#paperlessvalidationsoftware

Companies in the life sciences industry face challenges in developing and maintaining data integrity due to complex validation documentation. Maintaining data consistency, accuracy, and integrity across many documents can be challenging.

Recently, notable data integrity violations occurred in global pharmaceuticals, biotechnology, and life sciences organisations giving rise to complex data validation in the creation of medical treatments that cure or prevent disease.

As Data integrity requires a daily commitment to safeguarding information, it is challenging for life sciences businesses. Data accuracy and reliability are key priorities for regulatory agencies like the FDA. Data integrity problems can be detected and prevented with the aid of flexible, risk-based strategies provided by CGMP guidelines.

Companies should deploy meaningful and effective strategies for reducing data integrity risks based on their process knowledge and knowledge of technologies and business models. To maintain the safety, efficacy, and quality of drugs as well as to protect public health, firms should ensure that CGMP violations are not committed.

What is Data Integrity?

Data integrity is high-quality, accurate, and totality of data as it is maintained over time and across formats. Preserving the integrity of the FDA-regulated industries’ data is a constant process as it ensures the quality of the product.

The FDA Data Integrity requirements are summed up by the acronym ALCOA.

ALCOA is a collection of principles that ensures data integrity. ALCOA is the acronym of Attributable, Legible, Contemporaneous, Original, and Accurate.

Data Integrity demands that information be collected, documented, and reported in a way that accurately, truthfully, and completely represents the original.

Data integrity can be preserved through Good Documentation Practices (GDPs). There should always be data integrity at the core of any record – whether it is paper or electronic – and it is, undoubtedly, the most researched topic within life sciences.

Traditional-vs-Paperless Validation

Traditionally, validation or documentation of works performed ( for example equipment, computer systems, and processes) has been done by writing important data on certified printed test documentation according to the FDA regulations.

It typically involves getting wet-signature approvals at various stages. Thereafter, the records are kept and archived for the appropriate period of time before being discarded.

Printing, scanning, archiving, reviewing, and approving validation papers are worthless and consume a large number of resources. The inefficiencies that plagued paper-based validation processes are eliminated with paperless validation solutions.

Paperless Validation

The advantages of paperless validation: the uniformity of content, look, and feel of the document is possible to meet the requirement of a leaner, efficient, and compliant validation execution.

It incorporates all system components online, including document generation, review, execution, approval, and storage. The validation tests are conducted using software tools that enable real-time data to be recorded.

A well-integrated system would also enable correlation between regulatory data integrity standards and protocols without requiring physical copies as proof. Approvals may be issued electronically. Storage and archiving of data would eliminate physical storerooms and the need for space for storing records until they are no longer needed.

The purpose of a paperless validation solution is to ensure consistency in approach (harmonization, templates, etc.), as well as include features to assist in document preparation and execution, ensuring that they are better managed and can more easily be retrieved.

Advantages of Paperless Validation:

Increased Compliance: Organizations will face fewer regulatory concerns and data integrity will improve.

More productive work: ‘Doing it right the First Time’, Reducing compliance time, making projects agile, and having a “knowledge database”

Lower validation costs: The traditional validation costs like printing paper waste are eliminated, time and physical effort to track the documents is reduced, physical storage space for documents, printing, and scanning costs for documentation can be avoided until the required time. This can be considered a sustainable approach as no paper, no printers, no cartridge is disposed of.

Collaborative work: Connecting teams from different countries and data/records are immediately available to all resources involved in clinical research/validation.

Easier validation status maintenance: With frequent updates and periodic inspections, the time it takes to maintain validation status is reduced.

Easier audits: Data is immediately available.

Paperless validation software reduces your team’s workload, allowing you to save up to 65% on the validation process.

Several paperless validation software programs support the entire application lifecycle, and pharmaceutical firms have begun taking advantage of them. Through paperless validation tools, the entire CSV/CSA life cycle is digitized, enabling productivity, cycle time, and compliance improvements.

The application lifecycle management software allows you to manage the whole validation process including the analysis of user requirements, the design and implementation of IQ, OQ, and PQ protocols, the generation of traceability matrix, and the generating of Validation Summary Report in one easy-to-use application.

There are plenty of new paperless validation solutions available that support Computer Software Assurance. Implementing paperless execution reduces GDP errors and improves data integrity by ensuring standard functionality that complies with ALCOA.

Summary:

Bird-brained. Has anyone ever been called that? It’s definitely not a compliment. However, a bird’s eye view is considered good, like being in the crow’s nest or traveling straight as the crow flies. Pretty as a peacock? That’s good too. As I look out my window, the bird songs that abound are enjoyable, and I’m no ornithologist.

What do birds have to do with Paperless Validation for the Bio-Sciences? The bio-sciences are all about saving lives, so there’s definitely a connection here. Paper comes from trees, and the more we can go paperless, the more habitats for birds we can save!

For those in the bio-sciences, I applaud you. I also applaud those who have created software that allows us to go paperless across many industries. Let’s take a look at some mechanisms that allow for paperless validation.

The fundamentals of Good Documentation Practice (GDP) are essential in the industry. 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.

ALCOA was introduced by and is still being used by the FDA. ALCOA is an acronym for the original five principles of data integrity: Attributable, Legible, Contemporaneous, Original, and Accurate. The original ALCOA principles have since been updated to ALCOA+, adding the following four principles: Complete, Consistent, Enduring, and Available.

To create a more efficient and leaner means while remaining compliant to the regulatory requirement and expectations, the industry has evolved into documentation that has become more complex. The struggle to generate and maintain complex documentation, for example, 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 intensive

Documents are of different quality and formats

Adherence to corporate and regulatory standards

Ensuring consistency and accuracy of repeated data across different documents.

Data integrity

Management of change

What is Paperless Validation?

Simply put, it’s a way of ensuring things reach compliance electronically. This includes software, utilities, equipment, spreadsheets, and processes. It also includes a series of tests in Life Science companies to comply with regulatory bodies such as the FDA, EMA, WHO, and more.

As an example, 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 with an existing test plan. 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 harmonization of the content, look and feel of the document immediately becomes a challenge. Unlike 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.

With a paper-based approach, the reviewers typically want to have the draft document printed out, commented on, returned to the author for incorporation, and then repeated another round for wet-signature pre-approval. Cumulatively, the amount of wasted paper, the time taken to track the movement of documents in various stages, including the actual physical effort to move them and chase 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!

Lastly, here are some key considerations and questions for thought when selecting an electronic/paperless validation solution:

How compliant is the paperless validation solution to FDA 21 CFR Part 11?

What is the vendor experience in a GMP-regulated environment?

What is the limitation in its scalability across multiple sites?

Does it have review and approval functionality built-in?

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 harmonize the approach, and what is the control over it?

Does it have an electronic test execution process?

Will it offer validation storage, search, and retrieval?

Does it auto-generate validation summary reports?