GMP Data is Omnipresent now a days so Data Integrity is a key...
Data a longest lasting commodity for any company. Auditors favourite destination. If controlled best adds to Quality and Reputation of the firm.
It needs to be defined properly. Data Created Automatically or Manually. manual double check at creation of data most important.
Than it goes through life cycle of Saving, Review- Approved- Change with Audit Trail, Transmitting to server, Data Backup- Restoration, Archival – Retrival, Data Retention, Disaster Control, Business Continuity Planning, Data migration and Data retirement.
All stages are equally important.
Role based responsibility at all level helps with Device check and operational check. Data and system security is a must. All password security, System time out, System lock out as well as Eventlog check can give guidance to possible data integrity issues.
There are many more things to be considered for Complete SDLC stage like Incident management, CAPA, Change Control, Periodic Review of Validation and Audit Trail, Risk Based Assessment, complexity- Novelty of the system, Data Integrity SOP.
Excellent training to staff with crystal clear clarity of Why, What and by whom.
If we focus we get results. laser can cut the metal.
Written by: K R Vaghela
cGMP Data Integrity Official regulatory Guideline