help align employees.

 

Tags: Compliance, digital business, business automation, quality, digital transformation

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

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

How Intellect Benefited One of The Largest Food Safety and Quality Companies!

Posted by Romeo Elias on Fri, Feb 23, 2018 @ 01:30 PM

 

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We had the pleasure to work with one of the largest food safety and quality services providers in the world. The company is known for working with clients as a trusted partner to promote public health through analysis, consulting, auditing, training, contract research, and sensory analysis services, through a network of global laboratories.

The Challenge

The multilingual global company needed a way to address and improve non-conformance response, customer complaint response, and compliance which included approvals, and documentation with Oracle CRM. The solution has to be multilingual to accommodate all their labs worldwide.

The company needed an effective solution to capture, track and maintain accurate, auditable non-conformance records through a centralized database. They wanted to streamline the process for identifying, evaluating, reviewing, and handling nonconforming parts, materials, and products and view any aspect of their workflow for complete transparency and reporting.

They also wanted to streamline customer complaints management to improve product quality and safety, decreases audit time, lower risk, and ensure FDA and ISO compliance.

The Solution

To address non-conformance, the company used Intellect’s NCM solution to create, track, and maintain accurate, auditable conformance records to ensure compliance with all management records. The “Quality Tools” app for non-conformance, customer complaints and corrective and preventive actions (CAPA) was configured to meet their exact business processes in 3 months. Employees are now assigned and notified of follow-up tasks to ensure accountability, automated email notifications and reminders.

In addition, Intellect managed their customer complaints by tracking the intake of customer complaints through investigations and CAPAs which enables continued improvement. The easy-to-use solution works on any device. Record incidents were centralized to facilitate investigations, report results better, and close cases. With Intellect’s Complaints Management, they improved communications with customers by acknowledging, tracking, and implementing any requirements that resulted in improved product quality and reduction in product recalls, ensuring compliance.

The solution met their multilingual requirements and was available to users in 8 languages, English, French, Spanish, Italian, Polish, Portuguese, Turkish and Mandarin.

 

The Results

The results were improved visibility to common issues for better resolution. Response time to customers on issues was improved. Internal audit tracking was overhauled resulting in reduced audits by 25%. ROI was achieved in less than 6 months. Overall, shared knowledge across the company was increased which ultimately provided considerable annual savings.

Tags: Workflow Managment, workflow automation, Quality Management Software, FDA

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

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

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

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

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