The and also covers process changes and challenges.

The Validation process in the Medtech industry is critical
to making both safe and effective medical products. This industry has seen a
lot of changes over the years especially in the field of Validations due to an
increased emphasis on applying a risk based approach to validation as well as
an increased importance on data integrity and Electronic records.  The main purpose of performing Validations is
to establish documented evidence that a process, equipment or method will consistently
fulfill particular requirements for a specific intended use. (21CFR 820). This
is completed by following the regulatory requirements, GxP requirements and
appropriate qualification tools. The most effective way to apply validation
practices in industry is by using a lifecycle approach to validations.

and Giodance Review

Prior to performing a validation of any nature it is
important to fully understand the validation requirements from a regulatory

There are three main Regulatory Standards that need to be followed
when completing validations; 21 CFR 820, ISO 13485:2016 and, if applicable, 21
CFR Part 11.

Code of Federal Regulations Part 820, (Quality System Regulation)

CFR Part 820 (Quality System Regulation) outlines quality
system and cGMP (Current Good Manufacturing Practices) regulations for medical
device manufacturers to ensure that the devices are safe and effective. The FDA
QS regulation is applicable to finished medical devices sold commercially in
the USA, including devices that are imported. (1). its’ intent is to define the
management of quality systems as it relates to the design manufacture packaging
and labeling a medical product. 21CFR 820 Subpart G (820.75) relates to initial
validation of a process followed by monitoring process performance after
validation and also covers process changes and challenges. 


In parallel with 21 CFR Part 820 a strong understanding of ISO 13485:2016 is also essential. It is
worth noting that ISO 13485:2016 is a voluntary standard for Quality Management
System of medical devices. However, it was recently updated (2016 from 2003) to
help users meet common regulatory requirements. Aligning with ISO has the
benefit of monitoring medical device safety and overall effectiveness. The
focal point of ISO 13485:2016 is risk management and risk based decision making
for most of the QMS process. (2) Greenlight guru

CFR Part 11

Part 11 applies to records in
electronic form that are created, modified, maintained, archived, retrieved, or
transmitted under any records requirements set forth in Agency regulations. (Guidance for Industry Part 11, Electronic Records; Electronic Signatures
—Scope and Application) Part 11 is specific to electronic records (Subpart B)
and electronic signatures (Subpart C). 21 CFR Part 11 must be applied to
validations with respect to audit trails, user access control and controls
around record retention.


5 – A Risk Based Approach to Compliant Computerized System



In a nutshell, GAMP®5: A Risk-Based Approach to Compliant
GxP Computerized Systems provides a framework for the risk-based approach to
computer system validation where a system is evaluated and assigned to a
predefined category based on its intended use and complexity. Categorizing the
system helps guide the writing of system documentation (including
specifications and test scripts and everything in between).