Your business is growing - that’s great! But now you may be wondering how your eQMS will grow with the changes. Whether the organization is opening a new laboratory, acquiring another business or product, or branching into different divisions, we have some ideas to help you manage changes to your eQMS.
Before we get started, it’s important to understand that Qualio has no ability to “push” document templates, documents, or any other record from one “instance” of Qualio to another.
Quick Navigation:
Things to consider regarding the expansion
Depending on the type of expansion, here are some things you should consider:
Corporate Hierarchy: Will a “parent” company have subsidiaries with unique instances or will all users, documents and events, etc. exist within one Qualio instance?
Documentation Needs and Overlap: Does the new site have its own documentation, and will it clash with existing documentation, or is it starting from scratch? If you decide to use multiple instances, how much overlap will exist between the instances that will cause a duplication headache down the road when documents need to be updated?
Document Segmentation / Visibility: If the organization branches into different divisions, will the same documents be used for each? Will one division’s document visibility need to be restricted from another?
Document and Event Templates: Because templates cannot be hidden, can a case be made for separate instances because sites/divisions have unique template needs?
User Strategy: Will users need access to multiple products or divisions? And if using multiple instances, will this cause friction with users because they have to log into multiple accounts to complete training, review documents, etc.?
Supplier Management: Will Suppliers be managed in the central “Parent” account, or will each division manage their own unique supplier records?
These questions are an excellent place to start when determining the best route for your upcoming expansion. Based on these answers, you can determine which route in Qualio would suit your needs.
New Site with No Documentation
If the new site is being built from the ground up, or a site with no documentation (or none that is being kept) has been acquired, there’s no need to worry about how you will consolidate any documentation. However, there are still questions to consider for this scenario. Below are a few to get you started:
Will existing documentation also apply to the new site as-is?
Will there be extra documentation that needs to be created for the new site?
If extra documentation is created, does the visibility need to be restricted?
Depending on the needs of the new site, you’ll need to decide if all documentation can be housed in a single instance or if you’ll need two fully-separate instances of Qualio. If documentation is kept within one instance, visibility can still be restricted for particular documents by using groups and tags to make sure that users are only accessing what they need. Even if no visibility restrictions are needed, tags can still be helpful to keep documents organized and easy to filter. Having groups for your users will also allow you to easily set up Training Plans by site as you invite your new users into your instance.
If you determine that separation is the better option and multiple instances will be leveraged to segment users, documents, events, suppliers, etc., consider which users will need to be invited to all instances, like members of the Quality Team. They will need to switch between accounts to complete their eQMS tasks, just like you would switch between a production account and a sandbox.
Acquisition with Existing Documentation
If the acquired company has existing documentation, it’s highly recommended that a full review of those documents be completed before implementing Qualio. Look for duplicate procedures like Change Control, Risk Management, etc., and determine which procedure(s) to use going forward or what needs to be updated.
With a review done upfront, the migration of documents into Qualio will go much more smoothly and will result in fewer extra documents/versions created if they don’t need to be uploaded initially.
Will the acquired company be able to transition to all existing policies and procedures already approved in Qualio?
Will any existing Qualio documents need to be updated to include this new site? This could include anything from adding the site name or location, consolidating equipment documentation, or retiring documentation that’s no longer applicable with the addition of the new site.
Will documents need to have restricted visibility depending on the site? It’s possible that all documentation from the acquired site could be migrated into Qualio and can be tagged to indicate the relevant site. Learn more about tagging here.
Are you going to group employees by site(s) that they work at? Some employees may need a different training plan than others, depending on their responsibilities at the site they’re located.
Adding new products, but everything else stays the same?
If you are simply adding new products/divisions that require no change to your existing documentation, Qualio’s Design Controls can accommodate the management and design requirements and testing of multiple products.
From the Design Controls dashboard, click “Create Product” to begin.
Pros and Cons of a Single Instance vs. Multiple Instances
Generally speaking, there is more work up front to set up multiple instances, but the benefit may be balanced overtime with the long term management depending on the number of users, documents, events, etc in each instance. Both options come with pros and cons that should be considered.
A Single Instance
Pros:
All data is accessible to all users regardless of site (with exception to restricted tags) and easily searchable in the Library
Least potential for duplicate documents to be created per site for a more homogenized system
Ease of training management for the entire organization via Training Plans
Only one account for the Admin(s) to manage when new users join the organization
Cons:
If there are a significant number of sites, group management and restrictions could become challenging to manage
If separate sites have significantly different workflows and require their own templates, a more extensive list of template options could potentially lead to more human error issues for document and event creation
Multiple Instances
Pros:
Each site could have its own dedicated templates without the risk of accidentally selecting another site’s template
With fewer users in the instance, user management could be less burdensome to the Admin
Could reduce the need for restricted tagging of documents
Easier management of more niche groups that may be at one site but not another (fewer overall groups)
Cons:
If you have users that need to belong to multiple sites, ensuring any training that needs to be completed in each instance could become challenging to manage
Any organization-wide procedures would need to be duplicated in each instance
Any groups, training plans, and tags would need to be created in each instance
More administrative work if one or few users are responsible for maintaining all instances
Additional cost for each Qualio instance
Next Steps
For any of the above scenarios, contact your Customer Success Manager (CSM) for more information. If you are unsure who your CSM is, please contact Support through our in-app chat or via support@qualio.com