Matt Lowe

In 2019, the failure to document quality responsibilities and procedures was the top citation in the Form 483 reports issued by FDA. The next most common inspection finding citation related to compliance with good manufacturing practices (GMP), moving up from its third-place position in 2018, was failure to thoroughly review unexplained discrepancies or failure of batches to meet specifications (1). 

These are all common lapses that start small but lead to major compliance roadblocks for life-sciences companies of all sizes. The reason for their occurrence can be easily explained: manual processes are the biggest threat to compliance with GMP requirements. Making the case that paper is the greatest enemy of GMP compliance and the leading cause of the escalating cost of quality is not difficult.

Many pharmaceutical companies continue to use paper-based processes on the manufacturing floor despite inefficiencies created by burdening resources with paperwork and slow manual processes. Other issues—many not immediately evident—contribute to higher quality costs, including the following:

There is no efficient (let alone automated) means of consolidating data within a paper-based system.

Data that are manually collected from and entered into paper documents are inherently limited.

Information contained in manually compiled audit trails is time-consuming to retrieve during audits and inspections, if it can be located at all.

Manually tracking, approving, and recording GMP-related documents increases the likelihood of misunderstandings and human errors, all of which slow an organization’s cash flow.

Manual reviews of the documentation required for GMP compliance tend to delay lot releases.

Training is harder to administer in analog systems and harder still to record and track efficiently.

A reliance on paper documents has also caused many life-sciences manufacturers to shift from providing meaningful training for employees to simply allowing them to check a box on a paper form indicating that a work instruction has been read and understood. These practices can result in human error, illegible handwriting, and lapsed training.

For most companies subject to GMP requirements, proof of compliance has always been associated with boxes of paper records. Paper documents—and later PDFs, which can be equally as problematic to extract data from—have historically been hallmarks of GMP compliance.

The future of GMP compliance lies in digital data connectivity. Life-sciences companies that have implemented paperless solutions are finding it is possible to extend digital advantages from the back offices to the shop floor and beyond.

For example, a pharmaceutical packaging company that employed a cloud-based batch record system reduced GMP-related quality reviews from two to three hours per batch record to 10–15 minutes per record and increased employee efficiency by 30% (2).

Digital systems that automatically contextualize intelligence can provide company leaders with information to make better decisions and provide recommendations in real time. Other GMP compliance advantages that can be achieved by digitally connecting quality data and processes include:

. A digital quality management system (QMS) can maintain updated GMP records so that they are continually primed for audits.

. A digitized QMS that automatically distributes reminders about important tasks like document approvals and late training tasks sustains the progress of quality. Additionally, it helps maintain trust throughout the organization that quality processes are always headed in the right direction.

. Automation helps ensure training is appropriately administered, completed, and recorded.

. Digital records can be easily retrieved during an inspection, providing inspectors with faster access to complete, correct information.

. Digitization affords real-time reporting capabilities that empower decision-makers to act quickly with the knowledge that their information is accurate and up to date.

. The ability to catch mistakes and see bottlenecks quickly brings quality issues to the fore sooner so they can be addressed with speed and precision.

Many companies can claim to be fully digitized, but if various departments are using disconnected systems, each team is typically reliant on siloed information, which makes it impossible to extend quality throughout the enterprise. There should never be a question of “Whose data are the right data?” When they are not coming from the same source, the data will undoubtably be inconsistent, which leads to disagreements.

A common software platform is the key to connecting people with the processes and policies that are integral to GMP alignment. Platforms are vital to eliminating the antagonistic mindset that too often thwarts cross-departmental compliance efforts.

A unified platform that digitizes and integrates processes enables a company to collect, connect, and contextualize the metrics, data, and insights needed by both manufacturing and quality teams. It puts both departments in a better position to conduct shared processes that directly correlate to GMP compliance, such as document revisions, training, sampling and testing, and review and release.

Aligning GMP activities across a broader ecosystem

For companies with geographically dispersed partner/vendor sites or business units, ensuring consistency is one of the most difficult aspects of GMP compliance. But maintaining quality alignment across a network of sites in diverse geographic regions where different languages may be spoked is an uphill battle that’s made even harder without the support of a centralized QMS.

Paper-based or hybrid paper/electronic systems can slow the process of developing key compliance documents, such as standard operating procedures, policies, or work instructions. A centralized quality management system promotes collaboration and more rapid completion of quality documents.

A digitized QMS doesn’t just make good business sense. As the regulatory world becomes increasingly more digitized every day, it makes good compliance sense for companies that must conform to GMP requirements.

Seeing the writing on the wall—or, in this case, on the digital screen—FDA is in the process of updating its own technical infrastructure via the Technology Modernization Action Plan (TMAP). The plan is not just aimed at keeping up with digital trends, however. It is intended to improve the agency’s communication and collaboration with the companies subject to its regulations in order to drive technological progress that can improve patient outcomes. FDA has made it abundantly clear that the TMAP strategy revolves around data because connected, contextualized data represents the regulatory future. The plan’s foundation is the concept of making dramatic improvements in the “stewardship, security, quality control, analysis, and real time use of data” (3). Even regulators understand that the time has come for data to take center stage, and FDA is leading the data connectivity charge.

As life-sciences companies and regulatory bodies alike become more digitized, their systems for managing quality are the cornerstone elements that can least afford to remain analog. Not adopting the latest technology is a risk no business can afford. Just ask the former Blockbuster executives who didn’t make the leap to a streaming platform and ultimately went out of business. When it comes time to prove compliance with GMP requirements, the companies that follow FDA’s lead in the area of QMS digitization and data connectivity will have distinct advantages over competitors that still rely on siloed information trapped in paper-based systems.

, accessed Sept. 17, 2020.
2. Master Control, The Ultimate Guide to Digitizing the Shop Floor, White Paper (2020).
3. FDA, “FDA’s Technology Modernization Action Plan,” 

Matt Lowe has served MasterControl as a product manager, senior vice president, and president of MasterControl Labs.


Vol. 44, No. 10
September 2020
Pages: 62–64

When referring to this article, please cite it as M. Lowe, “

Viewpoint: Digitizing Processes to Align with GMP Requirements

Articles

The case for migrating from a paper-based quality management system to a digital platform is presented.
