- The journey of procedures from application to issuance to formalisation
- The difficulties of a paper-based or hybrid journey
- Supporting digital in a system cfr 21 part 11 Compliant and integrated with other processes
Procedures are the backbone of life science companies, but also their “thorn in the flesh”.
Procedures are essential because they ensure compliance with quality and safety standards, define processes, clarify responsibilities, roles, activities to be performed and prevent errors. With each change of process, technology, new regulations, new product launches, the procedures must be updated, as well as the related documents and forms.
The journey of a procedure
From the application stage to the formalisation stage, the procedures follow a real journey.
The Stages of the Journey
At this stage, approval is sought to issue a new or updated procedure, stating what the reasons are. Only after approval can the drafting begin.
The drafting and updating phase can be very demanding, as it requires great attention to detail, clarity of presentation and knowledge of the relevant flows and regulations. To understand the importance of this, just imagine what could happen if, in the artwork management procedure, the code on the packaging was not checked against the material code entered in the system. A small oversight, which could lead to repercussions at the freight entrance.
Procedures can be written by each department with the support of the QA. A standard format is usually used to write them.
After the drafting phase, the procedure in draft form continues its journey into the revision phase. Here you highlight any errors, add or omit information. This phase can involve several actors in the company at various levels and can also last a long time in rework and approval signatures.
Once the review of the draft is complete and changes have been made, the responsible actors sign the document and the procedure changes status to approved.
Depending on the impact, before a procedure is formalised, it may be necessary to train staff on the new instructions, processes, activities to be followed. The training phase can be carried out online or offline in the classroom. The execution of this phase should be tracked and recorded.
After approval with the signatures of the responsible persons and possible staff training, the procedure can be made official. If the new version replaces the previous one, the latter becomes obsolete and must be withdrawn.
The Paper Journey
The journey of a procedure is not all sunshine and roses most of the time, and at each stage there can be changes of gear, turnabouts and restarts.
Imagine how stormy the paper or ‘hybrid’ journey can be, the draft travelling between emails, between offices, between network folders, full of comments and corrections. Then it lands on the desks of the responsible actors overflowing with documents, waiting for a coveted signature to leave, and the owner on the other side anxiously soliciting approval.
Not to mention the training, especially when it involves most of the resources in the company, with forms to be filled in, people absent from work, and those who cannot attend the classroom.
The Digital Journey
The digital journey can also be bumpy, because technology is still driven by people, but thanks to notifications, automatisms, electronic signatures, real-time information sharing, linking to other processes, e-learning training and much more, there is a great advantage in terms of time, control, traceability and the mental well-being of the SOP owner.
Digitising an SOP within a single compliant system, such as PRAGMA 4U, means accompanying the owner and the actors involved in a fluid process from the drafting to the officialisation of the document, in a centralised digital archive that can be accessed anytime and anywhere by authorised personnel.
Why does the journey of procedures improve in a digital platform? (10 Reasons)
There are at least 10 reasons why using a platform that digitises document management and integrates it with other processes in a single system will improve the efficiency and productivity of your business.
- The approval of procedures will be faster with electronic signatures, which can be affixed anywhere, even if not present.
- Procedures will always be updated automatically, replacing the previous outdated version
- Stakeholders will receive automatic notifications and alerts to be notified of SOP review and approval
- The SOPs, each with its own ID, will be organised and the search facilitated thanks to specific filters
- The SOPs will be centralised and available anytime and anywhere to authorised persons both inside and outside the company
- It will be possible to connect the procedures to other processeson the platform and integrate with systems, such as e-mail. For instance, training can start automatically when the procedure is approved and when all resources have completed the training, the SOP will automatically become official, replacing the previous one.
- Your data and documents will be safe, in compliance with the regulations. Access is only to authorised persons and with various levels of viewing or editing. Every process can be easily monitored and any activity tracked (Audit Trail), even document printouts
- The history of the procedures will always be available in real time, thearchive protected and safe with data backup and disaster recovery plan
- Increased productivity. Print costs are reduced, but so is the time spent on resources such as signature turnaround, scanning, emailing or searching for documents in the archive.
- Increased collaboration and information sharing with standardised and clear processes in one system.