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JUL-AUG 2017

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30 INTECH JULY/AUGUST 2017 WWW.ISA.ORG AUTOMATION IT Contemporaneous Contemporaneous means to record the result, measure- ment, or data at the time the work is performed. Date and time stamps should flow in order of execution for the data to be credible. Data should never be backdated. For example: l If executing a validation protocol, perform tests and record their results as they happen on the approved protocol. Con - sider calibrating an instrument 35-feet up above in the fac- tory. I have the technology sign that record at that particular moment. The moment I created the record of that informa - tion on a sticky note, paper notebook, or other place, I have created a primary record, which the regulators are interested in. Data that is logged, or testing that is performed electroni - cally, should have a date/time stamp attached to the record. l Make sure electronic systems that log data have synchro- nized system clocks. l Consider using a master clock system that synchronizes to the IT network, so wall clocks within labs and processing areas are synchronized. As an industry, these are challenges we need to spend more time thinking about—how we manage raw data and meta- data, and efficiently capture it into computer systems. Original Original data, sometimes referred to as source data or prima- ry data, is the medium in which the data point is recorded for the first time. This could be a database, an approved protocol or form, or a dedicated notebook. It is important to under- stand where your original data will be generated, so that its content and meaning are preserved. For example: l Ensure validation test results are recorded on the approved protocol. Recording results in a notebook for transcription later can introduce errors. l If your original data is handwritten and needs to be stored electronically, make sure a "true copy" is generated, the copy is verified for completeness, and then it is migrated into the electronic system. Accurate For data and records to be accurate, they should be error free, complete, truthful, and reflective of the observation. Editing should not be performed without documenting and anno- tating the amendments. For example: l Use a witness check for critical record collection to con- firm data accuracy. l Consider how to capture data electronically and verify its accuracy. Build accuracy checks into the design of the electronic system. l Place controls and verification on manual data entry; for example, temperature results can only be entered within a predefined range of 0–100°C. Common issues Here are a couple of common examples where ALCOA is not followed, resulting in poor documentation and data integrity issues: l Frequently, data is quickly jotted down on a sticky note or on a notepad during testing. This data is then transferred to the approved protocol or form. Doing this, whether for lab results or a validation exercise, means the data is no longer original or contemporaneous, and it is potentially inaccurate. l When making a correction to information, it is common to see the old data scribbled out, overwritten, or removed using correction fluid and sometimes without an initial and date of who made the correction. This means the data is no longer legible or original, and the correction is not attributable. The most efficient approach is to catch deviations and problems to mitigate the root causes and eliminate the problem permanently. This is easy to state, but sometimes quite challenging to accomplish, particularly with the com - plexity around some products. Information protection Information protection is a growing concern with more at- tacks on systems, requiring many good controls to be in place. It only takes one email and one click to compromise the system. If the system is compromised, will this also compromise the data? If it does compromise the data, will people know? All these programs have to operate in harmony. Ideally, Attributable Who acquired the data or performed an action and when? Legible Can data be read? Contemporaneous (real time) Is the data documented at the time of the activity? Original Is data recorded from an original observation or a certified copy? Accurate Is the information complete, consistent, and correct? Complete All data is included (e.g., testing, repeat, or reanalysis) Consistent Consistent generation of records and application of time stamps Enduring Data recorded on controlled worksheet or in validated systems Available Data available for review, audit, inspection for the life of the record

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