| FDA 21 CFR Part
II |
Regulation from the US Food and Drug Administration covering the storage of data involved as part of the drug development cycle. Requires access control, tamper-evidence and other requirements regarding the data integrity. |
Document storage
Database
Access Control and Security
Storage
Processing Power
Backup
Disaster Recovery |
Operational
The use of electronic record keeping is not mandated, although where electronic records are used, they must comply. |
|
Sarbanes-Oxley Act (SOX) |
Act (part of 2002, Sarbanes-Oxley Act) which
mandates that all auditing firms retain
records relevant to audits and reviews
also has significant implications on
companies’ IT resources. |
Document
Retention Systems
Email Management Systems
Content Management Storage Solutions |
Operational
SOX 404 deadline for non-accelerated filers and foreign private issuers in 2007 opening IT solutions for automated reporting including US owned off-shore corporations. |
| FDA Drug Barcode Regulation |
New
regulation from the US Food and Drug
Administration has been introduced which
mandates that all drug companies put bar
codes on all drugs dispensed in
hospitals and some retail pharmacies. |
Supply
Chain Technology
Database Solutions
Wireless Technology
Hardware (e.g. scanners) |
Potential
Investment is planned to begin much sooner than the expected 2006 deadline. Given spend will often be necessary in a number of technology solution areas, early preparation is crucial. |
| FDA
Combating Counterfeit Drugs Initiative US |
The FDA is keen to see the adoption of RFID technologies to help combat a rise in counterfeit drugs. The use of RFID
will help track drug batches. |
RFID Technologies and Tags
Networking
Storage |
Potential
The FDA has lifted some of the regulations on labelling until 2007 to make implementation feasible. |
| Good Laboratory Practice (GLP) |
A mixture of external best-practice standards and internal policies that combine to form the basis of all work carried out in the laboratory. From this standard operating procedures are developed that are followed by all lab bench workers. GLP
may contain the need to record
information in a 21CFR Part 11 compliant
system. |
Laboratory
Information Management Systems (LIMS), storage, networking, electronic signature, security, database. |
Operational
GLP forms the basis for laboratory practice. Adherence to GLP is essential to validate the integrity of
lab work carried out and therefore that the results can be trusted. |
| Good
Manufacturing Practice (GMP) and Good
Automated Manufacturing Practice (GAMP) |
Adherence
to GxP for manufacturing is heavily
regulated and controls the quality of the final product. Achieving compliance is necessary before any drug
manufactured can obtain a license for
distribution. |
All
areas of the manufacturing product line,
networking, specialist chemical
engineering systems, labelling systems,
packaging equipment. |
Operational
Continual adherence to GMP and GAMP are essential to pharmaceutical companies. Care needs to be taken when introducing new systems that these compliance requirements are not broken. |
| Good Clinical Practice (GCP) |
GCP lays
down the regulations for carrying out
four-stage clinical trials. Requires the
tracking of participants in the trials,
safeguards of anonymity and security of
data amongst other. |
Storage
Database
Security
Anonymity
Workflow
Specialist Systems |
Operational
Needs constant monitoring to ensure that each new trial is compliant. |
