0688 MICRO LABS LIMITED, BANGALORE 3 zz secveDate [oe 6 QUALITY ASSURANCE PROCEDURE : Next Reviow Date: oie ‘Supersedes No: :MILCM:084 Title: | HANDLING AND CONTROL OF DATA INTEGRITY 1.0 PURPOSE: “This proceduce eneures that all manual and electronic data generated during the GMP processes and implemented through quality management system Is complete, consistent and accurate throughout the product Mecycle and in compliance with applicable reguleions. This procedure ‘emphasizes that everyone in the company is responsible for data integy. 20 SCOPE: ‘The procedure includes reporting and investigation of breach of data Integy and training and education of employees for ongoing compliance wih the requirements of data integtiy. This procedure is appicable to all manufacturing sites and Research & Development centers of Micro {Cabs Limited. 30 RESPONSIBILITY: 24 Head-Corporate Quality Assurance: To establish policies and procedues. pertaining to dala J°" jntegniye ensure the. appropriate resources to monfor and maintain the policies, assist in investigations when a volaion s reported 32 Manager Corporate Quality Assurance (CQA): To ensure the traning of Corporate Quality ‘Assurance employees on data inlegiy, 10 oversee the compliance program and / or the Investigation process when 2 vieation is reported in Corporate Qualty Assurance department 3.3 Head-Quality Assurance: To ensure the training of employees on data inogtty; to oversee the ‘compliance program andor the investigation process when a vilation is reprte. 34 Head - Development Quality Assurance (DA): To ensure the training of R&D employees on ata integrity, o oversee the compliance program and I or the investigation process when Violation is reported, 3.5 Department Heads: To ensure the inlegriy of data generated in the department; to support the ‘employees wio raise conceme on data integrity. to ait in departmental aust. janatorea [Name | Designation | Signature Date Prepare by | ORexts! E|oy rorege| — GaseUl Oefoe lie [checked by | chakrle ¢ fet | cen coal a lor/orfic [Approved by (Cy. f4Sibnen/| Sr-vP— (oa) = nfoG he [Department: Corporate Quality Assurance | Dato of issuo: \2]e8hé | Page tof 13, [Effective Dato at Site: | JeqliG ‘GAP MLCME OOS FSDIRwot M_Copy No. OF vy ALE ta tehole = MICRO LABS LIMITED, BANGALORE _|No: QAP-MLCNLOS4IA QUALITY ASSURANCE PROCEDURE effective Date: 3/0/16 [Supersedes No: Title: | HANDLING AND CONTROL OF DATA INTEGRITY 3.7 All Employees with GMP Responsibilities: Responsible for understanding and achering to all the ‘egulatons and policies applicable to their rola; signed acknowiedgement of the poicy as a Conaiton of continued employment. 4.0 DEFINITION: J41 Data: Information derived or obtained from Raw data (e.g. a reported analytical result). The data shall mee! the ALCOA requirements in which the Data must be: ‘A= Atbutable othe person generating the deta {Lege and permanent = Gontomeraneous © Orginal (or "bue copy) Bo accurate 4.2 Raw data: Original records and documentation, retained inthe format in which they were orginal | ‘generated (ie. paper or electric), or a8 a tte copy”. Raw data must bo cantemporaneously and Sceuralely recorded by permanent means. Inthe cate of basi electronic equpment which does not Store eletronie data, or provides only a printed data output (eg. balance or 3H meter), the piniout ‘constitutes the raw data, Raw data must: + Be legible and accessibe throughout the data ifecycte. 1 Permit the fll reconstruction of the activities resuiting inthe generation of ne data 43° Primary Record: The record which takes primacy in cases where data collected or retained| ‘concurrently by more than ane method fal © concur. In situations where the same information is recorded concurrently by more than one system, the data owner shall define which system generates and retains the primay record, in case of ‘screpancy. The primary record’ attbute shall be defined in the qualy syst, and shal nt be ‘changed on a case by cave basis, Signatories | Name | Designation | Signature | Date Propared by rest ee [by Hones Med | axfoalic checked by | halite $f: |e aom eqn) SG | %, he fe | Deparment Corporate Gualy Assurance [Date oflooue: aballé | Page 2 of Effective Date at Site: j=1JealIG eel ‘GAPMLCMOORFIRER COPY Lt Copy Wo: 05 sey, AB pa COE MICRO LABS LIMITED, BANGALORE Ino: QAP:MILCM:O64/A QUALITY ASSURANCE PROCEDURE — |efective Date: ¢/02[I6 45 46 a7 50 sa 5A [Supersedes No: HANDLING AND CONTROL OF DATA INTEGRITY |QAP:MLCM:064 Dated: 05/045 Data Integy? Generating, vaneforming, maintaining and assuring the accuracy, completeness | ‘and consistency of data over ts entre if cycle in compliance wth the appiceble regulations. Breach of Data Integrity: Acts of falsification, document adulteration, forgery and providing mmsieading information, intentional misrepresentation of data to hide known orpotental problems ‘Audit Trait: GMP audit traits are metadata that are a record of GMP citicalormation (for example the change or deletion of GMP relevant dat). Metadata: Metadata Is data that describe the attributes of other data, and provide context and meaning. Typical, these are data that describe the structure, data elements, intr relationships and ‘ther cnaraterietis of data, I also permits data to be afiibutabe fo an inaviual PROCEDURE: Data Integrity Policy 1 The company’s approach to data nog, ovr objective and recto of he company related to dua ugity mates frmaly dscrbed nthe Data inte Poy’ that Fas been authorized By the Drector of he company. 2. The content of Data reat Poy provided in “Annexure UA. The Corporate Guay Assurance ‘iar debute the pay copy of outhoraed Dat lntegrty Poy to Qualy surance deparment Far manctocung Stes and 6A deparment of REO. The Quay Assurance shal ditt the Style to oharSapatmens fo playing in eoch ea of th oct fr he bene c employees. The key atibts of data qualiynacessary fr assuring te intgiy ofthe deta are commonly ‘eleted ip as ALCOA an are desorbed below ( Rbuabie” | Who aire he dala or pared an ation and when?” | [Leste | Can you read he deta and any logbook enties? Goriemparaneousi | Document athe time of he acy ‘Ofsinal Wikten prot or observation oa ceed eapytoeot [Acerate: TN errors or editing without documented amendments. Signatories [Name Designation | Signature [ ate ch Prepare y osfoel parody [Shatl & [Dy.Marogs) atl |osfoclic Checked ty |Ralitle SA lara con | GB - cause [Departments Corporate Guality Assurance | Date ofissue: IAlsé/é | Page dof 13 | Effective Date at Site: j-7 109/16 ~GAPHILEM OOS FTA