Preparing for an eQMS

Tips for a successful digital transformation

Written by Lydia Olu-Harding
Updated over a week ago

Whether you are new to Qualio and getting started with your onboarding project or you’re ready to implement new Qualio features like Design Controls or Quality Events, we’ve got some suggestions to help you prepare for and successfully complete your project.

Our Customer Success team discussed this topic in a recent customer webinar and revealed some insightful suggestions based on their years of collective experience. View the recorded webinar below then browse the additional content and helpful resources provided in this article. Questions posted by customers during the webinar have been recorded at the bottom of this article.

(Recorded 8/31/2022. Runtime 46:28)

5 Factors of Successful Qualio Implementations

You’ve heard the sage advice to learn from other’s mistakes, but you haven’t had a front row seat to the hundreds of Qualio Implementation projects like our Customer Onboarding Team has. Therefore, we collected and analyzed some positive and negative behaviors and wanted to share these Lessons Learned with future new customers in order to avoid unnecessary mistakes.

Those who fail to learn from history are condemned to repeat it.

- Winston Churchill

Qualio Champions make or break the project.

It’s 2022 and the life science industry will only continue to have more digital transformation, not less. Champions of digital growth have proven themselves to be essential to the organizations they work for and the vendors they partner with. Qualio embraces these digital champions with open arms (digitally of course).

Ideally, Qualio Champions are Quality Managers or Directors with acute awareness of four things: 1) their business’ objectives, 2) quality industry best practices and regulations, 3) the Qualio platform, and 4) how to communicate the other three things to both upper leadership and rank-and-file employees.

A Qualio Champion can present themselves even before an onboarding project gets started by communicating with their Account Executive and Project Manager to set expectations. When we know what you want to accomplish we will do every reasonable thing we can to help you get it. Then, as the project progresses, that communication has to stay open with the whole project team. Be real (and sometimes vulnerable) about roadblocks, risks, and resources.

Too much, too fast.

We get it – you are excited to begin your eQMS journey with lots of ideas and energy to put into the project. Excellent! That’s how we like to start projects too. But we also want to make sure the excitement and energy last throughout the entire project. So your Onboarding Manager is going to be very truthful with you about over ambitious migration timelines and expectations.

In 2022 our Onboarding Team began testing “mini-migrations” with marked success. Now we recommend it for every new customer. During your mini-migration you’ll focus exclusively on migrating your most essential Policy documents. This will allow you to interact with and learn the system and features without being overwhelmed by the volume of documents to be migrated. Once the most essential documents have been reviewed, approved, trained on, and made effective, THEN you can migrate another batch of documents.

Your Onboarding Manager will work with you to help you determine what your migration priorities are when it comes to moving the rest of your documents into Qualio. Think about document hierarchy and what documents will point to other policy, procedure, and work instruction documents. Then confirm the migration plan with your Onboarding Manager and if they blow their lifeguard whistle, just remember, it's for your own safety..

Project Management tools exist for a reason.

All customer onboarding projects are managed using and shared with you, the customer. It’s really easy to use and has instant visibility of the whole project or small task details; whatever you need in that moment.

Project management tools allow project teams to work asynchronously; it removes the need to meet constantly just to stay abreast of who is doing what. And there’s no limit to the number of people we can add to the project (although best practice dictates that we should keep it to a handful.) Set the expectation now for all team members to update their own tasks instead of funneling information to one person. That just creates an administrative headache, nor is it necessary with…you guessed it, project management software.

Customer Account Team - Who’s invited?

If you were going to host a backyard BBQ, you’d surely invite your neighbor that makes an amazing banana cream pie, and friend that always sends you the best music playlists. And although a Qualio Onboarding project isn’t exactly a party, you still want to make sure the right collection of people are included.

Here are a few key players that often get overlooked, or brought in too late.

  • IT / Security Team - Especially if you’re considering any integrations.

  • Learning & Development / Enablement Team - They can help with new hire training and/or provide a Trainer.

  • Product Development Leadership -

If well managed, initial conversations with these individuals can be an introduction to Qualio and explanation of what you hope to accomplish with an eQMS. Use our Interactive Product Tour to give them a visual experience. Then, when you need to have later conversations with these key individuals, they won’t feel left out or caught off guard.

Master your New eQMS

Customers who master the functionality of Qualio early on are better prepared to assess options during implementation and make decisions for future focused solutions. Accounts with 1-2 resident Qualio experts have an enormous advantage to gaining the most out of their eQMS. Here are some tips to get started:

  1. Use and abuse your sandbox. Learn how to use Qualio functionality by exploring options in your sandbox.

  2. Read Help Center articles and watch training videos for clear explanations of how the features should work. Attend our customer webinars and explore posted best practices.

  3. Log unanswered questions for follow-up during your next Onboarding session. Your Customer Onboarding Managers are there to help you understand the functionality and solution around tricky use cases. But it does help if customers have a basic understanding of the feature.

Questions and Answers from the Webinar

Onboarding Timelines & Best Practices

  • When can a customer start using Qualio? Can we begin before all documents have been made effective?

    • Typically customers will want most/all of their documents migrated into Qualio as part of the initial onboarding. Once that is complete, you will review, approve, and make these documents effective. Some customers may begin inviting users before all documents are effective, but it is most common to have most/all documents effective before inviting the rest of the users.

  • Our onboarding project has been slow. How can we go faster?

    • To ensure that the project progresses as smoothly as possible, it’s important to follow tips that were demonstrated in this webinar - make sure you’ve got dedicated resources (but not too many!), a good handle on your documentation and how you’d like to tackle bringing it in, and remaining in regular communication with your Customer Onboarding Manager (COM) to discuss templates, tags, and all other necessary pieces of information to get your eQMS ready to go. Oftentimes our delays are a result of a large number of documents to migrate, a lack of dedicated resources, audits, or a combination of all three and more!

    • Another idea - discuss with your Onboarding Manager the use of to manage your project and keep the teams aligned and focused.

  • My Onboarding project was completed in March, but we still have not gone live internally. We need some additional hand holding to launch Qualio and also intend to use Design Controls. Is the COM still available to me?

    • Since the onboarding project has been completed, you will now be reaching out to your CSM who will work with you to discuss what’s needed for your internal go-live. Your CSM will also get you in touch with our team that will assist you with Design Control implementation once you’re ready to go!

  • What are the advantages of Qualio Plus services when onboarding?

    • Customers with a Qualio Plus subscription gain access to a Quality Specialist who advises industry best practices, audit preparedness and regulatory compliance. They also have access to our content library! Learn more about Qualio Plus here.

Sandboxes & Production Accounts

  • Where can we find the sandbox?

    • Casey demonstrated where to find and access your sandbox. Advance to 33:20.

    • Learn more from this article: Switching between Qualio Accounts

    • Next to your name on the top navigation bar you’ll see your company name. Click on your company name, and you should see a sandbox instance in the dropdown menu. If you do not see this option, first consult with your Qualio Admin/Quality team to confirm a sandbox exists and to be invited. If one does not exist, reach out to our Support Team via in-app chat and we’ll work on getting you a sandbox.

  • Is sandbox configuration and documents transferable to live Qualio Production account, or will it need to be configured manually in the Production environment?

    • Nothing is transferable from the sandbox to production. All configurations, templates, documents, etc. will need to be manually re-created in the Production account. The system prevents any sort of data transfer from one instance to another.

  • Can all of the functionality of Qualio, "Docs, DEVS, CCs, Supplier Management, Equipment Management, etc" be practiced in the sandbox? I would like to do some practicing while the validation process is being completed.

    • Yes. Sandbox and production accounts have the same functionality/codebase. The only exception will be in the billing area

Document Editor / New Editor

  • When are you going to improve your document text editor? We are editing docs in Google Drive/Doc then reviewing in Qualio.

    • Great question! We actually re-released the beta this morning for customers who were part of the beta testing team. We will begin rolling the new editor out to new customers in September, and then migrating existing customers in Q4.

  • Creating form templates with many columns (ex. DHR, Bill of materials) is difficult without landscape formatting. Will Landscape page view be available with the new editor?

    • Landscape view will not be released in the first version of the new document editor. However, our Product Team is investigating the feature and it may be available in future versions of the editor.

  • Are there any intentions of bringing review cycle annotations (replace, crossout, etc.) to Qualio?

    • The first version of the new editor will include edit suggestions as well as inline commenting making document review more collaborative.

Migration and Validation

  • If my Onboarding project is completed, but I’ve identified additional documents to migrate, can I migrate those on my own?

    • If there are only a few more documents to migrate, this can be done manually by you by following the normal document creation process and copying the information in. If there are a significant number that would need to be migrated via the Migrations Manager, please message your CSM and they will reach out to the onboarding team to determine scope and any associated fees.

  • When is revalidation required?

    • With each change that is released in Qualio, there is an included risk assessment listed in the Product Changes page. Ultimately, revalidation is a judgment call of the customer based on internal risk processes, or if there is a procedure to validate periodically. For any changes that the Qualio Quality team has deemed as a significant change to the system, we provide at least 30 days for customers to use the new features in the sandbox and complete validation.

  • What is the easiest way to migrate a template from the sandbox to the production environment?

    • If you’re currently in the onboarding process, you can request help from your Customer Onboarding Manager (COM) for any templates you’ve built in your sandbox that you would like moved into your production environment. If you’d like to move a template over on your own, it would need to be done via creating sections/steps (if an event) and copying the content from the sandbox template into the production template.

  • I validated my version of Qualio Nov. 2021. Am I behind in doing another validation?

    • This would depend on your internal risk assessment of the product changes that have been released since then (which can be found in the Product Changes page under the gear icon of your account). If you’d like to re-validate or request our executed documentation, you can reach out to our support team (either via the in-app chat or or your CSM at any time so you can ensure you have the most up-to-date documentation.

Qualio Functionality: Tags, Training, Events & Suppliers

  • How can Tags be used to optimize documents gathering and migration when onboarding Qualio?

    • Tags offer a chance for organizations to simplify their document template strategy. Rather than utilize different templates to designate different departments, products, locations, etc. Let tags do the work! Stick with basic document templates like Policy, Procedure, Work Instruction. Then use the tags to categorize and filter your documents.

  • Would you recommend creating Qualio User Training Checklists for the different types of users? For example, I am planning on creating assignments in the Sandbox where Normal users need to demonstrate proficiency on the different Event types and other features such as adding a new Supplier. I would give users access only after they demonstrate proficiency.

    • This is a great idea to ensure adequate training get’s performed for all of your users. We have also seen customers create a “Qualio Training” document template with a unique training document for each user level that covers all things Qualio at their specific organization. This allows you to capture training on Qualio, right in Qualio.

  • How do you define an “event”? Like a “multi-step process?

    • Yes. Quality Events are predefined, repeatable workflows requiring response and tracking in accordance with regulatory requirements. They can be as simple as one step to log an event, or complex with multiple levels of content, action, and validation. Learn more about Events here.

  • Is there a way to preview an Event template I created?

    • Your sandbox would be a great place to preview event templates with fake event data.

  • Can events be updated as the customer continues using the app?

    • Yes, event templates can be modified at any time. New event templates can also be created at any time. Learn more about Event Templates here.

  • Any chance a Bill of Materials management tool will be created for Supplier section? Having a controlled way to release each part to manufacturer release or if part changes due to world wide shortages.

    • We are considering integrations with procurement systems to facilitate this functionality. Using the in-app chat, please let us know if you would be interested in participating in discovery once we begin work on this.

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