FDANews

Hard Work Worth it for 'Paperless' Labs, Experts Say

Achieving a "paperless" lab takes enormous work, including substantial procedural and possibly organizational changes, but the effort can pay off in a year and provide benefits far beyond 21 CFR Part 11 compliance, experts told PIR last week.

"Overall the benefits definitely outweigh the costs," said George Kuniholm, regional director at CSSC, a regulatory compliance service provider. In addition to enhancing Part 11 compliance efforts, a successful paperless lab program can provide the "strategic benefit" of increased edata visibility, and improved indexing and retrieval of files, he told PIR Oct. 2. But any successful paperless lab strategy must be logical and orderly, he added.

For FDA-regulated companies, a big incentive toward paperless should be the realization that a paper-based system is inadequate to guarantee that lab processes are under control, Kuniholm and Waters Corporation Corporate Compliance Manager Victoria Lander told a CSSC-sponsored seminar in Cambridge, Mass., Oct. 4.

According to Lander and Kuniholm, goals of a laboratory automation system should include:

Enhanced data security; Increased availability and capacity of lab equipment; Remote access to lab data; More meaningful analysis of data collected on different equipment; Elab notebooks with esignature approvals and reduced review cycles; Automated assembly of data into reports and of those reports into submissions; and Improved ease and speed of data retrieval for audits.

The business drivers for paperless labs are compelling, Lander and Kuniholm said.

On the compliance side, a disparate paper-based system poses a "built-in threat" of inaccuracies and transcription errors that expose FDA-regulated companies to "regulatory risk," they said.

On the productivity front, increasing workloads in labs are requiring greater throughput. Information transfer between outmoded systems can be a "significant bottleneck" in analysts' workflow and "may prevent labs from attaining business goals."

In addition, a global approach to lab system integration allows organizations to avoid redundant costs of developing and implementing solutions independently at each individual site, Lander and Kuniholm said. That approach can also promote information content and format standards that permit data to be accessed and used across the organization.

But the challenges to achieving a paperless lab can be daunting, they said. Those include:

The fact that software many not always offer the required security or Part 11 compliance; Stand-alone workstations contribute to point failures and security breaches; and Full automation requires multiple solutions, including acquisitions, archiving, analysis and assembly/publishing.

Companies working toward paperless labs must agree early on where the data should reside. That means defining the authoritative data sources. They must also determine how other systems and users will get access to the data, Lander and Kuniholm said. And it is important to address differences in input standards and entry formats, they added.

They advocate a phased approach, including:

Prioritizing security, then standard formats, then analysis and extraction, and, finally, document management and submission; Using integrated technologies; Creating uniform policies and procedures around the use of those technologies; and Having a level of independence in validation execution and review.

Prioritization is based on risk assessment and investigation of costs/benefits of implementation and long-term use, they said. -- Michael Causey