Managing the Validation of Custom Databases

Written by Frederick Sperry - Validation Manager, QPharma

The management of custom databases does not need to be an onerous task.  When taken seriously, one can justify the management of the details associated with the database as Good Business Practices.  Even the elephant can be eaten – one bite at a time. 

Initially, as in any other activity in the regulated industry, know your process.  Identify the key parameters that user requirements have defined for the database.  What are the macros supposed to be doing, or any critical connections or formulas expected to produce?  Document the findings as an initial deployment of the system, and get a system user review and approval of the requirements for the database.

Validate your process.  Document the settings and verify the any formulas, macros of interfaces do what they are supposed to accomplish.  Adjust any settings that do not meet the needs of the end users.  Then update your documentation, and get review and approval signatures of the documentation.  Typically this is in the form of a System Design Specification, System Configuration or Functional Specification document.  The title of the document is not important; the current information is the critical item.

After the ‘deployment’ of the database keep the documentation current.  The database configuration and settings are liable to change over the course of normal system usage.  Keep track of the changes and periodically update the system documentation, and obtain the crucial user or management review, approval and sign off of the updated system settings.

Keep current with the data and database and embrace the new era paradigm shift from documentation to information.  The documentation must empower the system users to be able to use the information as knowledge.  In this new millennia day and age of information, knowledge is truly power.

Understanding both Electronic and Handwritten Signatures within the Context of Part 11

Written by Robert Finamore - Director, Validation Services, QPharma

21 CFR Part 11; Electronic Records, Electronic Signatures defines the FDA’s requirements for using records and signatures in electronic form to meet the record-keeping requirements of Agency regulations.  In more than ten years dealing with Part 11 compliance, I have often seen confusion over exactly what constitutes an “Electronic Signature.”  The title of the regulation itself uses the term “Electronic Signature,” which is somewhat of a misnomer since the regulation deals with several different types of signatures that are used in electronic form.  The different types of signatures include standard electronic signatures, digital signatures, and handwritten signatures captured electronically.

Electronic Signatures (“e-sigs”) are the types of signatures most people think of when considering Part 11.  Electronic Signatures are defined as “a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.”  This indicates that some information must be entered electronically and associated to a record for that record to be considered signed.  There are two standard types of e-sigs: Biometric and Non-Biometric signatures.

Biometric Electronic Signatures involve “a method of verifying an individual's identity based on measurement of the individual's physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable.”  This unique measurement must be captured every time a record is signed and such measurement would need to be securely linked to the signed record.  Examples of biometric signatures included fingerprint scans or iris scans.  This type of signature requires some type of measurement hardware attached to the computerized systems for the signature to be executed so it has not currently seen widespread use in the life science industries.  Biometric Signatures must comply with both the General Signature Requirements and Electronic Signature Requirements as defined in §11.50, §11.70, §11.100, and §11.200(b) of the regulation.

The other type of standard e-sig is the Non-Biometric Signature.  This type of signature requires entry of two or more distinct signature components into the computerized system as the e-sig execution action.  The traditional e-sig requires entry of a User ID and. . .