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Table 3: GMP Regulatory Requirements for Data Integrity Instruments must be qualified and fit for purpose

Software must be validated Any calculations used must be verified Data generated in an analysis must be backed up

Reagents and reference solutions are prepared correctly with appropriate records

Methods used must be documented and approved Methods must be verified under actual conditions of use

Data generated and transformed must meet the criterion of scientific soundness

Test data must be accurate and complete and follow procedures

Data and the reportable value must be checked by a second individual to ensure accuracy, completeness and conformance with procedures

the copy/paste function losing all associated metadata links, creating a data integrity nightmare.

REDUCE AND SIMPLIFY WORKFLOW COMPLEXITIES Simplifying scientific processes will significantly reduce data integrity problems. While this industry is trying to harmonise scientific processes, other regulated industries are ahead in this field, so applying common best-industry-processes is still a dream. However, there are signals that this industry is recognising the need. For example, suppliers of balances and titrators are increasing the value of their instruments by implementing approved and pre-validated methods and industry best- practice workflows in their firmware. Almost all major balance suppliers allow methods to be implemented directly in their balances and other wet chemistry instruments. This may seem a small step, but it can significantly reduce the effort involved in validation of integrity, since these methods reduce the number of failure points during operation and thus the need for customisation. Another example is the proven integration

of LIMS processes with enterprise (ERP) workflows. A significant reduction in the frequency of data integrity issues can be achieved by creating consistent workflow integration between both systems. Process harmonisation will initially increase the validation burden but, in the long run, the effort will pay off. The continued elimination of manual control activities will reduce the number of potential data integrity failure points and boost efficiency of laboratory staff and management.

8 |

[§211.160(b), §211.63] [§211.63]

[§211.68(b)] [§211.68(b)] [§211.194(c)]


[§211.194(a)(2)] [§211.160(a)]

[§211.194(a)] [§211.194(a)(8)] Derived from the laboratory data integrity definition and the applicable 21 CFR 211 GMP regulations – FDA’s Focus on lab Data integrity – Bob McDowall Part 1 A final example of how the industry is

recognising the need to apply best practices is the approach of mapping the entire laboratory workflow4

and related operations, from

sample receipt to release of results, the benefit being consolidation in operational workflow. The overall net effect will be a reduction in validation effort and decreased data integrity risks.

ADOPT AND USE INDUSTRY STANDARDS AND PROCESSES The American Association of Pharmaceutical Scientists (AAPS) produces guidance on Analytical Instrument Qualification (AIQ) in the form of a white paper, which has been incorporated as General Chapter <1058> within the United States Pharmacopoeia (USP). A proposed update has recently been issued for public comment. The changes that are proposed will have a positive impact on the AIQ process of analytical instruments and laboratory computerised systems5

deliverables of the foundation – sponsored by industry leaders such as Pfizer, Abbott, Amgen, Baxter, BI, BMS, Merck, GSK, Genentech, Roche and others – are an extensible framework that defines a common standard for data representation to facilitate data processing, data exchange, and verification. Allotrope’s vision of the laboratory of the future aligns closely with FDA’s regulatory objectives6


BETTER COMMUNICATION Communication is a common dominator and often underestimated as a significant point of failure in multidisciplinary laboratory automation projects; but it is also a critical element to reduce data integrity challenges within organisations. Workflow simplification and the adoption of industry best practice pre-defined workflows will reduce complexity. Modern tools such as LIMS, ELN, LES and mobile devices such tablets are married to each other. However, to connect a balance still needs an IT professor. The challenge to the industry is to make pairing a balance with a computer or tablet using a laboratory software application as simple as connecting a phone in your car. Lowering the barrier to integrate instruments will contribute to lowering data integrity challenges in laboratories significantly.l

. A practical

reality is that a computerised system cannot be validated without qualifying the analytical instrument, and vice versa. A serious concern is the lack of data

standards in the scientific community. Without standards, data integrity will remain challenging and auditing and verifying is an expensive exercise. The Allotrope Foundation is an international not-for-profit association of biotech and pharmaceutical companies building a common laboratory information framework for an interoperable means of generating, storing, retrieving, transmitting, analysing, and archiving laboratory data and higher-level business objects such as study reports and regulatory submission files. The

Peter Boogaard is an independent laboratory informatics consultant and founder of Industrial Lab Automation, which provides services to address harmonisation, integration and consolidation of business processes in development and manufacturing. Industrial Lab Automation organises the Paperless Lab Academy, for which Scientific Computing World is media sponsor. Taking place in Barcelona, the 2016 event will focus on finding the speed to innovate. The Paperless Lab Academy is the ideal learning platform, for those considering consolidating, integrating and simplifying laboratory data management systems. There is no conference fee for industry delegates.

References 1


FDA - 21 CFR 11.3(b)(6) guideline

FDA Pharmaceutical Quality/ Manufacturing Standards (CGMP) Guidances GuidanceComplianceRegulatoryInformation/ Guidances/ucm064971.htm

3 4 5

ISPE International Society for Pharmaceutical Engineering -

Introducing a paperless Lab – http://

Life Cycle Risk Assessment of HPLC Instruments - Paul Smith and R.D. McDowall - LCGC Europe, Volume 28, Issue 2, pg 110-117 www. assessment-hplc-instruments


Allotrope Foundation - IPQ Monthly Update (Jan/ Feb 2015 pp 11-14).–

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