Aligned Elements is a Medical Device application lifecycle management (ALM) solution enabling fast development and regulatory compliance through improved Design History File management.

July 15 2018

That medical device development entails a lot of documentation should not be a surprise to anyone. Hundreds of documents are created, reviewed, released, then modified, reviewed and released again. The majority of these documents needs to be signed, often by two persons or more. Collecting signatures, although it seems like a trivial task, becomes a significant nuisance when the number of documents and releases increase.

One of our customers insisted on having 3 people sign each test case before release. Their 18 000 test cases yielded a combined signature collection effort of 5 man-years (estimated 30 mins to collect a single signature, their estimation).

It is rare to find medical device manufacturers that enjoy writing medical device development documents, but it is even rarer to find those who gladly spend their days collecting signatures for the said documents.

The obvious question is hence: how can we spend less time on document signatures?

For many medical device manufacturers, the equally obvious answer seems to be electronic (or digital) signatures.

So why is it so hard to get a signature?

There are several potential reasons for this. Maybe the Signer is a very busy person and simply has no time for this task. Maybe the Signer is located somewhere else through work, travelling, vacation or other reasons. Or perhaps the previous Signer did not pass on the document to the next Signer in line. Or maybe a formal signature sequence (order) is forced by the document process in question, where a Signer that actually is available, is prevented to carry out the task since some Signer further up the signing sequence has not fulfilled hers. Or it might be that the document in question cannot be signed before some other related document has been released (i.e. signed).

Thus, there can be formal reasons but also trivial reasons why a signature does not get timely collected.

The most trivial is of course that it is just hard to physically get the document in front of the Signer (or the other way around) for some reason or another. Once you get that far, the literary "stroke of the pen" is usually a quick affair. This is the perceived major efficiency benefit of Electronic Signatures. You do not have to physically get the document in front of the Signer. The document does not need to get passed around. The Signer can pull it up (from an E-Signing System) whenever he wants, from wherever he is. This allows a quasi-parallel execution of signatures. Two people on different sides of the planet can sign the same document at the same time (almost)! Costs associated with printing, sending, scanning and storing the paper copy are eliminated. E-Signatures also entail increased measures of security, enhanced authenticity, resisting tampering and also provide accurate signature audit trails.

Before explaining how to introduce an E-Signing System, let me say a few words about Digital and Electronic Signatures.

Digital and Electronic Signatures

Even though the terms are often used interchangeably, there are some notable differences between the two concepts.

According to FDA, Electronic Signatures are "Compilation of data (user name / password, dongles, biometric)", which is unique for a person. This can be used to sign documents and is as legally binding as a “wet signature”. The signature and the association with the signed entity (document) is stored in a database of the Signature System. Furthermore, not all E-Signing Systems leave a visual mark on the signed document that indicates that it has actually been signed.

Digital Signatures on the other hand, require a Digital Certificate that ensures the identity of the signer. A part of that Digital Certificate gets embedded in the signed document during the signing process. As a result, the validity of the signature can be checked independently of the E-Signing System.

So, someone needs to guarantee the identity of the signer.

For Electronic Signatures, the organisation (the manufacturer) does this by using the validates E-Signing System.

For Digital Signatures, it is the issuer of the Digital Certificate that ensures the identity of the signer. Digitally signed documents often also contain a visible signature.

Obviously, there seem to be several advantages using Digital Signatures. The validity of the signed document can be inspected independently of the E-Signing System, which is an advantage if the E-Signing System goes down, is corrupted or the system vendor goes bankrupt.

Any drawbacks?

Yes, a few. Obtaining a Digital Certificate from a third-party vendor is expensive and requires an administrative effort. There is the obvious question of where and how to store these certificates as well as associate them with the user. They also have the nuisance to expire after a while and therefore need to get regularly renewed. People also have a tendency to marry and change their names etc. which also leads to renewals. Furthermore, it is not guaranteed that the validity shows up correctly in third party viewers (like Acrobat PDF Reader), for technical reasons having to do with root certificates.

An organisation can circumvent all this by issuing their own Digital Certificates. This is somewhat of an IT "adventure" but it can be done. Costs can then be lowered somewhat but there is still a significant administrative effort. Moreover, internally generated Digital Certificates can of course not be validated by third party viewers (like Acrobat PDF Reader).

So, there are pros and cons with both options.

However, they have several similarities and most important of all, both methods are recognized by the FDA.

Let's do E-SIgning!

Let's say we want to engage in eSigning (Electronic or Digital). What kind of effort can we expect to get this up and running?

Here is a short list of some of the steps:

  • Assess the E-Signing System for Part 11 / Annex 11 compliance
  • Qualify the E-Signing System Vendor as Supplier according to your QMS
  • Assign responsible roles and people for the E-Signing System
  • Install and configure the E-Signing System
  • Make or buy the Digital Certificates (if used)
  • Adapt your QMS to recognize E-Signatures and describe how they are intended to work
  • Prepare all the Document Templates to be used for eSigning (the system needs to know where in the document the signature shall be placed. Page nr, location on page, margins and spaces etc).
  • Validate the E-Signing System
  • Create E-Signature User Guidelines and train all users in how to use it
  • Notify the FDA (which is compulsory)

There is thus a non-neglectable initial effort to set up the E-Signing System, and also an effort to keep it maintained, both from a process as well as from an IT perspective.

There are also several other things to consider before you decide to go down the Electronic Signature path:

Document Life Cycle

All documents have a life cycle and the signing is only a very small part of this process. You need to consider how the document gets into the E-Signing System, how it interfaces with other systems such as Document Management Systems, workflow engines or e-Forms of which the document may be a part.

You also need to pay attention on how you plan to archive the electronic documents. This might seem like a trivial question but it is more depth here than you think.

External Users

If external users (as in external to your organisation) are going to use the system, you need to prepare a process where they get access to the E-Signing System, including setting up a corresponding user in the system with the appropriate Digital Certificate if applicable. These external users also need to get trained in how to use the system.

Hybrid Signature Situations

Are you going to end up with documents that are partly signed electronically and partly with traditional "wet signatures"? If so, you need a described process for this as well.

Ownership

Last but not least you need to establish who has the ownership of the E-Signing System. Is it the IT Department that usually acquire and maintain IT systems? Or is it the R&D department that probably is the most frequent user of the system? Or is it the HR department that is concerned with the identity of the people working in the organisation? This needs to be clarified before you start.

Predicted Outcome

As mentioned, an E-Signing System will decrease the effort of placing the document in front of the Signer. It will reduce costs associated with transporting the paper copy of the document. It will also potentially increase security and authenticity of the documents.

But there are things an E-Signing System cannot do. Regardless of how deep you entrench E-Signatures as a paradigm in your organisation, you will almost inevitable have a residual number of documents that are signed with ink. Thus, no matter how much you push E-Signatures you will end up with a hybrid system, composed by documents signed electronically and documents signed with ink. Be prepared for this.

Then, a Signature System is per se an IT system with all the work it entails. It needs to be validated and maintained, people will repeatedly forget their credentials if they do not use the system frequently and there will be the ubiquitous bugs and errors. This all means increased costs that need to be compared and contrasted with the costs by using a manual system.

Finally, an E-Signature System does not make bad processes good just by digitizing them. Overloaded employees will still remain overloaded regardless.

For which situations does E-Signatures make sense?

E-Signatures make sense when signing is a routine operation i.e. when a user makes several signings per week. E-signing for the occasional (or maybe even singular) CEO signature on a Product Requirements Document does not warrant the effort.  

Document types that are well suited for E-Signatures are those that exist in many instances and that are comparably small amount of actual content (as in quick to read). Examples of such document types are time reports, expense reports, purchasing approvals and test case documents.

Last but not least, maintenance is of course made easier if all Signers are part of the organisation (as opposed to involving multiple external users).

Efficient with and without E-signatures

If you find it cumbersome to collect signatures today, there are several ways you can scrutinize your organisation for efficiency improvements.

Analyse current signing process

Are all these signatures really necessary? Ask yourself why they were added ("It is required by our process" is not a valid answer) and most importantly, what does the particular signature mean? In what way does a particular signature make the document "better"?

Don’t get dependent on busy Signers

The overloaded Project Manager or CTO that never has time for signing is a common bottleneck in many organisations. Appoint deputies to all signing functions (the deputies shall also have deputies). Try to avoid sequentially forced signature sequences. They cost more than they bring. Finally, simply planning the signing occasion like a regular meeting (set up a meeting in the calendar) might yield you some good results.

I hope this post has highlighted some of the pros and cons of employing Electronic Signatures. If there is anything I want you to take home it is probably this:

  • Signature efficiency stands and falls with the process, not the system
  • Analyse and improve the process first!!
  • E-signatures can be very beneficial in specific situations
  • E-signatures gains (i.e. speed gains) must be weighed against costs

Aligned Elements supports electronic as well as digital signatures of documents with automatic relaying to external Document Management Systems.

If you would like to get a demonstration of e-Signatures in Aligned Elements, just let us know.

July 10 2018

What's New

Aligned Elements V2.4 SP 5 (2.4.213.14327) is a hotfix for solving an upgrade problem for projects from V2.4 SP 2 and earlier to the newest version of Aligned Elements.

Upgrade now

This is the recommended version.

Find the installer to Aligned Elements V2.4 SP 5 here.

July 03 2018

What's New

With a complete overhaul of the Aligned Elements Web Client frontend, we are pleased to give you a much better user experience. In this release we also introduce the Aligned Element dashboards, improvements to the Review Experience as well as several changes requested by our customers (to whom we always listen!)

 

Dashboards

Have you ever thought that although there is an immense amount of valuable information in Aligned Elements, getting the overview of the current state of affairs is not particularly straight forward. Enter Dashboards, you can now configure your own cockpit from a large number of Widget types. Web client information at your fingertips!

Dashboard

 

Web Client Frontend UX Enhancements

With a proper Sidebar navigation as well as side-by-side operations of Project/Trace Explorer and the Items, the need for jumping back and forth is significantly reduced. Event based updates removes the needs of manual refreshing. A useful Test Run Burndown chart is now tracks your progress.

Frontend

 

Enhance Design Review UX

The Design Reviews now display the Design Control Items just like they appear in your documents. You can create and assign issues directly to the Design Control Items without having to leave the context. We have also added an option for the Reviewer explicitly state completion of all assigned tasks with a single button click.

Review

 

What's Changed

  • New Inconsistency rules for Missing Test Executions in Test Runs and Unique attribute values
  • Improvements in management of External Issue Management systems
  • Clearing File attribute values
  • Warn on commit on selected inconsistencies
  • Improved performance for Cloud Projects

Upgrade now

With important fixes and a handful improvements, this release is a recommended upgrade.
Find the installer to Aligned Elements V2.4 SP 4 here.

April 01 2018

 

Sharpen your Skills 2018

May 17th, 2018 | HWZ University, 3 minutes from Zürich Main Station

Skills

Compliant and Efficient Medical Device Development

An impossible combination? 

Join us to gather concrete and practical advice on how to meet trending medical device development challenges in 2018.

We have called on a group of experienced industry expert to share their latest best practices on how to eliminate problems with you.

Register now to reserve your seat!

We look forward to see you at this event. If you have any questions or information requests, please don't hesitate to This email address is being protected from spambots. You need JavaScript enabled to view it.


Key Learning Objectives

Medical Device IT Security

Live hacking session, an introduction to the regulatory requirements and hands-on tips for developers of medical devices - by Prof. Dr. Christian Johner, CEO, Johner Institute

Implementing GDPR at Polar

Learn more about how Polar implemented one of the most important regulatory changes in 2018. If you haven't started yet, get the do's and don's from Niclas Granqvist, Director Apps & Electronics, Polar Electro Oy

Common Usability Engineering Pitfalls

What could possible go wrong? Expected and unexpected outcomes from the usability engineering process based on real life examples - by Andrea Schütz-Frikart, Human Factor Speciailist, Frikart Engineering GmbH

Post-market surveillance, Transition from MDD to MDR

The lean and mean approach to performing MDR post-market surveillance using a realistic framework - by Stephanie Grassmann, MedTechXperts GmbH

Modular Design Control Documentation

Can Design Control Documentation be modularized and re-used in several Medical Devices? Discover the Pros and Cons - by Karl Larsson, Design Control Documentation Expert, Aligned AG

 


Time and Place

  • Date: Thursday May 17th
  • Time: 08:15 - 13:00
  • Place: HWZ University, Zürich

Presentations are held in German. Slides written in English.

Target audience

This event is aimed at medical device development professionals, project managers, QARA professionals, R&D personnel and other industry professionals engaged in medical device development.

Registration

We are looking forward to see you at this seminar!

Registration Fee: 125 CHF

30% early bird discount for registration before May 1st.

 

 


Location

Address: HWZ Hochschule für Wirtschaft Zürich, Lagerstrasse 5, Zürich

 

HWSMap

 


About Aligned AG

Aligned AG provides Aligned Elements, a Medical Device ALM system that accelerates and ensures compliant Design Control documentation for medical devices. We assist our clients in developing regulatory compliant products within shorter time-frames, to lower costs and with higher confidence. 

February 24 2018

Test managers often have to deal with superhuman juggling of timelines, resource allocations and continuously changing specification while facing increasing pressure from management as the shipping-date draws closer. Furthermore, the test manager is responsible for making sure that the traceability is completed, that test data integrity remains intact and that change management procedures are followed correctly, even under situations of extreme stress.

Efficient change management, planning, tracking and reuse of test executions are therefore much appreciated tools in the V&V Managers tool box. The Aligned Elements Test Runs aims to address these challenges. The Test Runs manages the planning, allocation, execution and tracking of test activities. Let's dive into the details.

Planning the Test Run

The Test Run Planning section is the place to define the Test Run context, much as you would write a Verification Plan.

The Test Run Planning information includes:

  • What to test i.e. information the Object Under Test and the addressed configurations
  • When to perform the tests i.e. the planned start and end date for the Test Run
  • Who participates in the test effort i.e. the team of testers and their allocated work
  • How to test the device i.e. which test strategy to use by selecting among the existing test types
  • Why the test is being done i.e. the purpose or reason for performing this particular set of tests on this Object Under Test

Quality Assurance in Aligned Elements

Allocate existing Test Cases from your Test Case library to the Test Run by using simple drag-and-drop. You can use any number of tests of any available types from any number of projects. If needed, add Test Run specific information to the Test Cases and designate the Test Cases to the members of the Test Team.

Once the planning phase is completed, the Test Execution can begin.

The Test Execution phase 

Test Case data is kept separate from the Test Execution result data, permitting a high degree of test case reuse and a clear separation between Test Instructions and Test Results.
Consistency checks are optionally carried out on the Test Case before execution in order to ensure that tests cannot be performed until all foreseen process steps are completed.
During execution, the test input data is optionally kept read-only, preventing testers to modify a reviewed and released Test Case during execution.

All Test Team Members can access the Test Run and simultaneously Execute Tests as well as continuously monitor how the Execution phase progresses.

Test Run Progress Bar

Real-Time Test Execution data is presented through:

  • Individual Test Execution results including any found defects as well as colour coded feedback on states
  • Colour coded test progression statistics, with possibility to drill down on e.g. individual Testers or Test Types
  • Burn down charts, showing how planned Test progress over time corresponds to the actual progression

Defect Tracking

During Test Execution, Defects and Anomalies can be created and traced on-the-fly without having to leave the Test Execution context. The Defects can be tracked in either Aligned Elements internal Issue Management system or already existing integrated Issue Trackers such as Jira, TFS, GitHub, Trac or Countersoft Gemini or any mix of these systems. Created Defects and their corresponding status are displayed in the Test Run.

TestCaseList

Test Case Change Management

When developing medical devices, it is of paramount importance to keep your Design Control under tight change control.
The Test Run assist the testers and test managers in several ways to accomplish this goal, including optional actions:

  • Preventing inconsistent tests from being executed
  • Preventing input data to get modified during test execution
  • Allowing Test Managers to lock/freeze Design Input and Tests during execution
  • Alert testers when attempting to modify tests for which valid results already exist
  • Signalize weather a Test Case has been reviewed and released or not
  • Allowing the user to explicitly invalidate existing test results when a test is updated with major changes

Testing Variants of the Object Under Test

If several variants of the Object Under Test exist, it is sometimes desirable to create variant specific test results for common test cases and subsequently create separate traceabilities for the variants. The Test Run uses a concept called "Configurations" to achieve this behaviour. A Test Case is executed for one or more Configurations to make sure that variant specific test results are kept separate.

The exact data composition of a Configuration is customizable to fit the needs of each customer.

Complete the Test Run

Once all Test Cases has been completed, the Test Run and all its content is set to read-only. Optionally, a Snapshot of all Test Run relevant items is created as part of the completion procedure. A Test Run report containing all the necessary Test Run information can be inserted into any Word Document using Aligned Elements Word Integration with a single drag and drop action.

The Test Run is a Test Managers best friend, providing the flexibility needed during test planning and full transparency during test execution, making it possible to quickly react as real time test events unfold.

Note: Burn Down Charts is under development at the point of writing and planned to be released in the next service pack.

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