EDITOR’S NOTE: In this first installment of a two-part series, we cover the 12 biggest reasons pharma manufacturers should make the switch from paper-based to digital validation now.
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:
#1. Create, Route, and Enforce Validation Documents Electronically
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.
#2. Expend Less effort Recording Data
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. Digitizing data collection eliminates these unnecessary steps, giving reviewers more time to focus on high-value work such as risk assessment.
#3. Spend Less Time Analyzing Data
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 analyze 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.
#4. Let Multiple People Author and Review Documents
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.
#5. Reviewers Receive Alerts When Action is Required
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.
#6. Maintain Requirements and Traceability Matrices Electronically
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.
Read the second installment of this two-part blog post series here.
This blog post is an excerpt from "The playbook for truly paperless validation in pharma." To download the entire playbook, click on the link below.
