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