In August 2003, the FDA issued the document "Guidance for Industry: Part 11, Electronic Records; Electronic Signatures — Scope and Application", which shared the Agency's current thinking regarding the scope and enforcement of 21 CFR Part 11 Electronic Records; Electronic Signatures. The guidance document assured a concerned industry and its suppliers that fewer records would be subject to the regulation, and that there would be some discretion when it came to enforcement of the requirements for validation, audit trails, record retention, record copying, and legacy systems (i.e., those systems in operation before Part 11 become effective in August 1997). This was to last until the Agency had time to re-think the regulation. Though many important aspects of Part 11 would still be enforced, they were more readily complied with, and the industry and its suppliers breathed a sigh of relief... and began to ramp up compliance, not knowing if/when the Agency would re-issue the regulation and begin full enforcement.
That breather may be about to come to an end.
Recently, one of my colleagues here at Tanis and I, along with a customer, were discussing whether we had seen a decrease in the amount of documentation generated since the industry more formally adopted a "risk-based" approach to validation. 
When faced with a new validation project, the considerations to weigh when making the "Outsource" vs. "Perform In-House" decision are similar to projects outside of validation:
I’ve spent 16 years in compliance-related positions on both sides of the table. I’ve seen a lot of validation companies and interacted with a lot of validation departments, and I can tell you they’re not all the same. Here’s some criteria to help differentiate between a good validation company (who will create and execute protocols for you) and a great validation company (who will offer so much more):
them about the great Computer Systems Validation (or similar) session we attended at the ISPE conference… last year! There’s just not enough opportunities for us to informally discuss these issues and share our knowledge.
