In an effort to enhance consistent quality, address data integrity challenges, reduce costs, and minimize risk, Life Science companies are seeking to optimize their Validation processes. In doing so they naturally consider going paperless and typically look at an existing IT system, before considering a built for purpose paperless validation solution.
Internal IT systems are usually hybrid systems that leverage an existing document management system (DMS) or product lifecycle management system (PLM). Typically, you create a protocol in word, review/approve in the DMS/PLM, print to paper, execute using wet ink, manage and close deviations/issues, write reports, scan completed records back into the DMS and physically file. Because these systems are not designed specifically to manage Validation and GxP testing they will only provide a small portion of the benefits that an Electronic Validation Lifecycle Management Solution (eVLM) will deliver. Those who adopt hybrid systems realize limited improvement and subsequently end up cycling back to explore a purpose-built eVLM solution. As an analogy, think of trying to do Electronic Batch record execution using your DMS. While a good DMS will help with good management of the master record (review/approval/change etc.), it will not enable electronic batch record execution and so it cannot become a paperless process and deliver the associated benefits.
Limitations of Hybrid systems:
- Manual paper based supported by central document storage and some element of review and approval
- Mimic paper based systems as mass printing, manual handling activities, paper execution, scanning, filing etc.
- Only wet ink GxP test execution, cannot go paperless
- Verifying that all requirements have been tested is a manual paper chase and Requirement Traceability Matrices are difficult to build and maintain manually
- Manual building of documents and packs is still required
- No metric based reporting such as document, project, system Validation status etc.
- No call to action, traceability and visibility capabilities
- No automation of tasks or true collaboration on individual documents or the process at large
- Require continuous procedure driven management and are very difficult to scale across sites
- No real-time visibility into Validation projects, periodic reviews, requalification, etc.
In essence, hybrid systems are limited work around, and only deliver a small portion of the potential benefits. On the other hand a purpose-built paperless validation solution can offer the following.
Purpose-Built Paperless Validation Solutions:
- Provide complete end-to-end paperless control over the entire process
- Designed to meet regulatory Data Integrity expectations – “ALCOA”
- 100% template management through creation, review, parallel collaboration, version control, approvals, etc.
- Auto-generation of Validation documents and full system Validation packs
- Streamline and automate process steps, including notification, alerts and updates
- Eliminate all manual handling associated with documents, deviations, reports
- Provide seamless transition from protocol development to approval to release for paperless execution to post review and approval – i.e. 100% paperless
- Real time automatic generation of Validation summary reports
- Auto generate Requirement Traceability Matrices
- Global access to any site Validation Index, Validation Status Information & Validation Records. Instantly know the Validation status of all assets based on actual work complete
- Allow Validation process templates and document templates to be seamlessly shared across projects and sites - cross-site Validation process alignment. Central best practice structure that can be leveraged globally
- Audit ready – centrally access data and records instantly from any device, never misplace a record or its data at any stage of its lifecycle
- Accessible via web-browser and touch enabled devices
- Can be deployed on-premise or from a regulated SaaS environment
If your organization is looking to enhance quality, reduce costs, and minimize risk a purpose built Paperless Validation Solution is the right choice. These next generation solutions are proving to the market that so much more can be achieved, delivering productivity gains in excess of 100% and reducing cycle times by 50%. As you start your continuous improvement project, consider the vision you desire and evaluate an end-to-end paperless validation solution built for purpose, that can deliver this vision.
Kneat develops and markets the next generation Kneat Gx software platform. It enables Life Sciences to become fully paperless with their many Validation and testing processes, from Paperless Validation and Manufacturing through to C&Q and Quality Document Management. Our customers are achieving productivity increases in excess of 100%, cycle time reductions of up to 60% and a higher repeatable Quality and Compliance standard.