People often see importing as a relatively simple task. Almost as a simple copy-paste exercise.
The reality is actually quite different. Document import requires a lot of tasks and efforts, before the actual migration can take place:
- Selection and sorting
- Indexing and classification
- Overview and planning for versions, permissions and formats
- Business continuity planning
To ensure compliance and traceability, it is important to perform quality checks and testing. Both during and after the import.
When documents are received in bulks at intervals (from a CRO, sub-contractor, etc.) it makes sense to set up an automated import process. Depending on the consistency of the data quality, algorithms and processes can be automated and reused, significantly reducing the time and effort needed for subsequent imports.
Additionally, an automated setup also reduces the likelihood of human error and the workload on the line of business.
Quality & Control
Regulated industries like Life Science, Finance, etc. are required to be in continuous control of their documents. A controlled automated import can ensure an unbroken audit trail and traceability from the documents leave the external party, till it is safely indexed in the document management system. If required, the right import tool can also track any modifications or transformations done to the document metadata and structure.
HOW CAN STRATOR HELP?
Strator can provide resources, experience, tools, and compliance for an effective and controlled import.
Your import will build on the experiences of many previous projects and steer clear of the worst pitfalls. Our experienced consultants can plan, scope, and configure your imports, to get the right balance of quality, compliance and performance.
Specifically for GxP, we have know-how, templates and examples that we can adjust to fit your particular quality management system (QMS).