Quality officers at organisations are tied up with reviewing and verifying quality of products and services and making sure that they meet the regulatory guidelines. There are multiple dynamic activities going on at each process and hence enforcing quality standards at every step becomes a challenge. Quality professionals should have a specification management to have a proactive position on quality incidents and ever-changing regulatory standards.
A specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which a new drug substance or new drug product should confirm to be considered acceptable for its intended use.
A typical specification management has the below benefits:
Create electronic forms as specifications and structure your data with controlled and verified values.
Streamline all versions of documents and distribute new versions to everyone. Minimize the risks of working from old versions and causing Out-Of-Specification (OOS)
Data security & integrity is a regulatory compliant requirement. Create hierarchy and user controls for security and choose control over who can do what and to which part of content.
Create and manage master specifications for Men, Material etc. This master data will not be editable at the user specification level.
Whenever documents and specifications become effective, an automated emailer is sent to respective users. Manufacturers are notified on critical documents when there is an issue during technical transfer between different platforms.
Coordinate with vendors in a controlled environment. Manage each specification to a particular vendor and give rights accordingly.
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