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The purpose of document change control systems is to ensure that manufacturers build products that are safe and reliable.  Good Manufacturing Processes (GMP) presume that both the process and documentation directing the process follow pre-approved methods, and any change to these methods is both restricted to authorized personnel, and tracked for future review.  All FDA-regulated companies are mandated to have a document change control system.

Inefficient document control systems costs FDA-regulated manufacturers millions of dollars, mainly attributed to the inefficiencies that occur when using a paper/hybrid-electronic system.  (Whereby document change control is managed in an un-automated, manual fashion, using a combination of both paper and electronic files.)   These manual, labor-intensive systems are proven to be error-prone, delay time to market, and introduce product quality problems that can risk stringent regulatory penalties.  The FDA cites inadequate change management as a major cause for “Form 483” observations.   Example shortcomings include documents missing dates or numbering schemes, uncontrolled copies floating around the company and document changes without approvals or explanations.  To eliminate these inadequacies, regulated companies are turning to the use of electronic-based quality management systems.

Today’s quality management systems provide integrated solutions to handle everything from corrective /preventive actions (CAPA) through change control and training. This article will focus on change management within the quality system lifecycle and provides insight as to the capabilities needed to automate change control processes to help increase efficiency, ensure compliance with FDA requirements and improve profitability.

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Figure 1 – Change control as part of the quality management lifecycle

OVERVIEW

To eliminate the problems FDA-regulated companies are being cited for during inspections and audits, a change management / change control software must incorporate the following capabilities:

§          Compliance Management

§          Document Management

§          Revision Control

§          Intuitive System Administration Tools

§          General Users/Viewer Usability

§          Open Architecture

§          Complete Implementation and Validation Tools

COMPLIANCE MANAGEMENT

In order to move from a manual, paper-based system to an electronic, automated system, manufacturers must follow the guidelines outlined in regulation 21 CFR Part 11 for using electronic records and signatures including:

§          Multi-password access and signature…forced expiration – The FDA requires two distinct identification components for document compliant change control – one for login and one for document approval. Options should be available for configuring the length of the password and alphanumeric combinations to maintain the highest levels of security for the system.  Password expiration, encryption and certification are also necessary.

§          Account and intruder lockout – An account should be automatically locked for both login and approval anytime a password or login is compromised.  If any unauthorized attempt is made during either login or approval, the intruder lockout feature activates after the number of unauthorized login attempts or approval attempts has been reached.  The number of attempts should customizable as set by the system administrator.

§          Signature manifestation on the document – Signature manifestations are required for FDA regulated companies to meet Part 11 requirements and should be automatically appended to each document including first name, last name, date, time and meaning of the electronic signature.  Manifestations should appear on all human-readable forms that are either viewed electronically on the computer or printed on paper. 

§          Change control rational – Changes made to document metadata should be tracked. (The Metadata contains document attributes like title, author, etc.) Each time a change is made to any metadata, a user must enter a reason for the change. The system must track each of these changes and make them available for review.

DOCUMENT MANAGEMENT

Document management capabilities boost efficiency and ensure compliance by eliminating labor-intensive tasks like physically routing documents for approval, storage and distribution.

§          Format Agnostic – The system must be able to control any document regardless of the application used to create.  (Word processing, spreadsheets, CAD, video, audio…)

§          Document lifecycle management – Documents must be managed through their lifecycle statuses of Draft, Released and Archived. (See Figure 2)  Lifecycles can be based on document type and need to automatically adjust document security based on lifecycle status.

§          Audit trail history / record archiving – A secure, time-stamped audit trail of all changes made to any record should be maintained and accessible to the appropriate users and departments. All of this information needs to be automatically captured and secured.  Reporting functionality would track past versions, metadata and approval history of the record, from the time it was created until the present.

§          Centralized, Secure Repository – Documents should be securely stored to insure only authorized access, while making it easy to protect against disaster.  

§          Document cross-linking – In manufacturing environments, documents complement one another.  For example, a form may be associated to a standard operating procedure (SOP), or an equipment manual associated with a maintenance drawing, etc.  A document control system should allow document linking to provide users the relevant information needed to do their job.

REVISION CONTROL AUTOMATION

Document revision control represents one of the biggest time consuming tasks that is most ripe for automation.

§          Ensure control of all document versions/revisions – Be able to present the currently released document, while simultaneously managing collaborative changes that will result in a new revision.   

§          Control Rogue Documents – A system should alleviate the consequences of uncontrolled electronic documents by enabling copies to “Self Destruct” after the “configurable” time allotted to the document expires. For example, a document that is saved outside the system and e-mailed to another person would be impossible to open 48-hours after it is copied from the system. Similarly, a system should offer capabilities to manage printed documents.  Anytime a document is printed from the system, expiration dates and times should be automatically watermarked prominently on the document. 

§          Automate document routing, approval and escalations – Document routing and approvals should be automated to notify all approvers or collaborators in the authorization chain.  Configurable, time-based escalation features can expedite approval and collaboration cycles in case users are too slow to act or are unavailable.  Upon approval, old versions would automatically revision while users affected by the change are assigned a task be trained or re-trained. (Training is addressed in a supplementary white paper available from DCS)

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