Increased regulatory advocacy for futuristic workflow techniques is slowly overcoming the pharmaceutical industry’s hesitancy. Valgenesis' Lisa Weeks explains the major benefits
Paper-based validation has remained the norm for decades in the pharmaceutical industry – even though it’s an inefficient and inconsistent bottleneck prone to human error. However, a transition to virtual or remote audits and inspections, coupled with increased FDA advocacy for the use of digital tools, is increasingly showing pharmaceutical companies that digital workflows for validation are not only possible but preferable to paper-based processes.
Despite the clear disadvantages of paper-based validation, many pharmaceutical companies have been reluctant to transition to a modern, digital process. But change is coming. Industry trends and FDA advocacy suggest that the validation process is ready, willing, and able to support digital workflows. Better yet – validation benefits from going digital. Here’s how:
Validation documents created manually must be routed via email (or inter-office mail). Depending on where the most recent version of a document resides, it may not be available for reference for reviewers or software developers. Delays in the routing process are not uncommon and only lead to delays in the development process. Since documents created and routed through electronic workflows are much easier to share, teams can enforce requirements throughout the development lifecycle instead of scrambling to do so at the end.
Paper-based workflows require manual transcription of data that is then entered into a word processing or spreadsheet application and then printed, collated, put in a binder, and archived. This is a significant amount of low-skill work for highly skilled QA staff. Digitising data collection eliminates these unnecessary steps, giving reviewers more time to focus on high-value work such as risk assessment.
Manual analysis of validation documents – poring over paper or searching through word processing documents and spreadsheets – is time-consuming. Even the most seasoned reviewers will miss something. Machine learning algorithms can be deployed not only to search, sort, and analyse the data in digital documents but also to identify trends, all in a matter of minutes. This allows reviewers to use their expertise to address anything that looks amiss, from a glaring error to an empty row in a spreadsheet.
The paper-based review process is largely passive
Only one reviewer at a time can work with a paper document. For effective version control, the original reviewer’s comments should be incorporated before the document is passed to the next reviewer. Putting more than one copy of the document out for review at the same time only complicates the process. With digital validation, multiple reviewers can author and edit a document simultaneously, and version controls indicate who made which changes at which times. This expedites the review process while automatically creating an audit trail.
The paper-based review process is largely passive, as reviewers must wait for a document to arrive in their mailbox or inbox. Digital validation workflows provide real-time alerts – indicating not just that a document is ready for review but also highlighting the necessary tasks the reviewer is required to complete. Reviewers who can’t complete a task can decline the work in real-time, allowing those managing the review process to transfer those tasks to another reviewer and avoid costly delays.
In paper-based workflows, requirements and traceability matrices are treated as an afterthought, often assigned to junior-level staffers toward the end of a project. This poses a significant risk that something will be missed, given the complexity of the work coupled with its time-sensitive nature. Digital workflows maintain these important resources as a validation document is completed, making the review and the soft software testing processes more efficient and accurate.
Handling deviations and exceptions manually requires a paper-based documentation process that’s separate from the review itself. This is time-consuming, and it quickly becomes difficult to track. Digital workflows can help reviewers manage deviations concurrently, speeding up the execution process. Digitisation also makes it possible to trace each deviation activity and identify and amplify the impact of each validation change, further ensuring that issues don’t go unaddressed and that companies produce a compliant, high-quality product.
In paper-based workflows, reviewers can’t do their work if they don’t have a physical copy of a document. At the same time, a manually created document can easily get lost in the mail or emailed to the wrong person, creating immediate security concerns. Through digital validation, documents become a secure, single source of truth with role-based access controls that restrict who can view, edit, or sign. When access becomes virtual, untethered to physical locations, companies can adopt a “follow the sun” collaboration model that saves even more time.
Review and revalidation are critical steps, but manual workflows make it difficult to keep these processes on a tight schedule. Not only are companies working with paper documents that are typically generated as a one-off for each project, but there’s rarely a common calendar indicating when review and revalidation work must take place. By combining a dynamically generated calendar with real-time alerts, digital validation workflows ensure that companies don’t miss upcoming reviews and revalidations – and can staff for them accordingly.
Paper documents are easily misplaced or destroyed. Additionally, the lack of version control makes it difficult to determine which document is stored at which site – or sitting on which desk – is the “version of truth.” Digital documents that are backed up frequently, stored in the cloud, dispersed geographically, and used within highly fault-tolerant systems resolve the easily preventable business continuity and disaster recovery concerns of paper-based validation workflows.
Maintaining consistent document templates, collecting feedback from multiple reviewers, and locating physical documents for auditors are some of the biggest challenges of manual validation workflows. Digitisation supports workflow standardisation from document creation to submission, while digital audit trails indicate when changes were made and by whom. This ensures compliance throughout validation, as digital workflows align both the development process and the finished product with the necessary regulatory requirements.
Regulatory compliance is certainly important, but so is software quality. Given the significant investment of time and resources in gathering paper-based evidence for auditors, the pharmaceutical industry has tended to put compliance first. The focus on quality and risk management has been lost in the process. Streamlining the validation process through digitisation and automation gives reviewers more time to apply their critical thinking expertise to validation – ensuring that products are not just compliant but also safe and effective.
This article is a post from Valgenesis’ blog that has been republished with permission.