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www.biopharminternational.com October 2020 BioPharm International eBook 23 Regulatory Sourcebook Data Integrity with data collected and recorded on paper by observation. Figure 3 shows a range of ana- lytical procedures that could be found in a pharmacopeia, from tests by observation to complex chromatographic or spectroscopic methods. It also highlights some of the main data integrity issues associated with the different ana- lytical methods. Methods involv- ing USP <1058> Group C systems (18), typified by chromatographic and spectroscopic methods, are shown in green. If the applica- tion software has adequate tech- nical controls (e.g., definition of user roles, audit trails, etc.) and it has been configured correctly t o p r o te c t e le c t r o n ic r e c o r d s and w ith separation of roles to avoid conf licts of interest, then the protected electronic records a nd a sso c iate d rep or t s e n su re data integrity. These features are not usually found in hybrid and paper-based records. It is t he a na ly t ic a l met ho d s and records shown in yellow in Fi g u r e 3 t hat a re t he cent ra l to the authors' question: "Do phar- macopoeias inadvertently facil- itate data integrit y v iolations?" T hese a na ly t ic a l met ho d s a nd records vary from simple obser- vat ion (e.g., color, appea ra nce, odor, classical titration) to instru- me nt a l a na ly sis d at a re corde d on paper (e.g., LOD). While the main emphasis of the regulatory guidance documents listed in the i nt ro duc t ion have fo c u s e d on computerized systems, it is the simpler analytical methods that have a high r isk of data integ- rity violations, because they are mandated in the pharmacopoe- ias, where they lack objective evi- dence of testing and an effective second person review. For example, in many labora- tories, the second person review of these tests merely checks if the manual observations have been recorded or calculated as required by the applicable procedure. In the case of classical pharmaco - p e i a l me t ho d s, s uc h a s L OD, specified in the monograph, the manual method outlined in USP <731> (16) has sig nif icant data integrity vulnerabilities. DATA INTEGRITY Some of the data integrity issues surrounding pharmacopeial test results that are based on captur- ing the observed result by manual recording are as follows: • What is the risk and impact of the test result? Many of these results are release tests, but what is the risk weighting of appearance compared with, for example, the impurity pro- file of an API or a potency test of the finished dosage form? Therefore, how much effort should be placed on ensuring the integrity of the result? • Visual acuity. For color tests, is color blindness testing for a l l a n a ly st s c onduc te d to Figure 3. The spectrum of pharmacopeial analytical procedures includes some methods with greater data integrity risk. UV is ultraviolet; IR is infrared; LIMS is laboratory information management system; ELN is electronic lab notebook; LES is lab execution system.