Depending on the contract details, Qualio+ customers may have access to customized content created and maintained by Qualio. Additionally, Quality Specialists will assist with formatting, tailoring and migrating the content into your production environment.
This service offering may compliment your existing documentation if you have it, which will be migrated using the Migration Manager. In these situations, your Quality Specialist will work with you, the Onboarding Manager and the Qualio Formatting Team to migrate your existing content into your production environment.
Your Quality Specialist will discuss timeline expectations with you for migrating both Qualio+ content as well as your existing content. Generally speaking, migrations of this nature tend to be longer due to the number of existing documents to be migrated and the level of customization tailoring your Qualio+ content requires.
Migrating Qualio+ Content - Process
This process will begin when you complete the Qualio+ questionnaire before you meet with a dedicated Quality Specialist. They’ll need to determine what your company profile is (ex: hardware, Pharma, SaMD) so that they may prescribe the proper content. They will also learn about your regulatory goals and other requirements such as additional certifications you are hoping to achieve/maintain. This can result in additional content to support information security management (ISO 27001), medical laboratory compliance (ISO 15189), or testing and calibration laboratories (ISO 17025).
Next, your Quality Specialist will generate a migration index which lists out the prescribed documents to be created, customized, and migrated. You can expect it to contain about 30-40 SOPs, 5-10 WIs, ~40 templates and ~5 event workflows. You’ll review the index prior to your Quality Specialist taking any further action to confirm the correct documents are being created. And if you’d like to view the details of each document, instead of just the index, your Quality Specialist can grant you 2-week visitor access to an environment with un-customized versions of the documents.
At this point, customers new to quality can feel overwhelmed at how much needs to be created. But don’t forget, Qualio+ content comes with a dedicated, seasoned industry expert. They can help guide you through the document stack and each step of the migration process.
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Other things to keep in mind:
The index does not represent a final decision of all content to be created and migrated. It can change based on your organization’s needs.
If you have existing content, your Quality Specialist can review content and perform a gap assessment. This may also result in changes to the migration index.
The migration index is simply a collaboration resource. It displays your Quality Specialist’s recommendations, but if you have change requests for the template name, template or document content, etc.…speak up.
Next is the long pole in the tent, the document creation/migration step. Your Quality Specialist will work with other Qualio team members to build your content to match your profile. During this time, you may log into Qualio and see documents in the Document Workspace being created and modified. However, do not edit documents, or change document ownership as this may impact the formatting process and confuse the Formatting Team. Your Quality Specialist will change document ownership into your name when the formatting and final review of the document is complete.
Once the document ownership has been transferred to the customer, you may begin the review and approval process using Qualio workflows till the document becomes effective in your document library.
What content is available?
Click the button below to view a Sample Migration Index. If you are interested in learning more about Qualio+ content and services, contact your Customer Success Manager to discuss your business objectives, scope, and pricing.