000			02815cam a2200409Mi 4500
001			on1305845639
003			OCoLC
005			20240726104850.0
008			220319s2022 nyu o 000 0 eng d
040			_aEBLCP _beng _erda _cEBLCP _dNT
020			_a9781685077266 _q((electronic)l(electronic)ctronic)
050	0	4	_aRM301 _b.E743 2022
049			_aMAIN
100	1		_aLópez, Orlando, _e1
245	1	0	_aE-records integrity requirements /Orlando López.
246	3		_aRequirements of e-Records Integrity
260			_aNew York : _bNova Science Publishers, _c(c)2022.
300			_a1 online resource (330 pages).
336			_atext _btxt _2rdacontent
337			_acomputer _bc _2rdamedia
338			_aonline resource _bcr _2rdacarrier
347			_adata file _2rda
490	1		_aResearch methodology and data analysis
504			_a2
520	0		_a"The worldwide medicines' manufacturing practices regulations depend heavily on reliable data and records. The information properly recorded is the basis for manufacturers to assure the regulatory authorities of product identity, strengths, purity, and safety. The collected electronic records (e-records) also demonstrate that the manufacturing process adheres to the CGMP, including instructions. An element of reliable records is the integrity of such records. For the relevant stakeholders, such unauthorized alterations will be catalogued that the system is without the proper data integrity (DI) controls and would be deemed a noticeable deficiency. As a state or condition, e-records integrity is a measure of the validity and fidelity of related data. Based on the Universal Electronic Records Management (ERM) Requirements, Version 2.03 published by the National Archives and Records Administration (NARA), this book covers the requirements applicable to DI in the medicines' manufacturing practices regulations, pharmaceutical and biotechnological. This book presents the bounded characterization of e-records handling systems. The reader will have a reference of over fifty-three requirements that need to be agreed upon between the relevant stakeholders."-- _cProvided by publisher
530			_a2 _ub
650		0	_aPharmaceutical industry _xStandards.
650		0	_aDrug development _xStandards.
650		0	_aElectronic records.
650		0	_aInformation storage and retrieval systems _xMedicine.
650		0	_aInformation storage and retrieval systems _xPharmacology.
655		1	_aElectronic Books.
856	4	0	_zClick to access digital title | log in using your CIU ID number and my.ciu.edu password. _uhttpss://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=3186404&site=eds-live&custid=s3260518
942			_cOB _D _eEB _hRM. _m2022 _QOL _R _x _8NFIC _2LOC
994			_a92 _bNT
999			_c80983 _d80983
902			_a1 _bCynthia Snell _c1 _dCynthia Snell