In numerous companies - especially in regulated industries such as medtech, food, pharmaceuticals, laboratories and automotive - a wide variety of evidence is required due to regulatory requirements. From simple reading, inspection or test certificates to training certificates and complex hygiene and safety checks - the requirements are varied and demanding. It is important to maintain an overview of open and completed certificates at all times in order to be able to efficiently and reliably provide evidence of implementation to authorities, control bodies and regulators at any time.

The IMS solution “Verification provision” enables the systematic recording and documentation of any verification variants throughout the company. Thanks to the end-to-end digital processes, clarity is created as to who or what was trained, checked or tested in the company at what time and on what topic. The verification function is linked to an electronic workflow. The workflow steps can be configured as required and adapted to specific needs.

Core functions of the “Process execution verification” solution

• Complete traceability (who planned the verification / training)
• Person to be trained is selected via job, group or person
• Information about the open task is sent by e-mail and/or dashboard
• Up-to-date overview of open training courses at all times
• Proof is provided per document / process version (with time stamp per employee)
• At the touch of a button: personal overview of open training courses / completed certificates
• Simple recording and planning of follow-up training and inspections
• Set a deadline: Set a date by which the training must be completed
• Reminder function: if a certificate is not completed on time, the system sends a reminder. Further escalation level: inform responsible person / supervisor
• Can be combined with freely definable process execution and with 4- or 6-eye workflow for document / process control

Summarized procedure for the “Training” verification variant

The IMS solution “Verification provision” enables targeted training and verification management for work instructions and guidelines. When creating or adapting a work instruction or guideline, the persons to be trained can be recorded and the implementation planned. Once the document has been approved and subsequently published, the persons concerned are automatically informed and assigned a task. The person responsible for the training can also see at a glance who needs to be trained. Once the training has been successfully completed, all persons must electronically confirm the successful completion in the system and thus provide proof of training.

Provide confidential and fully traceable evidence with dual control workflow

If document control is completely digital, paperless and with an electronic signature, specific requirements apply for some industries. To comply with FDA 21 CFR Part 11 of the European Medicines Agency or ISO 13485, companies must be able to guarantee the authenticity of electronic documents. The regulations stipulate the confidentiality of electronic records and complete traceability. IMS PREMIUM implements the relevant requirements with the 4- or 6-eye workflow with additional authentication and integrated proof of training.

Once a document has been created, it is checked by one or more reviewers and then approved by the approver (in a 6-eyes workflow). The role-based workflow requires a second authentication from the reviewer and approver. Different methods can be used to verify the person. In addition, it must be determined whether the document is to be trained. If training is required, the persons to be trained must be selected.

The training can be carried out by trainers or by means of self-training. If the person concerned has to carry out the training on their own responsibility, the request for training is automatically sent with the information that proof of training must be provided after the training has been completed. This is done by each individual user by clicking on the “Provide proof” button in the corresponding training form.

Clear displays are available so that those responsible for training have an overview of the status of all necessary certificates at all times. Whether for existing or new employees, it is possible to see at a glance which person has already completed a certificate and when, or will have to do so in the future.

The solution is available in German

(other languages on request)

The IMS PREMIUM software solution can be described as a workflow-driven information platform. All solution-oriented function packages for document control, GRC, quality, process, organization, risk and process execution/measure management offer the possibility to manage all information available in the company in a rights-based, versioned and traceable manner. 

There are virtually no limits to the combination of solution packages and options. Thanks to the modular structure, it is possible to react to changing company requirements at any time without losing the overview of all management areas.

All IMS PREMIUM functions can be used with mobile devices of any screen size. Thanks to the web-based and browser-independent software, any device can be used regardless of manufacturer and operating system. Simply open the browser already installed and call up IMS PREMIUM. This is one of the major advantages over app solutions, which only offer a limited range of functions and require complicated installations and updates on every device.