Validating your own Excel Spreadsheet Application is important
A key question many professionals face is: why should electronic records be validated? The answer is pretty straightforward: digitizing records is unavoidable, because organizations all over the world are moving towards electronic records and phasing paper records out. This has become a dire need because it is believed that it is high time the world moved away from paper records, both from the perspective of ecology conservation and speed. Digitizing paper records serves these two critical purposes.
Making records electronic is not optional
Electronic validation is the antidote to manipulation and forgery, which is one of the inherent risks of going electronic. If electronic records have to take the place of paper records and remain as effective and authentic; they have to be validated. That is why the FDA has made validation of electronic records in the pharmaceutical, biotech, medical device, CRO, life sciences or related FDA-regulated organization’s obligatory and compliant with its own regulatory section on this topic, 21 CFR Part 11.
A word about 21 CFR Part 11
21 CFR Part 11 is a set of FDA requirements which serves as the standard with which organizations have to be compliant. Being compliant with requirements set out in this code demonstrates that the electronic records used by organizations are genuine and are of the same standards as paper records.
Excel sheet application configuration is important
For this to happen, a key requirement is that an organization’s Excel spreadsheet application has to be configured. This has to be done to not only meet FDA requirements, but to also avoid 483’s.So, this means that an organization that does not meet 21 CFR Part 11 stands to face 483’s.
Major saver of time and resources
One of the key elements of implementing 21 CFR Part 11 is the requirement of configuring their Excel application with the features required for 21 CFR Part 11 compliance. When validation is done using appropriate and well-designed validation templates; an organization can not only avoid 483’s; it can save up to two-thirds of the validation time and costs.
What does compliance entail?
Implementation of regulations for electronic records needs knowledge of how to use and validate electronic records and signatures, which is what 21 CFR Part 11 is essentially all about. Taking a risk-based validation approachis a practical step, because of the simple fact that it reduces and sometimes even eliminates risks.
As for the Excel application themselves, the organization should have a methodology by which to create the following documentation into their Excel application:
o A User Requirements document
o A Project Plan document
o A Functional Specifications document
o A Hazard Analysis/Risk Assessment document
o A Testing Protocol document