CPSA Digest 2003

Day 3

WeOA3

Impact on High Volume Bioanalysis in a Contract Research Environment
Part 11 Guidance

Background
In 1997, FDA issued final part 11 regulations [part 11 of Title 21 of the Code of Federal Regulations; (21 CFR Part 11)] that provide criteria for acceptance of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper. These regulations, which apply to all FDA program areas, were intended to permit the widest possible use of electronic technology. After part 11 became effective in August 1997, discussions ensued among industry, contractors, and the Agency concerning the interpretation and implementation of the regulations.

FDA has (1) spoken about part 11 at many conferences and met numerous times with an industry coalition and other interested parties in an effort to hear more about potential part 11 issues; (2) published a compliance policy guide, CPG 7153.17: Enforcement Policy: 21 CFR Part 11; Electronic Records; Electronic Signatures; and (3) published numerous draft guidance documents including the following:

• 21 CFR Part 11; Electronic Records; Electronic Signatures, Validation
• 21 CFR Part 11; Electronic Records; Electronic Signatures, Glossary of Terms
• 21 CFR Part 11; Electronic Records; Electronic Signatures, Time Stamps
• 21 CFR Part 11; Electronic Records; Electronic Signatures, Maintenance of Electronic Records
• 21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records These documents can all be found at the FDA website (see References, below).

MDS Pharma Services Project
In the year 2000, a company-wide project at MDS Pharma Services was initiated to ensure that Part 11 regulations would be addressed in a consistent way across the entire organization. The challenge for this global company (1,100 employees; five sites among four countries) was to ensure project continuity and consistency. In reality, it was difficult to manage a single project plan so six individual project plans were created in support of the following business units:

• ECR
• BIO
• Drug Safety Assessment
• Discovery and Pharma Science
• Global Clinical Development
• Central Laboratory

An Interpretation Document was created by MDS PS and used at all sites. The Part 11 rules were interpreted for GLP, GCP and GMP environments.

Compliance Methodology
An on-going 5-phase process is used at all sites:

1. Phase 1: Inventory of software, instruments and data generation (system identifications)
2. Phase 2: Business risk assessment (priority)
3. Phase 3: Part 11 system assessment (systems evaluation against Part 11 requirement)
4. Phase 4: Compliance strategy (remedy to Part 11 deficiencies)
5. Phase 5: Implementation