Before diving into the topic of paperless validation in the pharmaceutical industry, the fundamentals of Good Documentation Practice (GDP) shall be reiterated. Data integrity, arguably the most discussed topic, is the bedrock of GDP in any form of record – paper or electronic. ALCOA+ (a mnemonic) is a set of principles that ensures data integrity. It was introduced by, and is still used by the FDA – the US Food and Drug Administration. While this article will not discuss in detail the principles of ALCOA+, it is necessary to mention the set of principles as a precursor to describing paperless validation.
What are the ALCOA+ principles?
ALCOA is an acronym for the original five principles of data integrity, which are Attributable, Legible, Contemporaneous, Original, and Accurate.
The original ALCOA principles have since been updated to ALCOA+, adding the following four principles, which are Complete, Consistent, Enduring, and Available.
What is the driver for a paperless validation solution?
In a regulated environment, the mantra is, “what is not documented is not done”. In many regulated industry organizations, the de facto method of documenting the work performed is almost always paper. Strong regulatory oversight and the absence of suitable alternative technologies have dampened the enthusiasm to move away from the current word processing environment.
However, with the industry pushing for a more efficient and leaner means while remaining compliant to the regulatory requirement and expectations, the documentation has become more complex. The struggle to generate and maintain complex documentation, for e.g., User Requirement Specifications (URS), Quality Risk Assessment (QRA), System Impact Assessment (SIA), Commissioning and Qualification (C&Q) Protocols, Requirement Traceability Matrix (RTM), etc. is very real. Amongst the struggles include the following:
- Document generation is labour intensive
- Documents are of different quality and format
- Adherence to corporate and regulatory standards
- Ensuring consistency and accuracy of repeated data across different documents.
- Data integrity
- Management of change
A compliant database solution that adopts a document-centric approach and offers all the benefits of robust data management in a familiar, tried and tested documentation environment is needed to meet the requirement of a leaner, more efficient, and compliant validation execution. Herein enters the paperless validation solution!
Paper-based versus paperless validation approach
The immediate and apparent benefit of paperless validation is the reduction in, and ideally the elimination of paper-based validation documents. Let’s take a look at the following traditional approach, where at each step, some amount of paper-based activities are required.
The following narration is not exhaustive but will give you a rough idea of the discussion point.
Imagine a scenario where you are tasked with creating a test plan. The first instinct is to dive into your “stash” to find the supposedly best version of a similar system. The downfall of this approach is that the document generated could be of different quality and format from another person within the same organization. The harmonisation of the content, look and feel of the document immediately becomes a challenge. As opposed to a paper-based approach, the document templates, approval templates, test scripts with SME-approved acceptance criteria, etc. could be controlled (audit trail, version-controlled, and access-controlled) using a document-centric paperless validation system.
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With a paper-based approach – more often than not – the reviewers may want to have the draft document printed out, commented on and returned to the author for incorporation, and then repeat another round for wet-signature pre-approval. Cumulatively, the sheer amount of printing paper wasted, the time taken to track the movement of documents in various stages, including the actual physical effort to move them and chasing down the reviewers/approvers translates into resources (time and money) wasted – a necessary waste in a paper-based approach.
With a 21 CFR Part 11 compliant paperless solution, the review and pre-approval process could be done electronically including tracking for project management – immediately providing tangible savings!
Coming to the execution of the paper-based pre-approved test plans, the hand-written document(s) are subjected to various Good Documentation Practice (GDP) and Data Integrity (DI) issues, whether intentional or otherwise. However, with a purposefully built 21 CFR Part 11 compliant paperless solution, all entries are tracked with a full audit trail and electronic signature applied. Cross-referencing in the execution documents to the URS points could be made towards an automated Requirement Traceability Matrix (RTM) generation. It is sometimes forgotten that a paperless validation is a regulated computerised system in and of itself.
Challenges of the paperless validation solution
Implementing a paperless validation solution isn’t the magic bullet to a less than ideal documentation practice OR a poorly thought out process within an organization. The chosen paperless validation solution is a tool that could assist in ensuring the consistency in approach (harmonisation, templates, etc.) and having design features built into the application to assist as much as possible in managing document preparation and execution, ensuring that they are better managed and subsequently better for retrieval for any reasons and/or purpose.
Second, is the commitment from top-tier management to drive the organisation to overcome the “we’ve always done it this way” mentality, and encourage them to embrace a better way of doing things. As briefly discussed in the previous paragraph, a paperless validation solution isn’t a magic bullet and there is no one solution that is perfect. However, the cost-benefit analysis will almost definitely point towards a cost saving if the “fit for intended use” paperless validation solution is selected with the same thought process as one would use in an equipment qualification – which is defining the User Requirement Specification (URS) for the paperless validation solution.
Third would be how to start the transition from a paper-based to paperless validation solution in an established organization. By starting small and structuring a “Proof of Concept (PoC)” with the paperless validation solution vendor, one could implement the transition in a controlled manner by incorporating the lessons learnt when scaling up or out. In this way, the culture could slowly be introduced and competency built, level by level. Remember, Rome wasn’t built in a day.
There is no denying that with more complex documentation, practices to achieve more efficient and leaner execution than a compliant database solution that adopts a document-centric approach will be needed going forward. Choosing the right paperless solution vendor with a proven track record will assist in the successful adoption of the technology, replacing the outgoing cumbersome load of the paper-based approach. The journey to full adoption of paperless validation would be bumpy but if kept at, the savings would be over ten-fold!
Lastly, I will leave you with some key considerations and questions for thought when selecting a paperless validation solution:
- How compliant is the paperless validation solution to FDA 21 CFR Part 11 and Eudralex Volume 4 Annex 11 including user management, audit trail, etc?
- What is the limitation in its scalability across multiple sites?
- What is the vendor experience in a GMP regulated environment?
- Does the paperless validation solution have the capability of progress reporting in real-time i.e. document status against the project, system owner, etc?
- Does the paperless validation solution have the capability to ensure harmonisation of the approach and what is the control over it?
- Does it have review and approval functionality built-in?
- Does it have an electronic test-execution process?
- Does it auto-generate validation summary reports?
- Will it offer validation storage, search, and retrieval?
Now that you know about Paperless Validation, it might help to know why pharma companies need paperless validation.
At No deviation, we are partnered with Kneat Solutions, the leading validation software solution for the life sciences sector. The No deviation-Kneat Solutions partnership enables us to work strategically with organizations to comprehensively map, configure, optimise and digitise work processes to KneatGx™, a feature-rich paperless validation platform. It also helps us support deployment and provide ongoing support, whether it is a single process at one site, or involves large scale deployments covering multiple sites and numerous users.
Reach out to us for a full risk-based paperless validation with integrated commissioning and test plan or to bring efficiency to your existing paper-based IQ, OQ execution. You can also visit our website for more information on our services.
