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The Good News About 21 CFR Part 11Compliance Means Big Business Benefits - Again
While pharmaceutical manufacturing willalways have challenges that reach life safe-ty proportions, recent changes to FDA reg-ulations have improved the focus andresulting benefits related to batch recordkeeping. Specifically, the FDA rolled backthe policy and previous guidance onpaperless batch records and returned 21CFR Part 11 to its original intent - whichwas to provide a rule that allowed regulat-ed companies to use electronic records inlieu of paper records.
With the advances in manufacturingsoftware in combination with the new regulations, pharmaceutical manufacturershave a great opportunity - achieve produc-tivity gains and cost savings by using elec-tronic records and productivity technologyto meet requirements.
With the potential to save millions of dollars through improved manufacturingprocesses, pharmaceutical companies standto benefit from: • Increased ROI and improved ROA;• Improved quality control and process
control;• Reduced document management and
control by automatically preparing batchsheets;
• Decreased time to assemble completedbatch reports;
• Faster review and batch approval;• Less risk of regulatory compliance
issues;• Reduced life cycle costs of deploying,
validating and maintaining systems.To take advantage of these benefits,
pharmaceutical manufacturers need tounderstand the significant changes to 21CFR Part 11 and how to best execute tech-nology to meet the regulations and driveplant improvements.
Back on Track21 CFR Part 11 started with industry inputto the FDA on paperless batch records.When the rule became effective in 1997,Manufacturing IT suppliers started todesign software products that could deliverbusiness benefits while addressing 21 CFRPart 11 compliance. The goal was for “Offthe Shelf,” modular software to control theprocess automation, operator workflow and
digitization of data that met the regulatoryrequirements, and delivered business ben-efits. However, starting in 2000, the focusshifted to remediation of existing systems,delivering limited benefits for manufactur-ers, as increasing onerous interpretationand application of 21 CFR Part 11 occurred.With new guidance, the business benefit isback at center stage.
Some key points from the regulationsinclude:* Records that are required to be main-tained by predicate rules and that aremaintained in electronic format in place ofpaper format.Reduces the scope of what constitutes an e-record,no longer being applied against electronic records of systems used to produce paper records* The Agency intends to exercise enforce-ment discretion regarding specific Part 11requirements for validation of computer-ized systems.No additional validation requirements• The Agency intends to exercise enforce-
ment discretion regarding specific Part11 requirements related to computer-generated, time-stamped audit trails...Audit trails can be par-ticularly appropriatewhen users are expectedto create, modify, ordelete regulated recordsduring normal operation.
Reduced requirements for audittrails, but still needed forrecords created during normaloperation• The Agency intends to
exercise enforcementdiscretion with regard tolegacy systems that oth-erwise were operationalprior to August 20, 1997.
Reduces requirements forurgent remediation of legacysystems• The Agency intends to
exercise enforcement discretion withregard to specific Part 11 requirementsfor generating copies of records.
Can supply records in source form, or a commonexchange format• FDA normally does not intend to object
if you decide to archive required recordsin electronic format to non-electronicmedia
Allows e-records to be moved to more permanentstorage media once the benefits of electronic storagehave been gained
These changes to 21 CFR Part 11 allow ameaningful choice between paper and elec-tronic record storage based on the businessbenefits and return on investment. They donot dilute the security and integrity of elec-tronic record keeping. They simplify themaintenance of e-records and make it morepractical to implement through manufac-turing software technology.
The Take on TechnologyManufacturing software helps pharmaceu-tical companies achieve 21 CFR Part 11compliance through: centralized passwordand user management, point verification,centralized storage of e-records and audittrails, and simplest remediation of existingsystems.
Advanced manufacturing software has the potential tosave pharmaceutical companies millions of dollarsthrough improved processes.
Point verification: The electronic signatureshould be captured at the point of writingthe record, and applies to both e-Signatures and authority checks. On theplant floor, changes are made in real-time,i.e. change the set point in the controller,so all signatures must be collected togeth-er ... no undo! Additionally, continuoususe does not allow for simply acquiringthe current logged on user name. A criticalaspect is to have the meaning associatedwith the signature, ie what am I changingfrom-to.
Centralized storage of records: Plant floor sys-tems are distributed in nature, and cen-tralized storage of records simplifies man-agement, duplication and security ofrecords. Record stores must implementsecurity that verifies identity, authorizesaccess and stores audit trial. Securityshould be implemented at the server levelfor manageability and confidence, andshould imply some level of physical secu-rity for servers. The two types of data -time based and record based - require twotypes of stores.
Automatic generation of the audit trail: Theregulations do not require automatic gen-eration of an audit trail unless the userwill routinely be entering and changing thedata - which means it is needed on theshop floor. Companies need to understandthe audit trail, in terms of the record. For
example, changing a set point in a con-troller should create an audit trail in thebatch record. Audit trail generation shouldbe automatic and unalterable, and the sys-tem should also audit actions on the audittrail (i.e. audit trail was stopped, restarted,etc.). Lastly, an audit trail requires anidentity check and an authority check ofthe user, which must be included in theaudit trail.
Storage of audit trail with the record: Theaudit trail is an integral part of the record,and separating the two into different areasreduces confidence in the audit trail.Companies need to maintain audit trailinformation on the same record retentioncycle and determine how to audit actionstaken on the audit trail.
Simple remediation of legacy systems: Legacysystem remediation is a major issue forplant floor systems. Remediation shouldminimize the impact on validation andshould be achieved through either newversions with improved features or prod-ucts that can overlay existing applicationswithout changing them. A remediationplan should include formal commitmentsfrom technology suppliers.
In summary, the recent changes to 21CFR Part 11 are good news for pharmaceuti-cal manufacturing companies. The opportu-nity to achieve both compliance and busi-
ness benefits is clearly viable and throughthe same overall technology solution. And,achieving compliance is no longer about abusiness cost - instead it is about an invest-ment with a fast return through improvedmanufacturing productivity.
— By Bob Honor and Steve Pulsifer, Life Sciences Management, GE FanucAutomation
About the AuthorsBob Honor currently serves as the GE
Life Sciences Business Leader and StevePulsifer as the GE Life Sciences MarketDevelopment Manager. GE Life Sciencesis chartered with providing solutions tai-lored to the unique needs of the regulatedindustries including pharmaceutical, med-ical and healthcare. These solutions seekto improve the industries' operationswhile meeting FDA regulations. Honor has20 years' experience in the automationindustry, having worked in engineering,marketing and sales, and providing bothdiscrete and process automation solu-tions. Pulsifer has more than 20 years'experience in Manufacturing IT Solutions,having worked in manufacturing, quality,sales and marketing. Both have been withGE Fanuc Automation since 1999 and canbe reached at [email protected] [email protected].
Delavau in Philadaphia, Pa., moved from recordingall batch data by hand and storing on paper to electronic data collection, analysis and storage.
With an easy-to-use electronic data collection, analysisand storage system, operators can make a smooth, fast transition from traditional manual data collection.
Top 10 for Part 11: Key Technology CriteriaManufacturing software helps pharmaceutical companies achieve 21 CFR Part 11 compliance, butthe software by itself cannot be considered “compliant.” Pharmaceutical companies often approachsoftware companies with the question, “Is your software compliant?” However, the FDA does not visita software company and label its product 21 CFR Part 11 compliant. Applications, not software,must be validated in order to be 21 CFR11 compliant. The bottom line is that software ships in a boxand is configured to meet the requirements and specifications of the application. Therefore, compli-ance is determined by the combination of the technology, the implementer, and end user.
Separately, having technology “designed for 21 CFR 11” functionality is a critical element to thesuccess of the project. It means the foundation on which you build your manufacturing automationsolution is appropriate for the task. The converse can be true: software can certainly be deemed non-compliant if it does not support features as basic as security password expiration and aging. Look for technology that meets the following top 10 for Part 11 criteria:1. Built-in 21 CFR Part 11 functionality2. Point verification3. Comprehensive user activity audit trail4. Electronic signatures across all software packages5. Multiple electronic signatures per I/O point6. Tools to retrieve audit trail records7. Electronic signature capture for alarms8. Synchronized access to plant floor and business security9. Security by user and location10. Services, training and consulting support
Reprinted with permission from Pharmaceutical Processing
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