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Table 1 Typical Data Integrity Compliance Table 2 Innovative Data Integrity Compliance
Chromatography Spectroscopy *1 Chromatography and Spectroscopy
(Data Acquisition and Management) (Data Management) (Data Acquisition) (Data Acquisition and Management)
Acquisition Yes — Yes Acquisition Yes
Data Data
Management Yes Yes * 2 — Innovation Management Yes
Audit Trail (Metadata) Yes — Yes * 2 Audit Trail (Metadata) Yes * 4
Users Yes Yes * 3 Yes * 3 Users Yes
Security Yes Yes Yes Security Yes
Time (Time Stamp) Yes Time (Time Stamp) Yes
• Requires two servers, one for chromatography and one for spectroscopy.
• Requires three types of software: (1) For chromatography data acquisition and management • One server
Remarks (2) For spectroscopy data management Remarks • One software program * 5
(3) For spectroscopy data acquisition • Compatible with electronic data
• Not compatible with electronic data
*1: This table is based on a case of using a data management system to manage spectroscopy data that differs from the brand of the spectroscopy system. *4: Spectroscopy data and audit trail data can be reviewed and managed in a unified manner.
*2: In this example, spectroscopy data and audit trail data cannot be reviewed and managed in a unified manner. LC GC UV FT-IR RF *5: In this case, "one software program" means all the elements indicated in Fig. 1 can be managed
*3: In this example, users that acquire spectroscopy data cannot be managed in the same manner as users that manage spectroscopy data. in a unified manner.

ning Letters
ar
2. FDA W
4. Obstacles for Ensuring Data
6. Procedure for Using LabSolutions
2. FDA Warning Letters 4. Obstacles for Ensuring Data Due to the current attention on data integrity, focus has shifted 6. Procedure for Using LabSolutions
Integrity Compliance for
to Create a Report Set for
Integrity Compliance for toward providing evidence to reviewers that no improper opera- to Create a Report Set for
The FDA website includes several examples of warning letters for tions were performed with respect to analytical results. However,
Spectroscopy Systems:
Spectroscopy Systems
spectroscopy systems that show how warning letters are now being Spectroscopy Systems: this approach represents a policy of punishing any practice that ap- Spectroscopy Systems
Audit Trail and User Management
issued specifically for UV and IR systems. (See below.) Audit Trail and User Management The procedure for creating a report set for spectroscopy systems cor-
pears suspicious, which is a major departure from the approach
As illustrated in Fig. 1, compliance is based on Good Manufactur- responds to the procedure for chromatography systems, so the report
used in previous investigations. This approach applies to both
8)
• Warning Letter—Example (1) 6) ing Practice (GMP), which is premised on the validation of systems chromatography and spectroscopy systems, which means the con- set can be created using the same simple operations for both types of
and analytical methods. Furthermore, data, audit trail (metadata), systems. As shown in Fig. 2, the procedure steps are (1) select the de-
In response to this letter, provide details of your retrospective ventional approach cannot be used to ensure appropriate compli-
and user operations must be correctly time-stamped in a secure sired files, (2) right-click on the files and click [Create Report Set] on
review of the HPLC and other laboratory data, such as Fourier trans- ance.
environment. If a laboratory has both chromatography and spec- the right-click menu, and (3) complete the report set. Completed
form infrared spectroscopy, gas chromatography, UV spectropho-
troscopy systems, the elements shown in Fig. 1 apply to both chro- 5. Innovative Data Integrity report sets are automatically stored in a database to prevent replac-
5. Innovative Data Integrity
tometry, and (b)(4) analyzer data.
Compliance
matography and spectroscopy systems, such that compliance with Compliance ing, altering, destroying, or otherwise tampering with the data.
data integrity requirements results in the complicated operations When a report set is created, it generates an electronic link between
• Warning Letter—Example (2) 7) indicated in Table 1. Therefore, considering that data integrity compliance for spectros-
copy systems could present a major obstacle for operating analytical the electronic data and the report set, which also automatically dis-
You lacked controls to prevent the unauthorized manipulation of Typical systems retain audit trail data (metadata) within the spec- laboratories in a regulated environment, there is a need for an inno- ables (locks) editing the electronic data. That means editing or oth-
your laboratory’s electronic raw data. Specifically, your infrared (IR) troscopy data acquisition system as indicated in Table 1, but cannot vative approach to ensuring data integrity that solves such prob- erwise tampering with electronic data can be prevented after re-
spectrometer did not have access controls to prevent deletion or al- manage spectroscopy and audit trail data in a unified manner. lems. That is exactly what LabSolutions achieves. ports are created.
teration of raw data. (That means the data cannot be managed in a linked state.) The
LabSolutions takes full advantage of Shimadzu's unique position as In this case, electronic signatures can be used not only for review-
same applies to the user management. Typical systems cannot ing and approving report sets, but also for reviewing and approv-
3. Data Integrity Compliance for
3. Data Integrity Compliance for manage data management users and data acquisition users in a a developer and manufacturer of a wide variety of analytical instru- ing the electronic data (analytical results) on which report sets are
oscopy Systems
Spectroscopy Systems unified manner. ments. Therefore, Shimadzu is able to offer a unique solution for
Spectr
data integrity compliance that is not limited to chromatography sys- based. Using electronic signatures also eliminates the need to
So, what sort of compliance is required for ensuring the integrity of GMP tems, but can also comprehensively include UV and IR systems and print out and sign reports manually and enables a paperless opera-
data from spectroscopy systems? other spectroscopy systems in the LabSolutions family. (See Table tion, which eliminates the need for redundant management of
In terms of the form of the data, spectroscopy data are considered Data 2.) both electronic and paper records. That also solves the problems
dynamic data, as indicated in the FDA and WHO excerpts on the Security In other words, Shimadzu successfully integrated operations for en- associated with paper records, such as replacement, alteration, or
previous page, just like it is for chromatography data. Therefore, Audit trail Time suring data integrity by deploying the LabSolutions Report Set func- disposal of records.
presumably a key point for compliance will be ensuring equivalence stamp tion , which received excellent reviews for ensuring compliance Additionally, as shown in Fig. 2, data lines are color-coded when
9)
Users
with chromatography systems. with data integrity requirements for chromatography systems, for electronically approved, so they can be easily differentiated from re-
maining data that has not been reviewed or approved. That ensures
use in ensuring data integrity compliance for spectroscopy systems.
SOP A key feature of the report set is that it includes all the information orphan data can be identified easily, just as it can be for chromatog-
raphy systems.
Validation necessary for validating data integrity, as shown in Fig. 2, step (3)
Complete a set of reports.
Fig. 1 Illustration of Data Integrity Compliance
2 3