STORY HIGHLIGHTS
- The platform must be audited regularly and obtain a SOC2 certification, proving that both organization and system meet the highest standards in terms of information system quality and security.
- Provide information in short and clear steps an operator can easily read while doing the job. For some tasks and in some areas like cleanrooms these instructions must be hands-free executable with smart glasses.
- Conditional paths and dynamic calculations are essential to assure tasks are done right first time.
- Digital workflow execution logging and system integration offer advantages far beyond perfect compliance and control.
Operators, technicians or researchers carry out plenty of different Standard Operating Procedures or instructions on a daily basis to securely, safely and correctly operate processes and equipment in a pharma or biotech plant. For compliance reasons and as proof of execution instruction forms are often signed off by the person at work.
A document though is not the right structure as most of these Standard Operating Procedures are rather a workflow of step-by-step tasks. Paper-based Standard Operating Procedures or work instructions often fail to do the job.
Moreover, workflow software like Proceedix requires specific features to handle typical instruction complexity and compliance requirements in the Life Sciences Industry.
These 5 must-have features should be on your requirements list :
1. Platform security and validation
A digital SaaS instruction platform typically consists of cloud infrastructure in combination with software both on cloud servers and on mobile and wearable devices for task guidance and execution logging. Therefore, this computerized system must meet the highest quality and security standards in the highly regulated Life Sciences Industry. Active Directory Integration and Single Sign-On are a prerequisite to assure that only authorized members of the organization have access to the platform via secure authentication methods.
The platform must be audited regularly and obtain a SOC2 certification, proving that both organization and system meet the highest standards regarding information system quality and security. When using the pGxP sensitive instructions platform, additional validations will be required to demonstrate meeting GAMP (Good Automated Manufacturing Practice) standards and FDA 21CFR part 11 compliance. While many digital and innovative instruction solutions are emerging, only a few meet even parts of the above standards because of the development cost, time and complexity.
2. UI that displays “snackable” information in a step-by-step workflow and hands-free where needed
Distributed on paper or electronically, the traditional SOP is a document. SOP documents typically written in Word, pdf or on paper, list too many different information elements and tasks on one page. This format requires the user to read, select and focus on 1 task element of the screen or page at a particular time. Most operators or technicians at a reactor or in a lab are not in a comfortable position to both read and concentrate on the equipment and on the specific task. A workflow guiding them step-by-step through the cleaning or calibration tasks, showing only one task at a time, is what deskless workers in a pharma lab or plant need. In some areas like a cleanroom or for some tasks like line clearance, operators and researchers need both hands to do the job.
Allowing for hands-free execution of a workflow with smart glasses is a unique platform differentiator.
3. Conditional paths to enable task guidance based on the situation
Operators and researchers typically control many different equipment parameters regularly to secure both product and process quality. What needs to be done or inspected depends on the status of the equipment, sensor alarms, research protocol requirements and many different factors.
Process engineers and quality assurance managers must be able to formulate conditional paths in a step-by-step instruction workflow. Depending on the answer to a question or the status of a previous task, the operator or researchers should be automatically guided into the relevant path with the appropriate countermeasures or follow-up tasks.
4. Dynamic and system-made calculations to guide the operator
In a pharma or biotech plant, researchers and operators are sometimes required to record input values on specific tasks: e.g. the sample volume consumed. A few steps further down the procedure, a text instruction in the protocol can request them to calculate another parameter: e.g. volume to add to achieve a target sample dilution. The dynamic calculation feature automatically calculates and displays the result instead of requesting it to the operator. The operator can simply confirm that the calculated value was applied correctly. By automating this calculation, valuable time is saved and human errors reduced.
5. Execution logging and system integration offers advantages far beyond perfect compliance and control
Traditional Standard Operating Procedures are implemented by policies and behave as a stand-alone mechanism. A thorough line cleaning is required before starting a new batch on a blister or on a filling line. To ensure this is done, management might ask to sign off the SOP or a related form for “correct execution of instructions” by the operators and archive the result as proof.
One can rely on training, regularly verify the knowledge and at times audit the operator at work. But automatic logging of instruction execution details and operator feedback offers advantages far beyond perfect compliance and control. Execution logs can enrich skill management tracking in the e-learning platform. Systemic issues and opportunities for improvement can be detected through integration with the business intelligence platform. Through a system integration with MES, instructions could be automatically planned and assigned to the operator. Vice versa execution results could be used to enrich the Electronic Batch Record. While there’s a clear need to digitize some instruction workflows and track the execution details, from a broader point of view traditional SOP and procedure documents will remain required to document process knowledge. These documents are governed by QMS (Quality Management Systems) and controlled document management. Integration of QMS and a digital workflow execution platform is a must to assure synchronization between what is “claimed in documents” and what is “instructed and done on a mobile or wearable device”.
