“If it wasn’t documented, it didn’t happen”: The life sciences sector can be a real stickler when it comes to requirements for creating, testing, approving, maintaining and distributing documentation. And when changing over to electronic documentation processes, numerous complex guidelines must be observed, which is why many mid-sized life sciences businesses still rely on paper-based workflows. However, this reluctance carries a hefty price tag in light of the vast manual effort and human errors involved.
Accurate documents for your corporate processes
The d.velop ECM system specifically designed for the life sciences industry is an end-to-end solution that provides all standard ECM functions while also meeting all typical requirements for document-driven processes. These include: document guidance, training management, deviation control with corrective and preventive action (CAPA), change control, audit management, electronic batch documentation, contract management and a digital personnel record.
On top of this, d.velop empowers you to optimize your administrative processes based on electronic workflows: The standard solution for e-mail management, incoming invoice processing and integration into popular ERP systems from SAP, Microsoft or Infor turn your solution into a full-fledged archiving, DMS and workflow system.
Best-fit components for reliable digital workflows
The contract management module implements a multi-level procedure to keep you informed about key dates such as termination windows or extension options, enables employees to digitally access all contracts relevant to their work, helps you stay on top of all contractual payment obligations, and facilitates the creation of new contracts on the basis of approved text modules.
The digital personnel file introduces a clever authorization scheme for managing application documents such as credentials etc., requests for leave, certificates and so on in digital format, thus doing away with unwieldy paper-based workflows. And in areas where paper documents cannot be avoided – such as incoming mail – d.velop helps you to efficiently process all relevant information.
Be it standard operating procedures (SOP), process descriptions, test regulations, operating instructions, contracts or any other document type: The ‘Document Control’ (Dokumentenlenkung) module designed by d.velop specifically for the life sciences industry introduces electronic processes for making revisions and signing documents. ‘Employee Qualification Management’ (Mitarbeiter-Qualifizierungsmanagement) expands the ‘Document Control’ module by adding active planning and logging of your employees’ qualifications.
Last but not least, d.velop provides you with the right tools to digitally map paper-based processes relevant for production – such as deviation reports, corrective and preventive actions or change management – thus allowing you to enter all data directly at the computer. As part of this process, the electronic form is automatically forwarded to the next stage/processor. Whenever the predefined processing time is exceeded, you will receive a corresponding escalation alert – either within the system, as an e-mail, or both. Lastly, task routing calls for substitution rules, which the d.velop system also takes care of as a matter of course.