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IndustrialIT Solutions for the Life Sciences Industry 21 CFR Part 11: Electronic records and electronic signatures “Handwritten signature means the scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form.” 21 CFR Part 11 The Rule 21 CFR Part 11 For Life Sciences Industries, electronic signatures were given legal equivalence with traditional “wet ink” signatures on paper in 19
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  Industrial IT Solutions forthe Life Sciences Industry 21 CFR Part 11: Electronic recordsand electronic signatures  “Handwritten signature means the scripted nameor legal mark of an individual handwritten by thatindividual and executed or adopted with the presentintention to authenticate a writing in a permanent form.” 2 The Rule 21 CFR Part 11 2 For Life Sciences Industries, electronic signatureswere given legal equivalence with traditional “wet ink”signatures on paper in 1997.The Food and Drug Administration (FDA) rulefor electronic records and signatures became effectiveand enforceable on August 20, 1997. The rule has twomain areas of enforcement: electronic records andelectronic signatures.The rule applies to all areas of Title 21 of the Codeof Federal Regulation (CFR) for all manufactured drugsand medical products distributed in the United Statesof America.Detailed procedural and technical requirements aregiven for both electronic signatures and electronicrecords. Some of these include:  Ability to discern invalid records  Ability to generate electronic copies of records  Automatic generation of audit trail  Access controls  Secure link of signatures to records  Use of unique secure signaturesElectronic record keeping and electronic signature useare not mandatory, but if used must comply with therequirements of the rule.The scope of 21 CFR Part 11 includes operational areasof a pharmaceutical, biotechnology or medical devicecompany such as:  Manufacturing (for example, production records)  Maintenance (for example, asset management orcalibration records)  Laboratory (for example, sampling results orproduct development)Although this document deals exclusively with 21 CFRPart 11 for the U.S., many other jurisdictions also havedirectives in place that enable the use of electronicrecords and signatures. 21 CFR Part 11  3 You’ve been using electronicrecords for years “Electronic record means any combination of text, graphics,data, audio, pictorial, or other information representationin digital form that is created, modified, maintained, archived,retrieved, or distributed by a computer system.” 21 CFR Part 11 By the 1990’s technical ABB solutions existed forgenerating fully electronic batch records usingdistributed control systems. Batch management waseither handled by a separate software package or fullyintegrated with the DCS.This arrangement enabled a production plant tobe operated in accordance with the S88 standardor previous national standards, generating workingrecipes, monitoring inventories, controlling plantequipment and collecting all salient data under asecure access control arrangement.The DCS had a configurable report packagefor generating customized batch records andmanagement reports.At the same time, our batch software was becomingavailable for digital signing of records.The only item missing in the equation to make fullyelectronic batch records a possibility was the actualregulation.21 CFR Part 211.188 states “...records [must be]checked for accuracy, dated and signed.” Other clausesof Part 211 such as §186 refer explicitly to “fullsignature handwritten.” These were seen as regulatoryblocks on the pharmaceutical road to the digital world.Moving to fully electronic data handling promised hugecost savings from improved efficiency and reducedphysical handling and storage compared to traditionalpaper records, as well as increased security, traceabilityand transferability of data.It is not just in the manufacturing (GMP) area thatelectronic data handling offers noteworthy benefits.The amount of data generated in analytical laboratoriesoperation under GLP is significant, and since this datarequires review and approval signatures, 21 CFR Part11 promises major improvements in workflows anddata handling.  4 “Electronic signature means a computer data compilationof any symbol or series of symbols executed, adopted, orauthorized by an individual to be the legally bindingequivalent of the individual’s handwritten signature.” Our commitment Our customers ask for support moving into a paperlessworld in order to satisfy regulatory requirements aswell as business requirements such as ease of use andreduced costs. “Know the market, follow its demands,open up future opportunities for our customers.”This is ABB’s philosophy to create value for ourcustomers.21 CFR Part 11 has become an integrated part of ourautomation technology and system design. The rule isnot a “problem” anymore. We help our customers toachieve and maintain 21 CFR Part 11 compliancewhile minimizing life cycle costs. Regulatory compliance The Industrial IT automation system is a technologyplatform that can be installed and configured toconform to the 21 CFR Part 11 regulation.Our automation system complies with the rule’srequirements with features like system security, securedata management and reporting, electronic records andsignatures, and a time-stamped audit trail, forautomated electronic recording of changes. Electronic records and signatures Our technology combines the efficiency of electronicrecord keeping with the security of authenticatedelectronic signatures.Electronic records in an automation system are easierto keep than manual records. Records generated andmaintained by the automation system include:  Recipe and unit configurations  System configuration  Device calibration  Operator input  Audit trail  Alarm and event history  Trends and batch records  Shift, batch and other reportsThe system security protects electronic recordsfrom alterations by non-authorized persons.The automation system can ask the user toelectronically sign records; for example, when newcalibration data is released for download into aninstrument, a new batch recipe is approved forproduction or an operator input occurs. Theelectronic signature act is performed by user orsupervisor typing in their User ID and Password. 21 CFR Part 11

Quilling Catalog

Dec 31, 2017
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